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S1201: Combination Chemo for Patients W/Advanced or Metastatic Esophageal, Gastric, or Gastroesophageal Junction Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01498289
Recruitment Status : Completed
First Posted : December 23, 2011
Results First Posted : August 29, 2019
Last Update Posted : November 7, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adenocarcinoma of the Gastroesophageal Junction
Esophageal Cancer
Gastric Cancer
Interventions Drug: FOLFOX regimen
Drug: docetaxel
Drug: fluorouracil
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
Drug: oxaliplatin
Enrollment 213
Recruitment Details  
Pre-assignment Details 213 participants were randomized, but six were ineligible and 5 were excluded from analysis due to death or withdrawal prior to randomization. Therefore 202 were deemed eligible and analyzable for the primary analysis.
Arm/Group Title Arm I Arm II
Hide Arm/Group Description

FOLFOX regimen: participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, & leucovorin calcium.

fluorouracil: 400 mg/m^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle.

leucovorin calcium: 400 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle.

oxaliplatin: 85 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle.

IT regimen: participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

docetaxel: 30 mg/m^2, IV over 30 minutes on Day 1,8 of each 21 day cycle.

irinotecan hydrochloride: 65 mg/m^2, IV over 90 minutes on Days 1 & 8 of every 21 day cycle.

Period Title: Overall Study
Started 98 104
Participants Assessed for AEs 91 98
Completed 0 0
Not Completed 98 104
Reason Not Completed
Adverse Event             16             18
Death             6             8
Withdrawal unrelated to AE             16             16
Progression/relapse             53             59
Not protocol specified             7             2
Reason under review             0             1
Arm/Group Title Arm I Arm II Total
Hide Arm/Group Description

FOLFOX regimen: Participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, & leucovorin calcium.

fluorouracil: 400 mg/m^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle.

leucovorin calcium: 400 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle.

oxaliplatin: 85 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle.

Participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

docetaxel: 30 mg/m^2, IV over 30 minutes on Day 1,8 of each 21 day cycle.

irinotecan hydrochloride: 65 mg/m^2, IV over 90 minutes on Days 1 & 8 of every 21 day cycle.

Total of all reporting groups
Overall Number of Baseline Participants 98 104 202
Hide Baseline Analysis Population Description
213 participants were randomized, but six were ineligible and 5 were excluded from analysis due to death or withdrawal prior to randomization. Therefore 202 were deemed eligible and analyzable for the primary analysis.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 98 participants 104 participants 202 participants
62.5
(21.5 to 85.6)
62.4
(33.7 to 84.8)
62.5
(21.5 to 85.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants 104 participants 202 participants
Female
20
  20.4%
21
  20.2%
41
  20.3%
Male
78
  79.6%
83
  79.8%
161
  79.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants 104 participants 202 participants
Hispanic or Latino
12
  12.2%
19
  18.3%
31
  15.3%
Not Hispanic or Latino
83
  84.7%
83
  79.8%
166
  82.2%
Unknown or Not Reported
3
   3.1%
2
   1.9%
5
   2.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants 104 participants 202 participants
American Indian or Alaska Native
1
   1.0%
0
   0.0%
1
   0.5%
Asian
5
   5.1%
8
   7.7%
13
   6.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
   7.1%
6
   5.8%
13
   6.4%
White
83
  84.7%
80
  76.9%
163
  80.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   2.0%
10
   9.6%
12
   5.9%
ERCC1  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants 104 participants 202 participants
High (>=1.7)
13
  13.3%
15
  14.4%
28
  13.9%
Low (<1.7)
85
  86.7%
89
  85.6%
174
  86.1%
Site of Disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 98 participants 104 participants 202 participants
Esophageal
33
  33.7%
36
  34.6%
69
  34.2%
Gastric/GEJ
65
  66.3%
68
  65.4%
133
  65.8%
1.Primary Outcome
Title Progression-free Survival (PFS) in High-ERCC1 Patients
Hide Description Progression-free survival is the length of time between protocol registration and disease progression or death, whichever occurs first.
Time Frame Up to 3 years after registration
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and analyzable participants with ERCC1 level >= 1.7
Arm/Group Title Arm I FOLFOX Arm II IT
Hide Arm/Group Description:

FOLFOX regimen: Participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, & leucovorin calcium.

fluorouracil: 400 mg/m^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle.

leucovorin calcium: 400 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle.

oxaliplatin: 85 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle.

IT regimen: Participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

docetaxel: 30 mg/m^2, IV over 30 minutes on Day 1,8 of each 21 day cycle.

irinotecan hydrochloride: 65 mg/m^2, IV over 90 minutes on Days 1 & 8 of every 21 day cycle.

