Maintenance Treatment Versus Observation After Induction in Advanced Colorectal Carcinoma (CAIRO3)
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|ClinicalTrials.gov Identifier: NCT00442637|
Recruitment Status : Unknown
Verified December 2013 by Dutch Colorectal Cancer Group.
Recruitment status was: Active, not recruiting
First Posted : March 2, 2007
Last Update Posted : December 12, 2013
The optimal duration of systemic treatment in patients with advanced colorectal cancer is unknown.
In this study the effects of bevacizumab and low-dose continuous chemotherapy with capecitabine is investigated in patients who have responded to 6 courses of oxaliplatin, capecitabine and bevacizumab ("induction treatment", at standard doses). This treatment is continued until progression or severe toxicity. This regimen is compared to the effects a observation without treatment after the induction treatment.
In case of disease progression, induction treatment will be reintroduced.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Metastatic||Drug: capecitabine + bevacizumab Other: observation||Phase 3|
Standard 1st-line treatment for patients with advanced colorectal cancer currently consists of chemotherapy plus bevacizumab. With this approach the median overall survival is approximately 20 months, and progression-free survival in first-line approximately 9-11 months. The optimal duration of treatment is unknown. Current data suggest that the efficacy of bevacizumab is dependent on concomitant use of chemotherapy. However, oxaliplatin almost invariably gives rise to neuropathy after 6-8 cycles. Prolonged use of capecitabine is associated with e.g. hand-foot syndrome. Lastly, the prolonged use of these agents is associated with considerable costs.
Evidence, mainly preclinical, suggests that continuous dosing metronomic chemotherapy may be more efficacious than interval-chemotherapy given at MTD. In this study the concept of metronomic chemotherapy is explored by administering a continuous daily instead of the usual 2 weeks-on/1 week-off oral dosing regimen of low-dose capecitabine plus bevacizumab as maintenance therapy after induction combination chemotherapy given at MTD plus bevacizumab.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||635 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Maintenance Treatment With Capecitabine and Bevacizumab Versus Observation After Induction Treatment With Chemotherapy and Bevacizumab as First-line Treatment in Patients With Advanced Colorectal Carcinoma|
|Study Start Date :||January 2007|
|Primary Completion Date :||September 2013|
|Estimated Study Completion Date :||December 2013|
observation after induction treatment
Active Comparator: 2
capecitabine plus bevacizumab
Drug: capecitabine + bevacizumab
Ca 1250 mg/m2 daily orally continuously, B 7.5 mg/kg i.v. q 3 w
- Progression-free survival after re-introduction of MTD chemotherapy and bevacizumab (PFS2) [ Time Frame: study duration ]
- Progression-free survival between observation versus maintenance therapy (PFS1) [ Time Frame: study duration ]
- Response rate during re-introduction of MTD chemotherapy and bevacizumab [ Time Frame: study duration ]
- Toxicity [ Time Frame: study duration ]
- Quality of life [ Time Frame: study duration ]
- Overall survival [ Time Frame: study duration ]
- Translational research [ Time Frame: study duration ]
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): NCT00442637
|University Medical Center Nijmegen|
|Nijmegen, Gelderland, Netherlands|
|Principal Investigator:||C. JA Punt, MD PhD||Amsterdam Medical Centre, Amsterdam Netherlands|