Bevacizumab in Treating Patients Who Have Undergone First-Line Therapy for Metastatic Colorectal Cancer
- Conditions
- Colorectal Cancer
- Interventions
- Other: no maintenanceBiological: bevacizumab
- Registration Number
- NCT00544700
- Lead Sponsor
- Swiss Group for Clinical Cancer Research
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
Primary
* To demonstrate that time to progression (TTP) without further treatment is not inferior to TTP with maintenance therapy comprising bevacizumab in patients with metastatic colorectal cancer and stable or responding disease after completion of standard first-line chemotherapy/bevacizumab treatment.
Secondary
* To evaluate the safety of bevacizumab maintenance therapy in these patients.
* To assess the long-term cost implications of prolonged treatment with bevacizumab.
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.
* Arm I (bevacizumab maintenance therapy): Patients receive bevacizumab IV over 30 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
* Arm II (no maintenance therapy): Patients receive no further treatment; they are monitored for disease progression.
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 265
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B: No maintenance no maintenance No antitumor treatment until progression Arm A: Bevacizumab monotherapy bevacizumab Bevacizumab maintenance monotherapy
- Primary Outcome Measures
Name Time Method Time to progression (TTP) From randomization until documented progressive disease or death due to tumor. TTP will be calculated from randomization until documented PD or death due to tumor.
- Secondary Outcome Measures
Name Time Method Overall survival (OS) OS will be calculated from start of first-line treatment until death. Additionally, OS will be calculated from randomization until death. OS will be calculated from start of first-line treatment until death. Additionally, OS will be calculated from randomization until death.
Progression-free survival (PFS) From start of first-line treatment until documented PD or death, whichever occurs first. PFS will be calculated from start of first-line treatment until documented PD or death, whichever occurs first. Additionally, PFS will be calculated from randomization until documented PD or death, whichever occurs first.
Adverse events (AE) Predefined AEs and AEs ≥ grade 3 will be assessed according to NCI CTCAE v3.0. Predefined AEs and AEs ≥ grade 3 will be assessed according to NCI CTCAE v3.0.
Long-term bevacizumab treatment costs Estimated for the time period between randomization and the end of the follow-up phase (lasting maximal 5 years). Costs of bevacizumab treatment, including additional treatments and/or hospitalisations related to bevacizumab, as well as other anticancer treatments and their related hospitalisations, will be estimated for the time period between randomization and the end of the follow-up phase (lasting maximal 5 years) from information collected on the CRFs during trial treatment and follow-up phase.
Trial Locations
- Locations (29)
Universitaetsspital-Basel
🇨🇭Basel, Switzerland
Inselspital, Bern
🇨🇭Bern, Switzerland
Kantonsspital Bruderholz
🇨🇭Bruderholz, Switzerland
Spital Buelach
🇨🇭Bulach, Switzerland
Kantonsspital Graubuenden
🇨🇭Chur, Switzerland
Hopital Cantonal Universitaire de Geneve
🇨🇭Geneva, Switzerland
Hopital Fribourgeois
🇨🇭Fribourg, Switzerland
Centre Hospitalier Universitaire Vaudois
🇨🇭Lausanne, Switzerland
Kantonsspital Liestal
🇨🇭Liestal, Switzerland
Onkologie Zentrum am Spital Maennedorf
🇨🇭Männedorf, Switzerland
Kantonsspital Olten
🇨🇭Olten, Switzerland
Kantonsspital - St. Gallen
🇨🇭St. Gallen, Switzerland
Hopital Regional de Sion-Herens-Conthey
🇨🇭Sion, Switzerland
Regionalspital
🇨🇭Thun, Switzerland
Spital Uster
🇨🇭Uster, Switzerland
Onkozentrum Klinik im Park
🇨🇭Zurich, Switzerland
Kantonsspital Winterthur
🇨🇭Winterthur, Switzerland
Klinik Hirslanden
🇨🇭Zurich, Switzerland
Kantonsspital Aarau
🇨🇭Aarau, Switzerland
Kantonsspital Baden
🇨🇭Baden, Switzerland
St. Claraspital AG
🇨🇭Basel, Switzerland
AndreasKlinik Cham Zug
🇨🇭Cham, Switzerland
Stadtspital Waid
🇨🇭Zurich, Switzerland
Spitalzentrum Biel
🇨🇭Biel, Switzerland
Hirslanden Klinik Aarau
🇨🇭Aarau, Switzerland
Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
🇨🇭Bellinzona, Switzerland
Istituto Oncologico della Svizzera Italiana
🇨🇭Lugano, Switzerland
Kantonsspital Luzern
🇨🇭Luzerne, Switzerland
UniversitaetsSpital Zuerich
🇨🇭Zurich, Switzerland