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Phase II Study of Preoperative FOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel in Patients With Resectable Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT02243007
Recruitment Status : Terminated (Slow Accrual)
First Posted : September 17, 2014
Results First Posted : May 16, 2017
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):
David Patrick Ryan, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Resectable Pancreatic Cancer
Pancreatic Ductal Carcinoma
Interventions Drug: FOLFIRINOX
Drug: Gemcitabine/nab-Paclitaxel
Radiation: Radiation therapy
Drug: Capecitabine
Enrollment 7
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Folfirinox-ARM A Gemcitabine/Nab-Paclitaxel- Arm B
Hide Arm/Group Description

Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel

  • Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.
  • After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.
  • Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer

FOLFIRINOX

Radiation therapy

Capecitabine

  • Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).
  • Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.
  • After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine
  • Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer

Gemcitabine/nab-Paclitaxel

Radiation therapy

Capecitabine

Period Title: Overall Study
Started 4 3
Completed 4 3
Not Completed 0 0
Arm/Group Title Folfirinox-ARM A Gemcitabine/Nab-Paclitaxel- Arm B Total
Hide Arm/Group Description

Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel

  • Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.
  • After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.
  • Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer

FOLFIRINOX

Radiation therapy

Capecitabine

  • Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).
  • Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.
  • After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine
  • Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer

Gemcitabine/nab-Paclitaxel

Radiation therapy

Capecitabine

Total of all reporting groups
Overall Number of Baseline Participants 4 3 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants 3 participants 7 participants
63.4
(49.4 to 68.3)
71.9
(59.9 to 74.1)
65.6
(49.4 to 74.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 7 participants
Female
1
  25.0%
1
  33.3%
2
  28.6%
Male
3
  75.0%
2
  66.7%
5
  71.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 3 participants 7 participants
4 3 7
1.Primary Outcome
Title Survival Rate at 18 Month
Hide Description Number of participants surviving after 18 months of study follow-up
Time Frame 18 Month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Folfirinox-ARM A Gemcitabine/Nab-Paclitaxel- Arm B
Hide Arm/Group Description:

Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel

  • Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.
  • After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.
  • Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer

FOLFIRINOX

Radiation therapy

Capecitabine

  • Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).
  • Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.
  • After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine
  • Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer

Gemcitabine/nab-Paclitaxel

Radiation therapy

Capecitabine

Overall Number of Participants Analyzed 4 3
Measure Type: Count of Participants
Unit of Measure: Participants
2
  50.0%
3
 100.0%
2.Secondary Outcome
Title Pathologic Complete Response Rate (pCR).
Hide Description Number of patients achieving pathologic complete response at 18 months. Pathologic complete response is defined as the absence of residual invasive disease in the panaceas and in the regional lymph nodes.
Time Frame 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
No Data available. Study terminated before any patients reached 18 months of follow-up. Patients were not able to be evaluated for response.
Arm/Group Title Folfirinox-ARM A Gemcitabine/Nab-Paclitaxel- Arm B
Hide Arm/Group Description:

Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel

  • Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.
  • After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.
  • Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer

FOLFIRINOX

Radiation therapy

Capecitabine

  • Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).
  • Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.
  • After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine
  • Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer

Gemcitabine/nab-Paclitaxel

Radiation therapy

Capecitabine

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Overall Survival Rate
Hide Description Overall survival rate at five years using Kaplan-Meier survival analysis
Time Frame Baseline, 5 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated before endpoint was reached, no data available
Arm/Group Title Folfirinox-ARM A Gemcitabine/Nab-Paclitaxel- Arm B
Hide Arm/Group Description:

Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel

  • Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.
  • After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.
  • Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer

FOLFIRINOX

Radiation therapy

Capecitabine

  • Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).
  • Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.
  • After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine
  • Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer

Gemcitabine/nab-Paclitaxel

Radiation therapy

Capecitabine

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Number of Participants With Serious and Non-Serious Adverse Events
Hide Description Number of Participants with Serious and Non-Serious Adverse Events from baseline to 28 days
Time Frame Baseline, 28 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Folfirinox-ARM A Gemcitabine/Nab-Paclitaxel- Arm B
Hide Arm/Group Description:

Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel

  • Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.
  • After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.
  • Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer

FOLFIRINOX

Radiation therapy

Capecitabine

  • Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).
  • Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.
  • After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine
  • Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer

Gemcitabine/nab-Paclitaxel

Radiation therapy

Capecitabine

Overall Number of Participants Analyzed 4 3
Measure Type: Number
Unit of Measure: participants
Serious Adverse Events 0 2
Other Adverse Events 4 3
5.Secondary Outcome
Title Surgical Morbidity Rate
Hide Description Number of patients experiencing a specific surgery related morbidity
Time Frame within 30 days of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Study ended prematurely, no results available
Arm/Group Title Folfirinox-ARM A Gemcitabine/Nab-Paclitaxel- Arm B
Hide Arm/Group Description:

Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel

  • Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.
  • After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.
  • Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer

FOLFIRINOX

Radiation therapy

Capecitabine

  • Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).
  • Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.
  • After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine
  • Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer

Gemcitabine/nab-Paclitaxel

Radiation therapy

Capecitabine

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title 30-day Post-operative Mortality Rate
Hide Description Number of patients who died following surgery.
Time Frame 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Study ended prematurely, no results available
Arm/Group Title Folfirinox-ARM A Gemcitabine/Nab-Paclitaxel- Arm B
Hide Arm/Group Description:

Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel

  • Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.
  • After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.
  • Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer

FOLFIRINOX

Radiation therapy

Capecitabine

  • Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).
  • Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.
  • After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine
  • Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer

Gemcitabine/nab-Paclitaxel

Radiation therapy

Capecitabine

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Correlation of Biomarkers With PFS
Hide Description Analysis of the correlation between selected bio-markers and progression free survival.
Time Frame 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Data not available. Study was terminated before endpoint was able to be evaluated
Arm/Group Title Folfirinox-ARM A Gemcitabine/Nab-Paclitaxel- Arm B
Hide Arm/Group Description:

Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel

  • Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.
  • After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.
  • Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer

FOLFIRINOX

Radiation therapy

Capecitabine

  • Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).
  • Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.
  • After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine
  • Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer

Gemcitabine/nab-Paclitaxel

Radiation therapy

Capecitabine

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Rate of Pathologic Downstaging
Hide Description The number of participants achieving a reduction in the pathological staging of the primary cancer.
Time Frame 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Data not available. Study was terminated before endpoint was able to be evaluated
Arm/Group Title Folfirinox-ARM A Gemcitabine/Nab-Paclitaxel- Arm B
Hide Arm/Group Description:

Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel

  • Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.
  • After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.
  • Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer

FOLFIRINOX

Radiation therapy

Capecitabine

  • Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).
  • Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.
  • After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine
  • Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer

Gemcitabine/nab-Paclitaxel

Radiation therapy

Capecitabine

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Local Control Rate
Hide Description The number of participants achieving local control. The local control rate is defined as the number of participants achieving stable disease, partial response, or a complete response.
Time Frame 2 Years
Hide Outcome Measure Data
Hide Analysis Population Description
Data not available. Study was terminated before endpoint was able to be evaluated
Arm/Group Title Folfirinox-ARM A Gemcitabine/Nab-Paclitaxel- Arm B
Hide Arm/Group Description:

Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel

  • Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.
  • After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.
  • Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer

FOLFIRINOX

Radiation therapy

Capecitabine

  • Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).
  • Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.
  • After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine
  • Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer

Gemcitabine/nab-Paclitaxel

Radiation therapy

Capecitabine

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Toxicity was assessed on day 1 of each cycle for the FOLFIRINOX arm and on Day 1, 8, 15 of each cycle for the Gem/Nab-P arm while being treated. Toxicity was assessed weekly during neoadjuvant radiation treatment and Capecitabine. Toxicity was planned to be assessed every 6 months during the first 3 years of post treatment follow-up.
Adverse Event Reporting Description Toxicity was assessed with the use of physical exams, laboratory tests, and patient self reports.
 
Arm/Group Title Folfirinox-ARM A Gemcitabine/Nab-Paclitaxel- Arm B
Hide Arm/Group Description

Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel

  • Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.
  • After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.
  • Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer

FOLFIRINOX

Radiation therapy

Capecitabine

  • Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).
  • Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.
  • After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine
  • Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer

Gemcitabine/nab-Paclitaxel

Radiation therapy

Capecitabine

All-Cause Mortality
Folfirinox-ARM A Gemcitabine/Nab-Paclitaxel- Arm B
Affected / at Risk (%) Affected / at Risk (%)
Total   2/4 (50.00%)      0/3 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Folfirinox-ARM A Gemcitabine/Nab-Paclitaxel- Arm B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      2/3 (66.67%)    
Investigations     
Neutrophil count decreased  1  0/4 (0.00%)  1/3 (33.33%) 
Blood bilirubin increased  1  0/4 (0.00%)  1/3 (33.33%) 
Vascular disorders     
hypotension  1  0/4 (0.00%)  1/3 (33.33%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Folfirinox-ARM A Gemcitabine/Nab-Paclitaxel- Arm B
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/4 (100.00%)      3/3 (100.00%)    
Blood and lymphatic system disorders     
Hemolytic uremic syndrome  1  0/4 (0.00%)  0 1/3 (33.33%)  1
Eye disorders     
Dry eye  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Eye disorders - Other, specify  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Eye pain  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Optic nerve disorder  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  3/4 (75.00%)  5 3/3 (100.00%)  3
Constipation  1  1/4 (25.00%)  1 2/3 (66.67%)  3
Diarrhea  1  3/4 (75.00%)  7 2/3 (66.67%)  3
Flatulence  1  2/4 (50.00%)  3 0/3 (0.00%)  0
Gastrointestinal disorders - Other, specify  1  1/4 (25.00%)  1 1/3 (33.33%)  1
Hemorrhoids  1  0/4 (0.00%)  0 1/3 (33.33%)  1
Malabsorption  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Mucositis oral  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Nausea  1  3/4 (75.00%)  6 2/3 (66.67%)  6
Vomiting  1  1/4 (25.00%)  1 1/3 (33.33%)  2
General disorders     
Edema limbs  1  0/4 (0.00%)  0 2/3 (66.67%)  2
Fatigue  1  4/4 (100.00%)  6 3/3 (100.00%)  4
Fever  1  1/4 (25.00%)  1 2/3 (66.67%)  2
Hepatobiliary disorders     
Cholecystitis  1  0/4 (0.00%)  0 1/3 (33.33%)  1
Infections and infestations     
Infections and infestations - Other, specify  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Injury, poisoning and procedural complications     
Ankle fracture  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Bruising  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Investigations     
Alanine aminotransferase increased  1  2/4 (50.00%)  2 1/3 (33.33%)  2
Aspartate aminotransferase increased  1  0/4 (0.00%)  0 1/3 (33.33%)  2
Blood bilirubin increased  1  0/4 (0.00%)  0 1/3 (33.33%)  1
Neutrophil count decreased  1  0/4 (0.00%)  0 1/3 (33.33%)  2
Platelet count decreased  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Weight loss  1  2/4 (50.00%)  2 1/3 (33.33%)  2
Metabolism and nutrition disorders     
Anorexia  1  3/4 (75.00%)  4 2/3 (66.67%)  2
Dehydration  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Hypokalemia  1  0/4 (0.00%)  0 1/3 (33.33%)  1
Hyponatremia  1  0/4 (0.00%)  0 1/3 (33.33%)  1
Musculoskeletal and connective tissue disorders     
Back pain  1  1/4 (25.00%)  1 1/3 (33.33%)  1
Muscle weakness lower limb  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Musculoskeletal and connective tissue disorder - Other, specify  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Myalgia  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Pain in extremity  1  1/4 (25.00%)  1 1/3 (33.33%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Nervous system disorders     
Dizziness  1  1/4 (25.00%)  2 0/3 (0.00%)  0
Dysesthesia  1  1/4 (25.00%)  2 0/3 (0.00%)  0
Dysgeusia  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Dysphasia  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Headache  1  2/4 (50.00%)  2 0/3 (0.00%)  0
Paresthesia  1  1/4 (25.00%)  2 0/3 (0.00%)  0
Peripheral motor neuropathy  1  1/4 (25.00%)  3 0/3 (0.00%)  0
Peripheral sensory neuropathy  1  1/4 (25.00%)  1 1/3 (33.33%)  1
Spasticity  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Psychiatric disorders     
Anxiety  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Insomnia  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Renal and urinary disorders     
Renal and urinary disorders - Other, specify  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Urine discoloration  1  0/4 (0.00%)  0 1/3 (33.33%)  1
Reproductive system and breast disorders     
Menorrhagia  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Dyspnea  1  0/4 (0.00%)  0 1/3 (33.33%)  1
Sore throat  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Wheezing  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Skin and subcutaneous tissue disorders     
Alopecia  1  1/4 (25.00%)  1 1/3 (33.33%)  1
Pruritus  1  0/4 (0.00%)  0 1/3 (33.33%)  1
Rash maculo-papular  1  0/4 (0.00%)  0 1/3 (33.33%)  2
Skin and subcutaneous tissue disorders - Other, specify  1  1/4 (25.00%)  1 0/3 (0.00%)  0
Skin/subcutaneous tissue disorders; Other, specify  1  1/4 (25.00%)  1 0/3 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
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: David P. Ryan, MD
Organization: Massachusetts General Hospital
Phone: 6177240245
EMail: dpryan@mgh.harvard.edu
Layout table for additonal information
Responsible Party: David Patrick Ryan, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02243007     History of Changes
Other Study ID Numbers: 14-218
First Submitted: September 15, 2014
First Posted: September 17, 2014
Results First Submitted: November 16, 2016
Results First Posted: May 16, 2017
Last Update Posted: May 16, 2017