Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Low-Dose Fractionated Radiotherapy in Patients With Locally Advanced Metastatic Pancreatic 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: NCT00761345
Recruitment Status : Completed
First Posted : September 29, 2008
Results First Posted : March 31, 2016
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
Fox Chase Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Pancreatic Carcinoma Non-resectable
Metastatic Pancreatic Cancer
Interventions Drug: gemcitabine
Drug: Erlotinib
Radiation: low dose fractionated radiotherapy
Enrollment 27
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Radiotherapy and Chemotherapy
Hide Arm/Group Description

gemcitabine will be administered at 1000mg/m2 IV on days 1 and 8 of each 21 day cycle. erlotinib at either 100mg (cohort 1-3) or 150mg (cohort 4) PO daily. Low dose fractionated radiotherapy (LDRT) will be given BID on days 1 and 2 and 8 and 9 of each 21 day cycle

gemcitabine: gemcitabine 1000mg/m2 days 1 and 8 of each 21 day cycle.

Erlotinib: Erlotinib 100mg or 150mg daily of each 21 day cycle

low dose fractionated radiotherapy: low dose fractionated radiotherapy day 1 and 2, day 8 and 9 of each 21 day cycle

Period Title: Overall Study
Started 27
Completed 24
Not Completed 3
Arm/Group Title Radiotherapy and Chemotherapy
Hide Arm/Group Description

gemcitabine will be administered at 1000mg/m2 IV on days 1 and 8 of each 21 day cycle. erlotinib at either 100mg (cohort 1-3) or 150mg (cohort 4) PO daily. Low dose fractionated radiotherapy (LDRT) will be given BID on days 1 and 2 and 8 and 9 of each 21 day cycle

gemcitabine: gemcitabine 1000mg/m2 days 1 and 8 of each 21 day cycle.

Erlotinib: Erlotinib 100mg or 150mg daily of each 21 day cycle

low dose fractionated radiotherapy: low dose fractionated radiotherapy day 1 and 2, day 8 and 9 of each 21 day cycle

Overall Number of Baseline Participants 27
Hide Baseline Analysis Population Description
Patients with locally advanced or metastatic pancreatic cancer confined to the abdomen and an ECOG performance status (PS) of 0-1 who had received 0-1 prior regimens (without Gemcitabine or Erlotinib) and no prior radiotherapy were eligible
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
<=18 years
0
   0.0%
Between 18 and 65 years
16
  59.3%
>=65 years
11
  40.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Female
12
  44.4%
Male
15
  55.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants
27
1.Primary Outcome
Title To Determine the Dose Limiting Toxicities
Hide Description [Not Specified]
Time Frame weekly physician and nurse assessment and in between as needed until 30 days after treatment termination
Hide Outcome Measure Data
Hide Analysis Population Description
27 patients (median age 64years and 15 male) with locally advanced or metastatic pancreatic cancer confined to the abdomen and an ECOG performance status of 0-1 who had received 0-1 prior regimens (without Gemcitabine or Erlotinib) and no prior radiotherapy were eligible.
Arm/Group Title Radiotherapy and Chemotherapy
Hide Arm/Group Description:

gemcitabine will be administered at 1000mg/m2 IV on days 1 and 8 of each 21 day cycle. erlotinib at either 100mg (cohort 1-3) or 150mg (cohort 4) PO daily. Low dose fractionated radiotherapy (LDRT) will be given BID on days 1 and 2 and 8 and 9 of each 21 day cycle

gemcitabine: gemcitabine 1000mg/m2 days 1 and 8 of each 21 day cycle.

Erlotinib: Erlotinib 100mg or 150mg daily of each 21 day cycle

low dose fractionated radiotherapy: low dose fractionated radiotherapy day 1 and 2, day 8 and 9 of each 21 day cycle

Overall Number of Participants Analyzed 27
Measure Type: Number
Unit of Measure: participants
27
2.Secondary Outcome
Title To Measure Progression Free Survival and Overall Survival
Hide Description [Not Specified]
Time Frame Evaluate CT scans after every 2 cycles of therapy (about every 6 weeks) and long term follow up every 3 months once off treatment for survival
Outcome Measure Data Not Reported
Time Frame 3.5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Radiotherapy and Chemotherapy
Hide Arm/Group Description

gemcitabine will be administered at 1000mg/m2 IV on days 1 and 8 of each 21 day cycle. erlotinib at either 100mg (cohort 1-3) or 150mg (cohort 4) PO daily. Low dose fractionated radiotherapy (LDRT) will be given BID on days 1 and 2 and 8 and 9 of each 21 day cycle

gemcitabine: gemcitabine 1000mg/m2 days 1 and 8 of each 21 day cycle.

Erlotinib: Erlotinib 100mg or 150mg daily of each 21 day cycle

low dose fractionated radiotherapy: low dose fractionated radiotherapy day 1 and 2, day 8 and 9 of each 21 day cycle

All-Cause Mortality
Radiotherapy and Chemotherapy
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Radiotherapy and Chemotherapy
Affected / at Risk (%) # Events
Total   15/27 (55.56%)    
Gastrointestinal disorders   
Ileus  2/27 (7.41%)  2
GI bleed  1/27 (3.70%)  1
Diarrhea  2/27 (7.41%)  2
Perforated viscous  1/27 (3.70%)  1
Hepatobiliary disorders   
Biliary obstruction  1/27 (3.70%)  1
Metabolism and nutrition disorders   
Dehydration  4/27 (14.81%)  4
Respiratory, thoracic and mediastinal disorders   
Pneumonia  4/27 (14.81%)  4
Vascular disorders   
DVT  2/27 (7.41%)  2
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Radiotherapy and Chemotherapy
Affected / at Risk (%) # Events
Total   27/27 (100.00%)    
Blood and lymphatic system disorders   
hemoglobin   25/27 (92.59%)  120
ANC   14/27 (51.85%)  41
WBC   22/27 (81.48%)  84
Platelets   19/27 (70.37%)  68
Cardiac disorders   
Tachycardia  2/27 (7.41%)  2
Eye disorders   
watery eyes  1/27 (3.70%)  1
Gastrointestinal disorders   
Ascites  5/27 (18.52%)  18
GI bleed  1/27 (3.70%)  1
Nausea  20/27 (74.07%)  53
Vomiting  13/27 (48.15%)  35
Dysphagia  4/27 (14.81%)  6
Dyspesia  5/27 (18.52%)  10
Heartburn  3/27 (11.11%)  12
Constipation  10/27 (37.04%)  27
Ileus/bowel obstruction  1/27 (3.70%)  1
Bowel perforation  1/27 (3.70%)  1
Diarrhea  22/27 (81.48%)  65
Mucositis  1/27 (3.70%)  2
Dysgeusia  2/27 (7.41%)  6
Hemorrhoids  1/27 (3.70%)  3
Abdominal pain  12/27 (44.44%)  32
General disorders   
Edema   6/27 (22.22%)  15
Fever  6/27 (22.22%)  13
Fatigue  26/27 (96.30%)  107
Pain  16/27 (59.26%)  47
Chills  1/27 (3.70%)  2
Sweats  1/27 (3.70%)  2
Hepatobiliary disorders   
Jaundice  1/27 (3.70%)  1
Infections and infestations   
Infection, without neurtropenia  6/27 (22.22%)  10
Infection, with neutropenia  1/27 (3.70%)  1
Investigations   
Hyperbilirubinemia  5/27 (18.52%)  6
Alkaline phosphatase  15/27 (55.56%)  51
Creatinine  7/27 (25.93%)  10
SGOT/AST  12/27 (44.44%)  18
SGPT/ALT  7/27 (25.93%)  10
Hyperglycemia  18/27 (66.67%)  60
Hypoglycemia  2/27 (7.41%)  2
Hypoalbuminemia  23/27 (85.19%)  94
Hypokalemia  16/27 (59.26%)  38
Hyponatremia  16/27 (59.26%)  35
Hypocalcemia  8/27 (29.63%)  17
Lymphopenia  7/27 (25.93%)  19
Hypomagnesemia  6/27 (22.22%)  9
Low bicarbonate  1/27 (3.70%)  1
Metabolism and nutrition disorders   
Dehydration  8/27 (29.63%)  14
Anorexia  21/27 (77.78%)  69
Weight loss  14/27 (51.85%)  43
Musculoskeletal and connective tissue disorders   
Weakness  3/27 (11.11%)  5
Myalgia/Arthralgia  3/27 (11.11%)  6
Nervous system disorders   
Neuropathy, sensory  1/27 (3.70%)  5
Tremor  2/27 (7.41%)  8
Headache  1/27 (3.70%)  1
Dizziness  3/27 (11.11%)  3
Psychiatric disorders   
Insomnia  7/27 (25.93%)  15
Depression  10/27 (37.04%)  32
Renal and urinary disorders   
Dysuria  1/27 (3.70%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  8/27 (29.63%)  13
Epistaxis  2/27 (7.41%)  3
Dyspnea  10/27 (37.04%)  19
Pneumonia  1/27 (3.70%)  1
Skin and subcutaneous tissue disorders   
Alopecia  1/27 (3.70%)  2
Rash  18/27 (66.67%)  61
Dry desquamation  2/27 (7.41%)  2
Dry cracked skin  1/27 (3.70%)  2
Pruritis  1/27 (3.70%)  2
Radiation dermititis  1/27 (3.70%)  3
Vascular disorders   
DVT  1/27 (3.70%)  1
Hypertension  1/27 (3.70%)  3
Hemorrhage  1/27 (3.70%)  1
Hypotension  2/27 (7.41%)  2
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Steven J. Cohen
Organization: Fox Chase Cancer Center
Phone: 215-728-4300
EMail: steven.cohen@fccc.edu
Layout table for additonal information
Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT00761345     History of Changes
Other Study ID Numbers: FER-GI-021
OSI4485s ( Other Identifier: Genentech )
First Submitted: September 26, 2008
First Posted: September 29, 2008
Results First Submitted: January 22, 2015
Results First Posted: March 31, 2016
Last Update Posted: March 7, 2017