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Trial record 7 of 8 for:    UNISOM OR Unisom OR DOXYLAMINE OR Doxy-Sleep-Aid OR DOXYLAMINE SUCCINATE OR DECAPRYN OR Decapryn OR DOXY-SLEEP-AID

A Phase 1-2 Trial of Cetuximab in Combination With Oxaliplatin, Capecitabine, and Radiation Therapy Followed by Surgery for Locally-advanced Rectal 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: NCT00226941
Recruitment Status : Terminated (The response rate observed in the phase 1 portion of the study did not merit further evaluation in phase 2 portion of the study.)
First Posted : September 27, 2005
Results First Posted : December 8, 2017
Last Update Posted : December 8, 2017
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
George Albert Fisher, Stanford University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Rectal Cancer
Colo-rectal Cancer
Interventions Drug: Cetuximab
Drug: Oxaliplatin
Drug: Capecitabine
Radiation: Radiotherapy
Drug: Diphenhydramine hydrochloride (HCl)
Enrollment 23
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100 Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85 Group A - Cetuximab + Capecitabine-800 + XRT Group B - Cetuximab + Capecitabine-1000 + XRT
Hide Arm/Group Description
  • Cetuximab 250 mg/m² / week
  • Capecitabine 800 mg/m²
  • Radiotherapy (XRT)
  • Oxaliplatin 100 mg/m², Days 2 and 23
  • Cetuximab 250 mg/m² / week
  • Capecitabine 700 mg/m²
  • Radiotherapy (XRT)
  • Oxaliplatin 85mg/m², Days 2 and 23
  • Cetuximab 250 mg/m² / week
  • Capecitabine 1000 mg/m²
  • Radiotherapy (XRT)
  • Cetuximab 250 mg/m² / week
  • Capecitabine 1000 mg/m²
  • Radiotherapy (XRT)
Period Title: Overall Study
Started 6 6 4 7
Completed 6 6 4 5
Not Completed 0 0 0 2
Reason Not Completed
Withdrawal by subject - toxicity             0             0             0             1
Withdrawn by investigator - unrelated AE             0             0             0             1
Arm/Group Title Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100 Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85 Group A - Cetuximab + Capecitabine-800 + XRT Group B - Cetuximab + Capecitabine-1000 + XRT Total
Hide Arm/Group Description
  • Cetuximab 250 mg/m² / week
  • Capecitabine 800 mg/m²
  • Radiotherapy (XRT)
  • Oxaliplatin 100 mg/m², Days 2 and 23
  • Cetuximab 250 mg/m² / week
  • Capecitabine 700 mg/m²
  • Radiotherapy (XRT)
  • Oxaliplatin 85 mg/m², Days 2 and 23
  • Cetuximab 250 mg/m² / week
  • Capecitabine 800 mg/m²
  • Radiotherapy (XRT)
  • Cetuximab 250 mg/m² / week
  • Capecitabine 1000 mg/m²
  • Radiotherapy (XRT)
Total of all reporting groups
Overall Number of Baseline Participants 6 6 4 7 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 4 participants 7 participants 23 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
  83.3%
6
 100.0%
4
 100.0%
5
  71.4%
20
  87.0%
>=65 years
1
  16.7%
0
   0.0%
0
   0.0%
2
  28.6%
3
  13.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 4 participants 7 participants 23 participants
Female
1
  16.7%
2
  33.3%
0
   0.0%
2
  28.6%
5
  21.7%
Male
5
  83.3%
4
  66.7%
4
 100.0%
5
  71.4%
18
  78.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 4 participants 7 participants 23 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
1
   4.3%
Not Hispanic or Latino
6
 100.0%
6
 100.0%
4
 100.0%
6
  85.7%
22
  95.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 4 participants 7 participants 23 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
  16.7%
0
   0.0%
0
   0.0%
1
  14.3%
2
   8.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
4
  66.7%
6
 100.0%
4
 100.0%
5
  71.4%
19
  82.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
  16.7%
0
   0.0%
0
   0.0%
1
  14.3%
2
   8.7%
Histology  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 4 participants 7 participants 23 participants
Adenocarcinoid Tumor
0
   0.0%
0
   0.0%
1
  25.0%
4
  57.1%
5
  21.7%
Adenocarcinoma, Nos
6
 100.0%
6
 100.0%
2
  50.0%
3
  42.9%
17
  73.9%
Adenosarcoma
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
1
   4.3%
1.Primary Outcome
Title Dose-limiting Toxicity (DLT) - Number of DLTs by Treatment Group
Hide Description Dose-limiting Toxicity (DLT) is the measure used to establish overall Maximum-tolerated dose (MTD) of cetuximab + capecitabine + radiotherapy +/- oxaliplatin. MTD is defined as the highest dose level for which participants have a < 30% incidence of dose-limiting toxicity (DLT). The outcome is expressed as the number of DLTs by treatment group.
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were formally part of the phase 1 portion of this study.
Arm/Group Title Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100 Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85 Group A - Cetuximab + Capecitabine-800 + XRT Group B - Cetuximab + Capecitabine-1000 + XRT
Hide Arm/Group Description:
  • Cetuximab 250 mg/m² / week
  • Capecitabine 800 mg/m²
  • Radiotherapy (XRT)
  • Oxaliplatin 100 mg/m², Days 2 and 23
  • Cetuximab 250 mg/m² / week
  • Capecitabine 700 mg/m²
  • Radiotherapy (XRT)
  • Oxaliplatin 85 mg/m², Days 2 and 23
  • Cetuximab 250 mg/m² / week
  • Capecitabine 800 mg/m²
  • Radiotherapy (XRT)
  • Cetuximab 250 mg/m² / week
  • Capecitabine 1000 mg/m²
  • Radiotherapy (XRT)
Overall Number of Participants Analyzed 6 6 4 7
Measure Type: Number
Unit of Measure: DLTs
10 2 0 0
2.Primary Outcome
Title Dose-limiting Toxicity (DLT) - Number of Participants Affected
Hide Description Dose-limiting Toxicity (DLT) is the measure used to establish overall Maximum-tolerated dose (MTD) of cetuximab + capecitabine + radiotherapy +/- oxaliplatin. MTD is defined as the highest dose level for which participants have a < 30% incidence of dose-limiting toxicity (DLT). The outcome is expressed as the number of participants experiencing a DLT.
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were formally part of the phase 1 portion of this study.
Arm/Group Title Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100 Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85 Group A - Cetuximab + Capecitabine-800 + XRT Group B - Cetuximab + Capecitabine-1000 + XRT
Hide Arm/Group Description:
  • Cetuximab 250 mg/m² / week
  • Capecitabine 800 mg/m²
  • Radiotherapy (XRT)
  • Oxaliplatin 100 mg/m², Days 2 and 23
  • Cetuximab 250 mg/m² / week
  • Capecitabine 700 mg/m²
  • Radiotherapy (XRT)
  • Oxaliplatin 85mg/m², Days 2 and 23
  • Cetuximab 250 mg/m² / week
  • Capecitabine 1000 mg/m²
  • Radiotherapy (XRT)
  • Cetuximab 250 mg/m² / week
  • Capecitabine 1000 mg/m²
  • Radiotherapy (XRT)
Overall Number of Participants Analyzed 6 6 4 7
Measure Type: Count of Participants
Unit of Measure: Participants
4
  66.7%
2
  33.3%
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Pathologic Response Rate
Hide Description After treatment with capecitabine, cetuximab, radiotherapy, and oxaliplatin, the pathologic response rate was assessed based on the excised tumor taken at the time of surgical resection. Pathologic response rate was determined as the number and proportion of participants who experienced either downstaging of their disease, or complete response (CR, no detectable disease). A participant will be considered to have downstaging of the tumor as a result of the neoadjuvant therapy when the primary tumor (T) stage by pathology isless than the T stage by clinical (endoscopic) evaluation, or when the regional lymph node (N) tumor stage by pathology is less than the N stage by clinical (endoscopic) evaluation.
Time Frame 12 to 14 weeks after radiotherapy
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome is specifically defined per protocol as the phase 2 portion of the study, which did not occur. However, the data for this measure are available from the phase 1 participants (only), and are provided for completeness.
