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Sponsored by: |
British Columbia Cancer Agency |
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Information provided by: | British Columbia Cancer Agency |
ClinicalTrials.gov Identifier: | NCT00386828 |
This phase II study will evaluate the effect of bevacizumab, capecitabine and oxaliplatin with radiation on rectal cancer. Researchers will also evaluate the tolerability (how it makes the patient feel) and safety of this combination by watching for harmful side-effects.It is hoped that by adding bevacizumab to the capecitabine/oxaliplatin treatment in combination with radiation before surgery will improve response rate.
Condition | Intervention | Phase |
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Advanced Colorectal Cancer |
Drug: Bevacizumab: |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of Chemoradiation for Locally Advanced and Low Rectal Cancers: Avastin-Capecitabine-Oxaliplatin-Radiation REctal Cancer Trial |
Estimated Enrollment: | 55 |
Study Start Date: | October 2006 |
Improved pre-operative therapy is required in the management of high risk rectal cancer in order to decrease local recurrence and increase the rate of sphincter sparing surgery. Capecitabine, oxaliplatin and bevacizumab represent new systemic agents and have been given safely in phase I and II trials concurrently with radiation with promising improvements in pCR rates of 15 -24% compared to historic rates of 8-14% achieved with 5-FU alone. Improvements in pCR rates have not been associated with an increase in post-operative complication rates. A trial of all three of these agents is justified due to their enhanced efficacy when given in combination as well as their non-overlapping treatment toxicity profile.
This is a one-armed, multi-centred, Phase II study in patients with T3/4 locally advanced and T3/4 low lying rectal cancer, to study the efficacy and safety of the addition of bevacizumab to a regimen of capecitabine and oxaliplatin in combination with pre-operative radiation.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Mid- or upper rectal tumours (>= 6 - 15 cm): T3 or T4 adenocarcinoma that is fixed or partially fixed or tethered and is potentially resectable; or Low rectal tumours (<6cm): T3 or T4 adenocarcinoma: or Node positive rectal tumours (<= 15cm): T1-4N2 or T1-4N+ where pelvic nodes approach or invade the mesorectum.
ANC >=1.5 platelets >=100 Serum creatinine <= 1.5X ULN AST, ALT <= 2.5X ULN Bilirubin <= 1.5 ULN PTT and INR within normal limits Albumin >= than 30
Exclusion Criteria:
cerebrovascular accidents (<=6 months), myocardial infarction (<= 6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication.
Contact: Hagen Kennecke, MD | 604-8776000 | hkenneck@bccancer.bc.ca |
Canada, British Columbia | |
BC Cancer Agency - Vancouver Centre | Recruiting |
Vancouver, British Columbia, Canada, V5Z 4E6 | |
Contact: Cathy Paul, Nursing 604-877-6000 ext 2816 cpaul@bccancer.bc.ca |
Study Chair: | Hagen Kennecke, MD | BC Cancer Agency -Vancouver Centre |
Responsible Party: | BC Cancer Agency - Vancouver Centre ( Dr Hagen Kennecke ) |
Study ID Numbers: | PROTOCOL NUMBER: OZM-004, A-CORRECT Study |
Study First Received: | October 11, 2006 |
Last Updated: | November 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00386828 |
Health Authority: | Canada: Health Canada |
colorectal cancer advanced colorectal cancer |
Capecitabine Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Bevacizumab Intestinal Diseases Rectal Diseases |
Intestinal Neoplasms Rectal neoplasm Oxaliplatin Digestive System Diseases Gastrointestinal Neoplasms Rectal cancer Colorectal Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |