2nd-line Treatment of Metastatic Colorectal Cancer (BEVATOMOX)
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|ClinicalTrials.gov Identifier: NCT01532804|
Recruitment Status : Active, not recruiting
First Posted : February 15, 2012
Last Update Posted : August 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Colorectal Cancer||Drug: bevacizumab, oxaliplatin and 5FU combination Drug: Bevacizumab, oxaliplatin and raltitrexed combination||Phase 2|
Eligible patients are randomly allocated to receive either bevacizumab with raltitrexed and oxaliplatin combination or bevacizumab with FOLFOX 6 combination. Random allocation schedule is performed using a minimization technique for the following stratification factors:
- Number of metastatic sites: 1 versus > 1
- Bevacizumab-based first-line therapy: Yes versus No
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||83 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Randomized Phase 2 Trial to Evaluate the Triplet Combination of Raltitrexed, Oxaliplatin and Bevacizumab Versus FOLFOX6 Plus Bevacizumab in Second-line Treatment of Metastatic Colorectal Cancer|
|Study Start Date :||July 2011|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Arm A
FOLFOX6 + bevacizumab (D1=D15, 12 cycles)
Drug: bevacizumab, oxaliplatin and 5FU combination
Bevacizumab 5 mg/kg administered as an iv infusion for 1h30, then for 1h and for 30 min. at the following cycles, respectively.
Oxaliplatin 85 mg/m² administered as an iv infusion for 2h Elvorine 200 mg/m² administered as an iv infusion for 2h 5FU 400 mg/m2 bolus then 5FU 2,400 mg/m² iv infusion for 46h D1=D15 (12 cycles)
Experimental: Arm B
Raltitrexed + Oxaliplatin + Bevacizumab (D1=D21, 8 cycles)
Drug: Bevacizumab, oxaliplatin and raltitrexed combination
Bevacizumab 7.5 mg/kg administered as an iv infusion for 1h30, then administered for 1h and 30 min at the following cycles, respectively.
Oxaliplatin 130 mg/m² administered as an iv infusion for 2h Raltitrexed 3 mg/m² administered as an iv infusion for 15 min
- Disease-free survival [ Time Frame: 6 months ]DFS is estimated from the date of randomization until the first date of objectively documented event or death
- Treatment-related toxicity [ Time Frame: 6 months ]Treatment-related toxicity is evaluated according to the NCI-CTCAE v.4 criteria.
- Objective response rate [ Time Frame: Every 9 weeks ]Objective response rate is evaluated according to the RECIST V 1.1 criteria.
- Overall survival [ Time Frame: unk ]OS is estimated from the date of randomization until the date of death from any cause
- Cost-effectiveness study [ Time Frame: 6 months ]The cost-effectiveness study includes the number of hospital stays (treatment and toxicity), the global cost of treatments, and the cost of hospital stays due to treatment-induced toxicity
- Quality of life [ Time Frame: 6 months ]Quality of life is measured using the QLQ-C30 questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01532804
|Val d'Aurelle Cancer Institute|
|Montpellier, France, 34298|
|Principal Investigator:||Emmanuelle Samalin-Scalzi, MD||Val d'Aurelle Cancer Institute|