Overall Number of Participants Analyzed 13 15
Median (95% Confidence Interval)
Unit of Measure: months
4.7
(2.1 to 8.7)
5.3
(0.9 to 11.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I FOLFOX, Arm II IT
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.83
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.41 to 2.05
Estimation Comments [Not Specified]
2.Primary Outcome
Title PFS in Low-ERCC1 Participants
Hide Description Progression-free survival is the length of time between protocol registration and disease progression or death, whichever occurs first.
Time Frame Up to 3 years after registration
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and analyzable participants with ERCC1 level < 1.7
Arm/Group Title Arm I Arm II
Hide Arm/Group Description:

FOLFOX regimen: Participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, & leucovorin calcium.

fluorouracil: 400 mg/m^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle.

leucovorin calcium: 400 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle.

oxaliplatin: 85 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle.

IT regimen: Participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

docetaxel: 30 mg/m^2, IV over 30 minutes on Day 1,8 of each 21 day cycle.

irinotecan hydrochloride: 65 mg/m^2, IV over 90 minutes on Days 1 & 8 of every 21 day cycle.

Overall Number of Participants Analyzed 85 89
Median (95% Confidence Interval)
Unit of Measure: months
5.9
(4.1 to 7.1)
2.8
(1.7 to 4.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I, Arm II
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.68
Confidence Interval (2-Sided) 95%
0.50 to 0.93
Estimation Comments [Not Specified]
3.Primary Outcome
Title Overall Survival (OS)
Hide Description OS is the length of time between protocol registration and patient death
Time Frame Up to 3 years after registration
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and analyzable participants
Arm/Group Title Arm I Arm II
Hide Arm/Group Description:

FOLFOX regimen: Participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, & leucovorin calcium.

fluorouracil: 400 mg/m^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle.

leucovorin calcium: 400 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle.

oxaliplatin: 85 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle.

IT regimen: Participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

docetaxel: 30 mg/m^2, IV over 30 minutes on Day 1,8 of each 21 day cycle.

irinotecan hydrochloride: 65 mg/m^2, IV over 90 minutes on Days 1 & 8 of every 21 day cycle.

Overall Number of Participants Analyzed 98 104
Median (95% Confidence Interval)
Unit of Measure: months
11.4
(9.8 to 13.5)
8.7
(6.0 to 10.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I, Arm II
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.20
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
0.61 to 1.11
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Overall Response Rate (ORR)
Hide Description

ORR (complete response, unconfirmed complete response, partial response, unconfirmed partial response) in patients with measurable disease were assessed in each arm and compared between arms using Chi-squared test.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Time Frame Up to 3 years after registration
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with measurable disease
Arm/Group Title Arm I Arm II
Hide Arm/Group Description:

FOLFOX regimen: Participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, & leucovorin calcium.

fluorouracil: 400 mg/m^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle.

leucovorin calcium: 400 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle.

oxaliplatin: 85 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle.

IT regimen: Participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

docetaxel: 30 mg/m^2, IV over 30 minutes on Day 1,8 of each 21 day cycle.

irinotecan hydrochloride: 65 mg/m^2, IV over 90 minutes on Days 1 & 8 of every 21 day cycle.

Overall Number of Participants Analyzed 79 88
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of evaluable participants
42
(31 to 53)
30
(20 to 39)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I, Arm II
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
5.Secondary Outcome
Title PFS Variation by ERCC1
Hide Description

Progression-free survival is the length of time between protocol registration and disease progression or death, whichever occurs first.

Participants were divided into subgroups according to ERCC1 quartiles to assess whether the differences in PFS between the two treatment arms varied by ERCC1 levels.

Time Frame up to 3 years after registration
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and analyzable participants were divided into quartiles based on ERCC1 levels.
Arm/Group Title Arm I Arm II
Hide Arm/Group Description:

FOLFOX regimen: Participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, & leucovorin calcium.

fluorouracil: 400 mg/m^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle.

leucovorin calcium: 400 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle.

oxaliplatin: 85 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle.

IT regimen: Participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

docetaxel: 30 mg/m^2, IV over 30 minutes on Day 1,8 of each 21 day cycle.

irinotecan hydrochloride: 65 mg/m^2, IV over 90 minutes on Days 1 & 8 of every 21 day cycle.

