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Combination Chemotherapy and Bevacizumab Before Surgery and Radiolabeled Monoclonal Antibody Therapy in Treating Liver Metastases in Patients With Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT01320683
Recruitment Status : Terminated (Slow accrual.)
First Posted : March 22, 2011
Results First Posted : June 20, 2016
Last Update Posted : July 19, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Liver Metastases
Recurrent Colon Cancer
Recurrent Rectal Cancer
Stage IVA Colon Cancer
Stage IVA Rectal Cancer
Stage IVB Colon Cancer
Stage IVB Rectal Cancer
Interventions Drug: oxaliplatin
Drug: leucovorin calcium
Drug: fluorouracil
Biological: bevacizumab
Radiation: yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A
Other: laboratory biomarker analysis
Other: pharmacological study
Drug: irinotecan hydrochloride
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Combination Chemotherapy and Radioimmunotherapy)
Hide Arm/Group Description FOLFOX* + BEVACIZUMAB CHEMOTHERAPY: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 12 courses in the absence of disease progression or unacceptable toxicity. RIT: Within 4-12 weeks after completion of post-hepatic resection therapy chemotherapy, patients receive yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A IV over 25 minutes. Treatment repeats every 6-10 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. NOTE:*Patients previously failing oxaliplatin regimen receive FOLIFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes, leucovorin calcium over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 1
Completed 0
Not Completed 1
Reason Not Completed
Positive antibody response             1
Arm/Group Title Treatment (Combination Chemotherapy and Radioimmunotherapy)
Hide Arm/Group Description FOLFOX* + BEVACIZUMAB CHEMOTHERAPY: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 12 courses in the absence of disease progression or unacceptable toxicity. RIT: Within 4-12 weeks after completion of post-hepatic resection therapy chemotherapy, patients receive yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A IV over 25 minutes. Treatment repeats every 6-10 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. NOTE:*Patients previously failing oxaliplatin regimen receive FOLIFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes, leucovorin calcium over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 1 participants
66
(66 to 66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
1
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
1.Primary Outcome
Title Progression-free Survival
Hide Description

Estimated using the product-limit method of Kaplan-Meier, and 95% confidence limits calculated for these estimates.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Time Frame Up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Combination Chemotherapy and Radioimmunotherapy)
Hide Arm/Group Description:
FOLFOX* + BEVACIZUMAB CHEMOTHERAPY: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 12 courses in the absence of disease progression or unacceptable toxicity. RIT: Within 4-12 weeks after completion of post-hepatic resection therapy chemotherapy, patients receive yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A IV over 25 minutes. Treatment repeats every 6-10 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. NOTE:*Patients previously failing oxaliplatin regimen receive FOLIFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes, leucovorin calcium over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Overall Survival
Hide Description Overall Survival is calculated for all patients from the date of initial treatment to date of death due to any cause. Patients who were still alive were censored at the date of last follow-up. Survival rates were estimates using the Kaplan-Meier method, and 95% confidence limits calculated for these estimates.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Combination Chemotherapy and Radioimmunotherapy)
Hide Arm/Group Description:
FOLFOX* + BEVACIZUMAB CHEMOTHERAPY: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 12 courses in the absence of disease progression or unacceptable toxicity. RIT: Within 4-12 weeks after completion of post-hepatic resection therapy chemotherapy, patients receive yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A IV over 25 minutes. Treatment repeats every 6-10 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. NOTE:*Patients previously failing oxaliplatin regimen receive FOLIFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes, leucovorin calcium over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events occurred over a two month period
Adverse Event Reporting Description All adverse events are included regardless of grade and attribution.
 
Arm/Group Title Treatment (Combination Chemotherapy and Radioimmunotherapy)
Hide Arm/Group Description FOLFOX* + BEVACIZUMAB CHEMOTHERAPY: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 12 courses in the absence of disease progression or unacceptable toxicity. RIT: Within 4-12 weeks after completion of post-hepatic resection therapy chemotherapy, patients receive yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A IV over 25 minutes. Treatment repeats every 6-10 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. NOTE:*Patients previously failing oxaliplatin regimen receive FOLIFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes, leucovorin calcium over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 6 courses in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Treatment (Combination Chemotherapy and Radioimmunotherapy)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Combination Chemotherapy and Radioimmunotherapy)
Affected / at Risk (%) # Events
Total   0/1 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Combination Chemotherapy and Radioimmunotherapy)
Affected / at Risk (%) # Events
Total   1/1 (100.00%)    
Ear and labyrinth disorders   
Vestibular disorder *  1/1 (100.00%)  1
Gastrointestinal disorders   
Diarrhea *  1/1 (100.00%)  1
Nausea *  1/1 (100.00%)  1
General disorders   
Fatigue *  1/1 (100.00%)  1
Investigations   
Activated partial thromboplastin time prolonged *  1/1 (100.00%)  1
INR increased *  1/1 (100.00%)  1
Lymphocyte count decreased *  1/1 (100.00%)  1
Neutrophil count decreased *  1/1 (100.00%)  1
Platelet count decreased *  1/1 (100.00%)  1
Weight gain *  1/1 (100.00%)  1
White blood cell decreased *  1/1 (100.00%)  1
Metabolism and nutrition disorders   
Dehydration *  1/1 (100.00%)  1
Hypocalcemia *  1/1 (100.00%)  1
Hypoglycemia *  1/1 (100.00%)  1
Hyponatremia *  1/1 (100.00%)  1
Musculoskeletal and connective tissue disorders   
Pain in extremity *  1/1 (100.00%)  1
Nervous system disorders   
Dizziness *  1/1 (100.00%)  1
Reproductive system and breast disorders   
Vaginal dryness *  1/1 (100.00%)  1
Respiratory, thoracic and mediastinal disorders   
Cough *  1/1 (100.00%)  1
Postnasal drip *  1/1 (100.00%)  1
Vascular disorders   
Hot flashes *  1/1 (100.00%)  1
*
Indicates events were collected by non-systematic assessment
Early termination due to slow accrual. Unable to perform planned analysis due to the small number of subjects.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Paul Frankel, Ph.D.
Organization: City of Hope
Phone: 626-256-4673 ext 65265
Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01320683     History of Changes
Other Study ID Numbers: 09053
NCI-2011-00369 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P01CA043904 ( U.S. NIH Grant/Contract )
First Submitted: March 18, 2011
First Posted: March 22, 2011
Results First Submitted: May 11, 2016
Results First Posted: June 20, 2016
Last Update Posted: July 19, 2016