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Sponsors and Collaborators: |
Dutch Colorectal Cancer Group Koningin Wilhelmina Fonds (Dutch Cancer Fund) Sanofi-Aventis Hoffmann-La Roche |
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Information provided by: | Dutch Colorectal Cancer Group |
ClinicalTrials.gov Identifier: | NCT00442637 |
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 | Intervention | Phase |
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Advanced Colorectal Cancer |
Drug: capecitabine + bevacizumab Other: observation |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 635 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
observation
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Other: observation
observation after induction treatment
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2: Active Comparator
capecitabine plus bevacizumab
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Drug: capecitabine + bevacizumab
Ca 1250 mg/m2 daily orally continuously, B 7.5 mg/kg i.v. q 3 w
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Before the start of induction therapy:
Inclusion Criteria:
Exclusion criteria
At randomisation:
Inclusion criteria:
Contact: Miriam Koopman, MD | +31 243610353 | rsc@rsconsultancy.nl |
Contact: C. Punt, MD PhD | +31 243610353 | rsc@rsconsultancy.nl |
Netherlands, Gelderland | |
University Medical Center Nijmegen | Recruiting |
Nijmegen, Gelderland, Netherlands | |
Contact: C JA Punt, MD PhD C.Punt@onco.umcn.nl |
Principal Investigator: | C. JA Punt, MD PhD | University Medical Centre Nijmegen Netherlands |
Responsible Party: | DCCG ( Prof. Dr. C.J.A. Punt ) |
Study ID Numbers: | CAIRO3 |
Study First Received: | February 28, 2007 |
Last Updated: | September 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00442637 History of Changes |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
CAIRO3 DCCG colorectal cancer induction metronomic chemotherapy |
observation capecitabine bevacizumab oxaliplatin |
Antimetabolites Capecitabine Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Bevacizumab Intestinal Diseases Angiogenesis Inhibitors |
Rectal Diseases Intestinal Neoplasms Carcinoma Oxaliplatin Digestive System Diseases Gastrointestinal Neoplasms Colorectal Neoplasms |
Antimetabolites Capecitabine Antimetabolites, Antineoplastic Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Growth Substances Physiological Effects of Drugs Colonic Diseases Bevacizumab Intestinal Diseases |
Angiogenesis Inhibitors Rectal Diseases Pharmacologic Actions Intestinal Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Growth Inhibitors Angiogenesis Modulating Agents Colorectal Neoplasms |