Overall Number of Participants Analyzed 98 104
Median (95% Confidence Interval)
Unit of Measure: months
Q1 ERCC1 (0.20-0.80) Number Analyzed 24 participants 26 participants
5.6
(2.4 to 8.3)
2.8
(1.4 to 4.9)
Q2 ERCC1 (0.81-1.10) Number Analyzed 25 participants 26 participants
7.4
(4.1 to 9.1)
3.0
(1.9 to 4.2)
Q3 ERCC1 (1.11-1.42) Number Analyzed 27 participants 23 participants
5.6
(2.9 to 7.0)
2.9
(1.0 to 4.7)
Q4 ERCC1 (1.43-5.71) Number Analyzed 22 participants 29 participants
4.6
(2.1 to 8.7)
2.6
(1.3 to 5.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I, Arm II
Comments Statistical analysis for Q1 ERCC1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.78
Confidence Interval (2-Sided) 95%
0.44 to 1.40
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm I, Arm II
Comments Statistical analysis for Q2 ERCC1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.57
Confidence Interval (2-Sided) 95%
0.32 to 1.02
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Arm I, Arm II
Comments Statistical analysis for Q3 ERCC1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.66
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.49 to 1.58
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Arm I, Arm II
Comments Statistical analysis for Q4 ERCC1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.30
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.74
Confidence Interval (2-Sided) 95%
0.42 to 1.31
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Hide Description Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time Frame Duration of treatment and follow up until death or 3 years post registration
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least one dose of protocol treatment and were thus eligible for AE assessment
Arm/Group Title Arm I FOLFOX Arm II IT
Hide Arm/Group Description:
FOLFOX regimen: participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, and leucovorin calcium.
IT regimen: participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. docetaxel: 30 mg/m^2, IV over 30 minutes on Day 1,8 of each 21 day cycle.
Overall Number of Participants Analyzed 91 98
Measure Type: Number
Unit of Measure: Participants
Abdominal pain 1 0
Activated partial thromboplastin time prolonged 0 1
Acute kidney injury 0 1
Alanine aminotransferase increased 2 1
Alkaline phosphatase increased 1 1
Allergic reaction 1 0
Anemia 6 14
Anorexia 0 7
Aspartate aminotransferase increased 2 5
Back pain 0 1
Bladder infection 0 1
Blood bilirubin increased 1 1
Bone pain 1 0
CD4 lymphocytes decreased 0 3
Confusion 1 0
Death NOS 1 0
Dehydration 2 19
Depression 1 0
Diarrhea 4 28
Dry mouth 1 0
Dysphagia 1 1
Edema limbs 0 1
Esophageal hemorrhage 0 1
Esophagitis 0 1
Fatigue 7 14
Febrile neutropenia 1 6
Gastrointestinal pain 0 1
Generalized muscle weakness 2 2
Headache 0 1
Heart failure 0 1
Hyperglycemia 1 1
Hypertension 1 1
Hypoalbuminemia 1 4
Hypocalcemia 0 2
Hypokalemia 2 8
Hypomagnesemia 0 2
Hyponatremia 2 5
Hypotension 1 3
INR increased 0 1
Infections and infestations - Other, specify 0 1
Infusion related reaction 1 0
Leukocytosis 0 1
Lung infection 1 1
Lymphocyte count decreased 9 7
Mucositis oral 2 1
Multi-organ failure 0 2
Nausea 7 12
Neutrophil count decreased 29 19
Non-cardiac chest pain 0 1
Obstruction gastric 1 0
Palmar-plantar erythrodysesthesia syndrome 1 0
Peripheral motor neuropathy 1 0
Peripheral sensory neuropathy 10 1
Platelet count decreased 5 1
Pneumonitis 0 1
Respiratory failure 0 2
Sepsis 1 6
Stomach pain 0 2
Syncope 1 2
Thromboembolic event 1 0
Upper gastrointestinal hemorrhage 0 1
Urinary tract infection 0 1
Vascular access complication 0 1
Vomiting 5 8
Weight loss 0 2
White blood cell decreased 9 14
Time Frame Duration of treatment and follow up until death or 3 years post registration
Adverse Event Reporting Description

Population description for all-cause mortality: all eligible and analyzable participants

Population description for AEs: participants who received at least one dose of protocol treatment and were thus assessed for AEs

