Bevacizumab in Treating Patients Who Have Undergone First-Line Therapy for Metastatic Colorectal Cancer
|ClinicalTrials.gov Identifier: NCT00544700|
Recruitment Status : Terminated (Data collection is completed. As no changes in the endpoints were expected in the future, no further data is needed.)
First Posted : October 16, 2007
Last Update Posted : February 20, 2020
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 or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Biological: bevacizumab Other: no maintenance||Phase 3|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||265 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||November 26, 2007|
|Actual Primary Completion Date :||January 21, 2013|
|Actual Study Completion Date :||December 12, 2019|
Active Comparator: Arm A: Bevacizumab monotherapy
Bevacizumab maintenance monotherapy
7.5 mg/kg i.v. bevacizumab every 21 days until progression or unacceptable toxicity
Other Name: Avastin®
Arm B: No maintenance
No antitumor treatment until progression
Other: no maintenance
No treatment until progression
- Time to progression (TTP) [ Time Frame: 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.
- Overall survival (OS) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00544700
|Study Chair:||Dieter Koeberle, MD||St. Claraspital Basel|
|Study Chair:||Peter Moosmann, MD||Kantonsspital Aarau|