Arm/Group Title Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100 Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85 Group A - Cetuximab + Capecitabine-800 + XRT Group B - Cetuximab + Capecitabine-1000 + XRT
Hide Arm/Group Description:
  • Cetuximab 250 mg/m² / week
  • Capecitabine 800 mg/m²
  • Radiotherapy (XRT)
  • Oxaliplatin 100 mg/m², Days 2 and 23
  • Cetuximab 250 mg/m² / week
  • Capecitabine 700 mg/m²
  • Radiotherapy (XRT)
  • Oxaliplatin 85 mg/m², Days 2 and 23
  • Cetuximab 250 mg/m² / week
  • Capecitabine 800 mg/m²
  • Radiotherapy (XRT)
  • Cetuximab 250 mg/m² / week
  • Capecitabine 1000 mg/m²
  • Radiotherapy (XRT)
Overall Number of Participants Analyzed 5 6 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
4
  80.0%
5
  83.3%
3
  75.0%
5
 100.0%
4.Secondary Outcome
Title Tumor Downstaging at Surgical Resection
Hide Description Downstaging means a reduction from the stage of disease observed at baseline to the stage of disease after treatment with cetuximab, radiotherapy, oxaliplatin, and capecitabine, as determined at the time of surgical removal of the tumor. Downstaging may be observed as improvements in tumor staging at the primary site of the tumor; in nearby (regional) lymph nodes; or in metastatic disease beyond the regional lymph nodes. This outcome specifically does not include participants that achieved a complete response, nor those that experienced no response or disease progression.
Time Frame 12 to 14 weeks after radiotherapy
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome is specifically defined per protocol as the phase 2 portion of the study, which did not occur. However, the data for this measure are available from the phase 1 participants (only), and are provided for completeness.
Arm/Group Title Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100 Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85 Group A - Cetuximab + Capecitabine-800 + XRT Group B - Cetuximab + Capecitabine-1000 + XRT
Hide Arm/Group Description:
  • Cetuximab 250 mg/m² / week
  • Capecitabine 700 mg/m²
  • Radiotherapy (XRT)
  • Oxaliplatin 85 mg/m², Days 2 and 23
  • Cetuximab 250 mg/m² / week
  • Capecitabine 700 mg/m²
  • Radiotherapy (XRT)
  • Oxaliplatin 85 mg/m², Days 2 and 23
  • Cetuximab 250 mg/m² / week
  • Capecitabine 800 mg/m²
  • Radiotherapy (XRT)
  • Cetuximab 250 mg/m² / week
  • Capecitabine 1000 mg/m²
  • Radiotherapy (XRT)
Overall Number of Participants Analyzed 5 6 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
4
  80.0%
5
  83.3%
3
  75.0%
5
 100.0%
5.Secondary Outcome
Title Time-to-Progression (TTP)
Hide Description Time-to-progression was assessed as the time from the date of surgical resection to the appearance of either local disease recurrence or distant metastases by any modality (eg, clinical exam, endoscopy, radiographic imaging). All relapses were to be confirmed by biopsy and pathology review.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated before all patients reached 5 years from the date of surgical resection. Only patients that progressed are reported, and since no patients progressed in Group 2, median and range are not reportable.
Arm/Group Title Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100 Group 2 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-85 Group A - Cetuximab + Capecitabine-800 + XRT Group B - Cetuximab + Capecitabine-1000 + XRT
Hide Arm/Group Description:
  • Cetuximab 250 mg/m² / week
  • Capecitabine 800 mg/m²
  • Radiotherapy (XRT)
  • Oxaliplatin 100 mg/m², Days 2 and 23
  • Cetuximab 250 mg/m² / week
  • Capecitabine 700 mg/m²
  • Radiotherapy (XRT)
  • Oxaliplatin 85 mg/m², Days 2 and 23
  • Cetuximab 250 mg/m² / week
  • Capecitabine 800 mg/m²
  • Radiotherapy (XRT)
  • Cetuximab 250 mg/m² / week
  • Capecitabine 1000 mg/m²
  • Radiotherapy (XRT)
Overall Number of Participants Analyzed 2 0 1 3
Median (Full Range)
Unit of Measure: years
1.4
(0.8 to 2.0)
3.0
(3.0 to 3.0)
3.9
(0.2 to 5.0)
6.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall Survival (OS) was assessed as the mean survival from the date of entry on study though 72 months.
Time Frame 72 months
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome is defined per protocol as study phase 2, which did not occur. However, data are provided for phase 1 participants, for completeness. This study was terminated before all patients reached 5 years on study. Some patients are reported as the last known alive date.