 
Arm/Group Title Arm I FOLFOX Arm II IT
Hide Arm/Group Description FOLFOX regimen: participants receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. FOLFOX regimen: Given IV. Fluorouracil, oxaliplatin, and leucovorin calcium. IT regimen: participants receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. docetaxel: 30 mg/m^2, IV over 30 minutes on Day 1,8 of each 21 day cycle.
All-Cause Mortality
Arm I FOLFOX Arm II IT
Affected / at Risk (%) Affected / at Risk (%)
Total   89/98 (90.82%)   94/104 (90.38%) 
Hide Serious Adverse Events
Arm I FOLFOX Arm II IT
Affected / at Risk (%) Affected / at Risk (%)
Total   7/91 (7.69%)   17/98 (17.35%) 
Gastrointestinal disorders     
Diarrhea   0/91 (0.00%)  1/98 (1.02%) 
Mucositis oral   1/91 (1.10%)  0/98 (0.00%) 
General disorders     
Death NOS   2/91 (2.20%)  4/98 (4.08%) 
Multi-organ failure   0/91 (0.00%)  2/98 (2.04%) 
Sudden death NOS   1/91 (1.10%)  0/98 (0.00%) 
Infections and infestations     
Lung infection   1/91 (1.10%)  0/98 (0.00%) 
Sepsis   1/91 (1.10%)  6/98 (6.12%) 
Investigations     
Alanine aminotransferase increased   1/91 (1.10%)  0/98 (0.00%) 
Aspartate aminotransferase increased   1/91 (1.10%)  0/98 (0.00%) 
Neutrophil count decreased   1/91 (1.10%)  0/98 (0.00%) 
White blood cell decreased   0/91 (0.00%)  1/98 (1.02%) 
Metabolism and nutrition disorders     
Dehydration   0/91 (0.00%)  1/98 (1.02%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified - Other   0/91 (0.00%)  5/98 (5.10%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory failure   0/91 (0.00%)  2/98 (2.04%) 
Vascular disorders     
Hypotension   0/91 (0.00%)  1/98 (1.02%) 
Thromboembolic event   0/91 (0.00%)  1/98 (1.02%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I FOLFOX Arm II IT
Affected / at Risk (%) Affected / at Risk (%)
Total   88/91 (96.70%)   95/98 (96.94%) 
Blood and lymphatic system disorders     
Anemia   65/91 (71.43%)  70/98 (71.43%) 
Febrile neutropenia   1/91 (1.10%)  6/98 (6.12%) 
Leukocytosis   0/91 (0.00%)  2/98 (2.04%) 
Lymph node pain   1/91 (1.10%)  0/98 (0.00%) 
Cardiac disorders     
Atrial fibrillation   1/91 (1.10%)  0/98 (0.00%) 
Cardiac disorders-Other   1/91 (1.10%)  0/98 (0.00%) 
Heart failure   0/91 (0.00%)  1/98 (1.02%) 
Sinus bradycardia   1/91 (1.10%)  1/98 (1.02%) 
Sinus tachycardia   2/91 (2.20%)  9/98 (9.18%) 
Ear and labyrinth disorders     
Hearing impaired   2/91 (2.20%)  1/98 (1.02%) 
Tinnitus   1/91 (1.10%)  0/98 (0.00%) 
Endocrine disorders     
Endocrine disorders-Other   0/91 (0.00%)  1/98 (1.02%) 
Hypothyroidism   0/91 (0.00%)  1/98 (1.02%) 
Eye disorders     
Blurred vision   6/91 (6.59%)  4/98 (4.08%) 
Conjunctivitis   1/91 (1.10%)  0/98 (0.00%) 
Dry eye   2/91 (2.20%)  3/98 (3.06%) 
Eye disorders-Other   0/91 (0.00%)  3/98 (3.06%) 
Eye pain   2/91 (2.20%)  0/98 (0.00%) 
Vitreous hemorrhage   0/91 (0.00%)  1/98 (1.02%) 
Watering eyes   2/91 (2.20%)  5/98 (5.10%) 
Gastrointestinal disorders     
Abdominal distension   3/91 (3.30%)  3/98 (3.06%) 
Abdominal pain   32/91 (35.16%)  40/98 (40.82%) 
Anal fistula   0/91 (0.00%)  1/98 (1.02%) 
Anal hemorrhage   1/91 (1.10%)  0/98 (0.00%) 
Ascites   5/91 (5.49%)  4/98 (4.08%) 
Bloating   2/91 (2.20%)  5/98 (5.10%) 
Constipation   43/91 (47.25%)  33/98 (33.67%) 
Diarrhea   33/91 (36.26%)  68/98 (69.39%) 
Dry mouth   6/91 (6.59%)  3/98 (3.06%) 
Dyspepsia   6/91 (6.59%)  7/98 (7.14%) 
Dysphagia   25/91 (27.47%)  23/98 (23.47%) 
Esophageal hemorrhage   1/91 (1.10%)  1/98 (1.02%) 
Esophageal obstruction   1/91 (1.10%)  0/98 (0.00%) 
Esophageal pain   3/91 (3.30%)  4/98 (4.08%) 
Esophageal stenosis   1/91 (1.10%)  0/98 (0.00%) 
Esophagitis   1/91 (1.10%)  6/98 (6.12%) 
Fecal incontinence   0/91 (0.00%)  1/98 (1.02%) 
Flatulence   7/91 (7.69%)  8/98 (8.16%) 
Gastric fistula   1/91 (1.10%)  0/98 (0.00%) 
Gastric hemorrhage   0/91 (0.00%)  1/98 (1.02%) 
Gastritis   1/91 (1.10%)  1/98 (1.02%) 
Gastroesophageal reflux disease   8/91 (8.79%)  4/98 (4.08%) 
Gastrointestinal disorders-Other   3/91 (3.30%)  3/98 (3.06%) 
Gastrointestinal pain   2/91 (2.20%)  2/98 (2.04%) 
Gastroparesis   0/91 (0.00%)  1/98 (1.02%) 
Hemorrhoidal hemorrhage   1/91 (1.10%)  0/98 (0.00%) 
Hemorrhoids   4/91 (4.40%)  1/98 (1.02%) 
Ileus   0/91 (0.00%)  2/98 (2.04%) 
Jejunal stenosis   0/91 (0.00%)  1/98 (1.02%) 
Lip pain   1/91 (1.10%)  0/98 (0.00%) 
Lower gastrointestinal hemorrhage   1/91 (1.10%)  0/98 (0.00%) 
Malabsorption   0/91 (0.00%)  1/98 (1.02%) 
Mucositis oral   30/91 (32.97%)  9/98 (9.18%) 
Nausea   60/91 (65.93%)  62/98 (63.27%) 
Obstruction gastric   1/91 (1.10%)  1/98 (1.02%) 
Oral hemorrhage   1/91 (1.10%)  0/98 (0.00%) 
Oral pain   1/91 (1.10%)  2/98 (2.04%) 
Rectal hemorrhage   2/91 (2.20%)  0/98 (0.00%) 
Small intestinal obstruction   1/91 (1.10%)  1/98 (1.02%) 
Stomach pain   2/91 (2.20%)  4/98 (4.08%) 
Toothache   3/91 (3.30%)  0/98 (0.00%) 
Upper gastrointestinal hemorrhage   1/91 (1.10%)  2/98 (2.04%) 
Vomiting   38/91 (41.76%)  44/98 (44.90%) 
General disorders     
Chills   9/91 (9.89%)  5/98 (5.10%) 
Edema face   0/91 (0.00%)  2/98 (2.04%) 
Edema limbs   20/91 (21.98%)  25/98 (25.51%) 
Edema trunk   0/91 (0.00%)  1/98 (1.02%) 
Facial pain   3/91 (3.30%)  0/98 (0.00%) 
Fatigue   74/91 (81.32%)  71/98 (72.45%) 
Fever   6/91 (6.59%)  12/98 (12.24%) 
Flu like symptoms   2/91 (2.20%)  0/98 (0.00%) 
Gait disturbance   1/91 (1.10%)  1/98 (1.02%) 
General disorders and admin site conditions - Other   3/91 (3.30%)  0/98 (0.00%) 
Infusion related reaction   2/91 (2.20%)  2/98 (2.04%) 
Injection site reaction   0/91 (0.00%)  1/98 (1.02%) 
Irritability   1/91 (1.10%)  0/98 (0.00%) 
Localized edema   0/91 (0.00%)  2/98 (2.04%) 
Malaise   1/91 (1.10%)  2/98 (2.04%) 
Non-cardiac chest pain   5/91 (5.49%)  6/98 (6.12%) 
Pain   8/91 (8.79%)  6/98 (6.12%) 
Hepatobiliary disorders     
Gallbladder pain   0/91 (0.00%)  1/98 (1.02%) 
Portal vein thrombosis   0/91 (0.00%)  1/98 (1.02%) 
Immune system disorders     
Allergic reaction   6/91 (6.59%)  3/98 (3.06%) 
Infections and infestations     
Bladder infection   0/91 (0.00%)  2/98 (2.04%) 
Bronchial infection   1/91 (1.10%)  0/98 (0.00%) 
