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Sponsored by: |
Swiss Group for Clinical Cancer Research |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00544700 |
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether giving bevacizumab as maintenance therapy is more effective than observation in treating patients with colorectal cancer.
PURPOSE: This randomized phase III trial is studying bevacizumab to see how well it works in treating patients who have undergone first-line therapy for metastatic colorectal cancer.
Condition | Intervention | Phase |
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Colorectal Cancer |
Biological: bevacizumab Procedure: adjuvant therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | Bevacizumab Maintenance Versus no Maintenance After Stop of First-Line Chemotherapy in Patients With Metastatic Colorectal Cancer. A Randomized Multicenter Phase III Non-Inferiority Trial |
Estimated Enrollment: | 238 |
Study Start Date: | October 2007 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to best response during first-line chemotherapy/bevacizumab treatment (complete response and partial response vs stable disease), duration of first-line treatment (16-20 weeks vs 21-24 weeks), type of chemotherapy used during first-line treatment (irinotecan and fluoropyrimidine vs oxaliplatin and fluoropyrimidine vs fluoropyrimidine monotherapy), disease burden (one organ with metastasis vs more than one organ with metastasis), and by participating center.
After completion of study therapy or documentation of disease progression, patients are followed every 3 months for 1 year and then every 6 months for up to 5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Received prior first-line chemotherapy with oral or intravenous fluoropyrimidine alone or in combination with irinotecan or oxaliplatin
No clinical symptoms or history of CNS metastases
PATIENT CHARACTERISTICS:
No medical reason that prohibits further bevacizumab treatment, including any of the following:
PRIOR CONCURRENT THERAPY:
No concurrent daily aspirin exceeding 325 mg/day or clopidogrel exceeding 75 mg/day
Switzerland | |
Kantonspital Aarau | Recruiting |
Aarau, Switzerland, CH-5000 | |
Contact: Peter Moosmann, MD, PhD 41-62-838-6051 peter.moosmann@ksa.ch | |
Kantonsspital - St. Gallen | Recruiting |
St. Gallen, Switzerland, CH-9007 | |
Contact: Dieter Koeberle, MD 41-71-494-1111 dieter.koeberle@kssg.ch |
Study Chair: | Dieter Koeberle, MD | Kantonsspital - St. Gallen |
Investigator: | Peter Moosmann, MD, PhD | Kantonspital Aarau |
Study ID Numbers: | CDR0000569866, SWS-SAKK-41/06, EU-20762 |
Study First Received: | October 13, 2007 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00544700 History of Changes |
Health Authority: | Unspecified |
stage IV colon cancer stage IV rectal cancer |
Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Adjuvants, Immunologic Rectal Neoplasm Bevacizumab Intestinal Diseases |
Angiogenesis Inhibitors Rectal Diseases Intestinal Neoplasms Digestive System Diseases Rectal Cancer Gastrointestinal Neoplasms Colorectal Neoplasms |
Digestive System Neoplasms Antineoplastic Agents Gastrointestinal Diseases Growth Substances Physiological Effects of Drugs Colonic Diseases Bevacizumab Intestinal Diseases Rectal Diseases Angiogenesis Inhibitors |
Pharmacologic Actions Intestinal Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Growth Inhibitors Angiogenesis Modulating Agents Colorectal Neoplasms |