Arm/Group Title Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100 Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85 Group A - Cetuximab + Capecitabine-800 + XRT Group B - Cetuximab + Capecitabine-1000 + XRT
Hide Arm/Group Description:
  • Cetuximab 250 mg/m² / week
  • Capecitabine 800 mg/m²
  • Radiotherapy (XRT)
  • Oxaliplatin 100 mg/m², Days 2 and 23
  • Cetuximab 250 mg/m² / week
  • Capecitabine 700 mg/m²
  • Radiotherapy (XRT)
  • Oxaliplatin 85 mg/m², Days 2 and 23
  • Cetuximab 250 mg/m² / week
  • Capecitabine 800 mg/m²
  • Radiotherapy (XRT)
  • Cetuximab 250 mg/m² / week
  • Capecitabine 1000 mg/m²
  • Radiotherapy (XRT)
Overall Number of Participants Analyzed 6 6 4 5
Mean (Standard Deviation)
Unit of Measure: months
59.7  (0.7) 57.0  (5.8) 54.4  (11.1) 53.7  (11.3)
7.Secondary Outcome
Title Survival at 5 Years
Hide Description Survival at 5 years was assessed as the number of participants alive 5 years after starting treatment.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome is defined per protocol as study phase 2, which did not occur. However, data are available from the phase 1 participants (only), and are provided for completeness. This study was terminated before all patients reached 5 years from study entry. Only patients known to be alive at 5 years are reported.
Arm/Group Title Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100 Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85 Group A - Cetuximab + Capecitabine-800 + XRT Group B - Cetuximab + Capecitabine-800 + XRT
Hide Arm/Group Description:
  • Cetuximab 250 mg/m² / week
  • Capecitabine 800 mg/m²
  • Radiotherapy (XRT)
  • Oxaliplatin 100 mg/m², Days 2 and 23
  • Cetuximab 250 mg/m² / week
  • Capecitabine 700 mg/m²
  • Radiotherapy (XRT)
  • Oxaliplatin 850 mg/m², Days 2 and 23
  • Cetuximab 250 mg/m² / week
  • Capecitabine 800 mg/m²
  • Radiotherapy (XRT)
  • Cetuximab 250 mg/m² / week
  • Capecitabine 1000 mg/m²
  • Radiotherapy (XRT)
Overall Number of Participants Analyzed 6 6 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
5
  83.3%
4
  66.7%
3
  75.0%
3
  60.0%
Time Frame 5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100 Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85 Group A - Cetuximab + Capecitabine-800 + XRT Group B - Cetuximab + Capecitabine-1000 + XRT
Hide Arm/Group Description
  • Cetuximab 250 mg/m² / week
  • Capecitabine 800 mg/m²
  • Radiotherapy (XRT)
  • Oxaliplatin 100 mg/m², Days 2 and 23
  • Cetuximab 250 mg/m² / week
  • Capecitabine 700 mg/m²
  • Radiotherapy (XRT)
  • Oxaliplatin 85 mg/m², Days 2 and 23
  • Cetuximab 250 mg/m² / week
  • Capecitabine 800 mg/m²
  • Radiotherapy (XRT)
  • Cetuximab 250 mg/m² / week
  • Capecitabine 1000 mg/m²
  • Radiotherapy (XRT)
All-Cause Mortality
Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100 Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85 Group A - Cetuximab + Capecitabine-800 + XRT Group B - Cetuximab + Capecitabine-1000 + XRT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/6 (16.67%)      1/6 (16.67%)      0/4 (0.00%)      0/7 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100 Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85 Group A - Cetuximab + Capecitabine-800 + XRT Group B - Cetuximab + Capecitabine-1000 + XRT
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/6 (100.00%)      6/6 (100.00%)      3/4 (75.00%)      7/7 (100.00%)    
Gastrointestinal disorders         
Small bowel obstruction-Ileus * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1
Anorexia * 1  3/6 (50.00%)  4 1/6 (16.67%)  1 2/4 (50.00%)  2 1/7 (14.29%)  1
Dehydration * 1  3/6 (50.00%)  3 2/6 (33.33%)  2 0/4 (0.00%)  0 1/7 (14.29%)  1
Diarrhea * 1  5/6 (83.33%)  8 2/6 (33.33%)  7 0/4 (0.00%)  0 5/7 (71.43%)  12
Vomiting * 1  3/6 (50.00%)  4 2/6 (33.33%)  2 0/4 (0.00%)  0 1/7 (14.29%)  1
Infections and infestations         
Urinary Tract Infection * 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Decrease in lung volumes with increased bibasilar atelectasis * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1
Nausea * 1  6/6 (100.00%)  11 1/6 (16.67%)  2 1/4 (25.00%)  1 2/7 (28.57%)  2
1
Term from vocabulary, CTCAE 3.0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 1 - Cetuximab + Capecitabine-800 + XRT + Oxaliplatin-100 Group 2 - Cetuximab + Capecitabine-700 + XRT + Oxaliplatin-85 Group A - Cetuximab + Capecitabine-800 + XRT Group B - Cetuximab + Capecitabine-1000 + XRT
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/6 (100.00%)      6/6 (100.00%)      4/4 (100.00%)      7/7 (100.00%)    
Blood and lymphatic system disorders         