Enterocolitis infectious   0/91 (0.00%)  1/98 (1.02%) 
Eye infection   0/91 (0.00%)  1/98 (1.02%) 
Infections and infestations-Other   2/91 (2.20%)  4/98 (4.08%) 
Lip infection   0/91 (0.00%)  1/98 (1.02%) 
Lung infection   0/91 (0.00%)  2/98 (2.04%) 
Lymph gland infection   1/91 (1.10%)  0/98 (0.00%) 
Mucosal infection   1/91 (1.10%)  2/98 (2.04%) 
Otitis media   0/91 (0.00%)  1/98 (1.02%) 
Peritoneal infection   0/91 (0.00%)  1/98 (1.02%) 
Rhinitis infective   1/91 (1.10%)  1/98 (1.02%) 
Sepsis   1/91 (1.10%)  1/98 (1.02%) 
Sinusitis   3/91 (3.30%)  0/98 (0.00%) 
Skin infection   3/91 (3.30%)  4/98 (4.08%) 
Tooth infection   0/91 (0.00%)  3/98 (3.06%) 
Tracheitis   0/91 (0.00%)  1/98 (1.02%) 
Upper respiratory infection   5/91 (5.49%)  5/98 (5.10%) 
Urinary tract infection   0/91 (0.00%)  1/98 (1.02%) 
Vaginal infection   1/91 (1.10%)  0/98 (0.00%) 
Wound infection   0/91 (0.00%)  1/98 (1.02%) 
Injury, poisoning and procedural complications     
Bruising   3/91 (3.30%)  0/98 (0.00%) 
Burn   1/91 (1.10%)  0/98 (0.00%) 
Fall   2/91 (2.20%)  3/98 (3.06%) 
Fracture   1/91 (1.10%)  0/98 (0.00%) 
Injury, poison and procedural complications - Other   1/91 (1.10%)  0/98 (0.00%) 
Vascular access complication   0/91 (0.00%)  1/98 (1.02%) 
Investigations     
Activated partial thromboplastin time prolonged   0/91 (0.00%)  2/98 (2.04%) 
Alanine aminotransferase increased   19/91 (20.88%)  20/98 (20.41%) 
Alkaline phosphatase increased   39/91 (42.86%)  31/98 (31.63%) 
Aspartate aminotransferase increased   26/91 (28.57%)  28/98 (28.57%) 
Blood bilirubin increased   13/91 (14.29%)  10/98 (10.20%) 
CD4 lymphocytes decreased   4/91 (4.40%)  7/98 (7.14%) 
Cholesterol high   2/91 (2.20%)  2/98 (2.04%) 
Creatinine increased   2/91 (2.20%)  13/98 (13.27%) 
Ejection fraction decreased   0/91 (0.00%)  1/98 (1.02%) 
INR increased   1/91 (1.10%)  3/98 (3.06%) 
Investigations-Other   0/91 (0.00%)  2/98 (2.04%) 
Lipase increased   0/91 (0.00%)  2/98 (2.04%) 
Lymphocyte count decreased   27/91 (29.67%)  26/98 (26.53%) 
Neutrophil count decreased   47/91 (51.65%)  30/98 (30.61%) 
Platelet count decreased   50/91 (54.95%)  12/98 (12.24%) 
Serum amylase increased   0/91 (0.00%)  1/98 (1.02%) 
Weight gain   5/91 (5.49%)  2/98 (2.04%) 
Weight loss   37/91 (40.66%)  32/98 (32.65%) 
White blood cell decreased   50/91 (54.95%)  41/98 (41.84%) 
Metabolism and nutrition disorders     
Anorexia   40/91 (43.96%)  46/98 (46.94%) 
Dehydration   13/91 (14.29%)  35/98 (35.71%) 
Glucose intolerance   0/91 (0.00%)  3/98 (3.06%) 
Hypercalcemia   1/91 (1.10%)  2/98 (2.04%) 
Hyperglycemia   42/91 (46.15%)  36/98 (36.73%) 
Hyperkalemia   3/91 (3.30%)  7/98 (7.14%) 
Hypermagnesemia   1/91 (1.10%)  1/98 (1.02%) 
Hypernatremia   2/91 (2.20%)  4/98 (4.08%) 
Hypertriglyceridemia   1/91 (1.10%)  0/98 (0.00%) 
Hyperuricemia   1/91 (1.10%)  0/98 (0.00%) 
Hypoalbuminemia   44/91 (48.35%)  51/98 (52.04%) 
Hypocalcemia   30/91 (32.97%)  34/98 (34.69%) 
Hypoglycemia   5/91 (5.49%)  4/98 (4.08%) 
Hypokalemia   20/91 (21.98%)  31/98 (31.63%) 