Hemorrhage in rectum * 1  3/6 (50.00%)  3 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Hypokalemia * 1  0/6 (0.00%)  0 1/6 (16.67%)  1 1/4 (25.00%)  1 1/7 (14.29%)  1
Hematocrit decreased * 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Neutropenia * 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Cardiac disorders         
Hypertension * 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Tachycardia * 1  1/6 (16.67%)  2 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Ear and labyrinth disorders         
Pain, middle ear * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1
Endocrine disorders         
Hypomagnesemia * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/4 (25.00%)  1 1/7 (14.29%)  1
Eye disorders         
Dry eye syndrome * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/4 (25.00%)  1 0/7 (0.00%)  0
Gastrointestinal disorders         
Abdominal cramping * 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1
Abdominal pain * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 2/7 (28.57%)  2
Anorexia * 1  4/6 (66.67%)  4 1/6 (16.67%)  1 3/4 (75.00%)  3 2/7 (28.57%)  2
Backache * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1
Distension * 1  3/6 (50.00%)  3 1/6 (16.67%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
Bloody stool * 1  0/6 (0.00%)  0 2/6 (33.33%)  2 1/4 (25.00%)  1 4/7 (57.14%)  5
Bloody rectum * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1
Constipation * 1  3/6 (50.00%)  3 1/6 (16.67%)  2 1/4 (25.00%)  1 0/7 (0.00%)  0
Constipation, alternating with diarrhea * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/4 (25.00%)  3 0/7 (0.00%)  0
Diarrhea * 1  5/6 (83.33%)  10 2/6 (33.33%)  7 0/4 (0.00%)  0 4/7 (57.14%)  11
Diarrhea with cramping * 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Flatus * 1  2/6 (33.33%)  2 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Gastritis * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1
Hemorrhoids * 1  2/6 (33.33%)  2 2/6 (33.33%)  2 1/4 (25.00%)  1 0/7 (0.00%)  0
Nausea * 1  6/6 (100.00%)  14 1/6 (16.67%)  2 2/4 (50.00%)  2 2/7 (28.57%)  2
Pain with bowel movements * 1  4/6 (66.67%)  4 0/6 (0.00%)  0 1/4 (25.00%)  2 3/7 (42.86%)  3
Vomiting * 1  3/6 (50.00%)  4 2/6 (33.33%)  2 0/4 (0.00%)  0 1/7 (14.29%)  1
Pain, umbilical cord protrusion * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/4 (25.00%)  1 0/7 (0.00%)  0
Reflux * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1
General disorders         
Chest tightness * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/4 (25.00%)  1 0/7 (0.00%)  0
Dehydration * 1  2/6 (33.33%)  2 2/6 (33.33%)  2 0/4 (0.00%)  0 1/7 (14.29%)  1
Migraine * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1
Weight loss * 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Taste disturbance * 1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
Infection, rectal-anal * 1  3/6 (50.00%)  3 5/6 (83.33%)  6 2/4 (50.00%)  2 2/7 (28.57%)  2
Pain * 1  2/6 (33.33%)  2 4/6 (66.67%)  5 1/4 (25.00%)  1 2/7 (28.57%)  2
Pain (t11-12 level) * 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Immune system disorders         
Fatigue * 1  4/6 (66.67%)  7 1/6 (16.67%)  2 2/4 (50.00%)  2 1/7 (14.29%)  1
Infections and infestations         
Pain * 1  1/6 (16.67%)  1 0/6 (0.00%)  0 1/4 (25.00%)  1 0/7 (0.00%)  0
Infection * 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Fever * 1  4/6 (66.67%)  4 0/6 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1
Candidal infection * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/4 (25.00%)  3 0/7 (0.00%)  0
Flu-like symptoms * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/4 (25.00%)  1 0/7 (0.00%)  0
Low grade fever * 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Infection, urinary track (UTI) * 1  1/6 (16.67%)  2 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Infection, upper respiratory tract * 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%) 
Rhinitis * 1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
Injury, poisoning and procedural complications         
Pain, groin * 1  2/6 (33.33%)  2 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Injection site reaction * 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Pain, left knee * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/4 (25.00%)  1 0/7 (0.00%)  0
Pain, lower back * 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Investigations         
Insomnia * 1  3/6 (50.00%)  3 0/6 (0.00%)  0 1/4 (25.00%)  1 0/7 (0.00%)  0
Syncope * 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Bilateral jaw pain * 1  1/6 (16.67%)  1 0/6 (0.00%)  0 1/4 (25.00%)  1 0/7 (0.00%)  0