Hypomagnesemia   6/91 (6.59%)  9/98 (9.18%) 
Hyponatremia   21/91 (23.08%)  35/98 (35.71%) 
Hypophosphatemia   2/91 (2.20%)  4/98 (4.08%) 
Metabolism and nutrition disorders - Other, specify   3/91 (3.30%)  3/98 (3.06%) 
Musculoskeletal and connective tissue disorders     
Arthralgia   7/91 (7.69%)  12/98 (12.24%) 
Back pain   13/91 (14.29%)  12/98 (12.24%) 
Bone pain   3/91 (3.30%)  3/98 (3.06%) 
Buttock pain   1/91 (1.10%)  1/98 (1.02%) 
Chest wall pain   3/91 (3.30%)  1/98 (1.02%) 
Flank pain   1/91 (1.10%)  0/98 (0.00%) 
Generalized muscle weakness   9/91 (9.89%)  17/98 (17.35%) 
Joint effusion   0/91 (0.00%)  1/98 (1.02%) 
Muscle weakness lower limb   0/91 (0.00%)  2/98 (2.04%) 
Muscle weakness upper limb   0/91 (0.00%)  1/98 (1.02%) 
Musculoskeletal and connective tiss disorder - Other   5/91 (5.49%)  1/98 (1.02%) 
Myalgia   7/91 (7.69%)  5/98 (5.10%) 
Neck pain   4/91 (4.40%)  1/98 (1.02%) 
Pain in extremity   12/91 (13.19%)  6/98 (6.12%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified - Other   1/91 (1.10%)  1/98 (1.02%) 
Tumor pain   0/91 (0.00%)  1/98 (1.02%) 
Nervous system disorders     
Ataxia   1/91 (1.10%)  2/98 (2.04%) 
Cognitive disturbance   1/91 (1.10%)  1/98 (1.02%) 
Depressed level of consciousness   0/91 (0.00%)  1/98 (1.02%) 
Dizziness   16/91 (17.58%)  20/98 (20.41%) 
Dysesthesia   1/91 (1.10%)  0/98 (0.00%) 
Dysgeusia   19/91 (20.88%)  19/98 (19.39%) 
Dysphasia   1/91 (1.10%)  2/98 (2.04%) 
Extrapyramidal disorder   1/91 (1.10%)  0/98 (0.00%) 
Headache   11/91 (12.09%)  9/98 (9.18%) 
Hypersomnia   0/91 (0.00%)  1/98 (1.02%) 
Ischemia cerebrovascular   1/91 (1.10%)  0/98 (0.00%) 
Memory impairment   0/91 (0.00%)  2/98 (2.04%) 
Nervous system disorders-Other   3/91 (3.30%)  0/98 (0.00%) 
Paresthesia   18/91 (19.78%)  3/98 (3.06%) 
Peripheral motor neuropathy   4/91 (4.40%)  1/98 (1.02%) 
Peripheral sensory neuropathy   57/91 (62.64%)  18/98 (18.37%) 
Sinus pain   0/91 (0.00%)  2/98 (2.04%) 
Stroke   1/91 (1.10%)  0/98 (0.00%) 
Syncope   4/91 (4.40%)  4/98 (4.08%) 
Tremor   1/91 (1.10%)  2/98 (2.04%) 
Psychiatric disorders     
Anxiety   15/91 (16.48%)  16/98 (16.33%) 
Confusion   3/91 (3.30%)  2/98 (2.04%) 
Delirium   1/91 (1.10%)  0/98 (0.00%) 
Depression   15/91 (16.48%)  9/98 (9.18%) 
Hallucinations   1/91 (1.10%)  0/98 (0.00%) 
Insomnia   14/91 (15.38%)  13/98 (13.27%) 
Libido decreased   1/91 (1.10%)  0/98 (0.00%) 
Personality change   1/91 (1.10%)  0/98 (0.00%) 
Psychiatric disorders-Other   1/91 (1.10%)  0/98 (0.00%) 
Suicidal ideation   1/91 (1.10%)  0/98 (0.00%) 
Renal and urinary disorders     
Acute kidney injury   2/91 (2.20%)  3/98 (3.06%) 
Chronic kidney disease   2/91 (2.20%)  3/98 (3.06%) 
Hematuria   2/91 (2.20%)  0/98 (0.00%) 
Proteinuria   0/91 (0.00%)  2/98 (2.04%) 
Renal calculi   1/91 (1.10%)  0/98 (0.00%) 
Urinary frequency   2/91 (2.20%)  3/98 (3.06%) 
Urinary retention   2/91 (2.20%)  2/98 (2.04%) 
Reproductive system and breast disorders     
Irregular menstruation   1/91 (1.10%)  0/98 (0.00%) 
Nipple deformity   0/91 (0.00%)  1/98 (1.02%) 
Testicular pain   0/91 (0.00%)  1/98 (1.02%) 
Vaginal hemorrhage   1/91 (1.10%)  0/98 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis   5/91 (5.49%)  6/98 (6.12%) 
Aspiration   2/91 (2.20%)  1/98 (1.02%) 
Atelectasis   0/91 (0.00%)  1/98 (1.02%) 
Bronchopulmonary hemorrhage   1/91 (1.10%)  1/98 (1.02%) 
Cough   20/91 (21.98%)  21/98 (21.43%) 
Dyspnea   16/91 (17.58%)  20/98 (20.41%) 
Epistaxis   11/91 (12.09%)  5/98 (5.10%) 
Hiccups   4/91 (4.40%)  7/98 (7.14%) 
Hoarseness   1/91 (1.10%)  1/98 (1.02%) 
Hypoxia   1/91 (1.10%)  2/98 (2.04%) 
Laryngopharyngeal dysesthesia   3/91 (3.30%)  0/98 (0.00%) 
Nasal congestion   5/91 (5.49%)  2/98 (2.04%) 
Pharyngeal mucositis   0/91 (0.00%)  1/98 (1.02%) 
Pharyngolaryngeal pain   1/91 (1.10%)  0/98 (0.00%) 
Pleural effusion   2/91 (2.20%)  6/98 (6.12%) 
Pleuritic pain   0/91 (0.00%)  1/98 (1.02%) 
Pneumonitis   0/91 (0.00%)  1/98 (1.02%) 
Postnasal drip   2/91 (2.20%)  1/98 (1.02%) 
Productive cough   4/91 (4.40%)  4/98 (4.08%) 
Resp, thoracic and mediastinal disorders - Other   5/91 (5.49%)  1/98 (1.02%) 
Respiratory failure   0/91 (0.00%)  1/98 (1.02%) 
Sinus disorder   1/91 (1.10%)  1/98 (1.02%) 
Sneezing   1/91 (1.10%)  0/98 (0.00%) 
Sore throat   5/91 (5.49%)  3/98 (3.06%) 
Voice alteration   1/91 (1.10%)  3/98 (3.06%) 
Wheezing   1/91 (1.10%)  1/98 (1.02%) 
Skin and subcutaneous tissue disorders     
Alopecia   10/91 (10.99%)  30/98 (30.61%) 
Dry skin   11/91 (12.09%)  10/98 (10.20%) 
Hyperhidrosis   2/91 (2.20%)  5/98 (5.10%) 
Nail discoloration   0/91 (0.00%)  4/98 (4.08%) 
Nail loss   0/91 (0.00%)  2/98 (2.04%) 
Nail ridging   0/91 (0.00%)  4/98 (4.08%) 
Pain of skin   0/91 (0.00%)  1/98 (1.02%) 
Palmar-plantar erythrodysesthesia syndrome   8/91 (8.79%)  2/98 (2.04%) 
Pruritus   5/91 (5.49%)  6/98 (6.12%) 
Rash acneiform   1/91 (1.10%)  5/98 (5.10%) 
Rash maculo-papular   7/91 (7.69%)  7/98 (7.14%) 
Skin and subcutaneous tissue disorders - Other   5/91 (5.49%)  0/98 (0.00%) 
Skin hyperpigmentation   4/91 (4.40%)  0/98 (0.00%) 
Skin ulceration   1/91 (1.10%)  1/98 (1.02%) 
Urticaria   0/91 (0.00%)  1/98 (1.02%) 
Vascular disorders     
Flushing   0/91 (0.00%)  1/98 (1.02%) 
Hematoma   0/91 (0.00%)  1/98 (1.02%) 
Hot flashes   5/91 (5.49%)  2/98 (2.04%) 
Hypertension   18/91 (19.78%)  15/98 (15.31%) 
Hypotension   7/91 (7.69%)  19/98 (19.39%) 
Thromboembolic event   10/91 (10.99%)  7/98 (7.14%) 
Vascular disorders-Other   0/91 (0.00%)  1/98 (1.02%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: SWOG Statistician
Organization: SWOG Statistics and Data Management Center
Phone: 2066674623
EMail: mduong@fredhutch.org
Layout table for additonal information
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT01498289    
Other Study ID Numbers: S1201
S1201 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
NCI-2012-00096 ( Other Identifier: CTRP )
First Submitted: December 22, 2011
First Posted: December 23, 2011
Results First Submitted: July 15, 2019
Results First Posted: August 29, 2019
Last Update Posted: November 7, 2019