Body aches * 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Cramping * 1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/4 (0.00%)  0 2/7 (28.57%)  2
Hand and foot syndrome * 1  2/6 (33.33%)  3 0/6 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1
Left arm numbness * 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Tingling, fingertips * 1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
Tingling, cheeks * 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Nervous system disorders         
Rigors * 1  2/6 (33.33%)  3 0/6 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1
Neuropathy * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1
Dizziness * 1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/4 (0.00%)  0 1/7 (14.29%)  1
Depression * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1
Cold sensitivity * 1  2/6 (33.33%)  2 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Headache * 1  2/6 (33.33%)  2 1/6 (16.67%)  1 2/4 (50.00%)  2 2/7 (28.57%)  2
Lightheadedness * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/4 (25.00%)  1 0/7 (0.00%)  0
Nocturia * 1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
Neuropathy, right arm * 1  2/6 (33.33%)  4 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Renal and urinary disorders         
Urinary frequency * 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Elevated alanine aminotransferase (ALT) * 1  2/6 (33.33%)  2 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Elevated aspartate aminotransferase (AST) * 1  2/6 (33.33%)  2 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Abnormal liver function test (LFT) * 1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
Urinary retention * 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Urinary hesitancy * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/4 (25.00%)  1 0/7 (0.00%)  0
Blood in stool, scant * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/4 (25.00%)  1 0/7 (0.00%)  0
Pain, bladder and testes * 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Reproductive system and breast disorders         
Libido * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1
Respiratory, thoracic and mediastinal disorders         
Allergic reaction * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1
Cough * 1  1/6 (16.67%)  2 0/6 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1
Dyspnea * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1
Flushing * 1  1/6 (16.67%)  1 1/6 (16.67%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
Pain, throat * 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1
Skin and subcutaneous tissue disorders         
Acne * 1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
Edema * 1  1/6 (16.67%)  1 1/6 (16.67%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
Skin cracking * 1  1/6 (16.67%)  1 1/6 (16.67%)  2 0/4 (0.00%)  0 3/7 (42.86%)  3
Cuticle dryness * 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 1/7 (14.29%)  1
Erythema at incision * 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Rash, follicular, chest and back * 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Induration * 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Skin dryness * 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/4 (0.00%)  0 0/7 (0.00%)  0
Radiation demititis * 1  2/6 (33.33%)  3 0/6 (0.00%)  0 1/4 (25.00%)  1 0/7 (0.00%)  0
Rash * 1  6/6 (100.00%)  11 6/6 (100.00%)  10 4/4 (100.00%)  7 5/7 (71.43%)  12
Psoriasis * 1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/4 (0.00%)  0 0/7 (0.00%)  0
1
Term from vocabulary, CTCAE 3.0
*
Indicates events were collected by non-systematic assessment

This trial was halted after the phase 1 portion of enrollment, and before the phase 2 portion accrued.

Data reported for phase 2 objectives/outcomes do not include any phase 2 participants, and are only provided for completeness.

Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Name/Title: George Albert Fisher, Jr, MD, PhD; Colleen Haas Chair, School of Medicine
Organization: Stanford Cancer Institute, Stanford University
Phone: 650-723-2990
Responsible Party: George Albert Fisher, Stanford University
ClinicalTrials.gov Identifier: NCT00226941     History of Changes
Other Study ID Numbers: IRB-12426
COR0001 ( Other Identifier: OnCore )
95054 ( Other Identifier: Stanford IRB, historical )
First Submitted: September 8, 2005
First Posted: September 27, 2005
Results First Submitted: July 27, 2017
Results First Posted: December 8, 2017
Last Update Posted: December 8, 2017