This trial is active, not recruiting.

Condition colorectal cancer
Treatments bevacizumab, no maintenance
Phase phase 3
Target VEGF
Sponsor Swiss Group for Clinical Cancer Research
Start date October 2007
End date May 2012
Trial size 265 participants
Trial identifier NCT00544700, CDR0000569866, EU-20762, SAKK 41/06, SWS-SAKK-41/06


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Bevacizumab maintenance monotherapy
bevacizumab Avastin®
7.5 mg/kg i.v. bevacizumab every 21 days until progression or unacceptable toxicity
No antitumor treatment until progression
no maintenance
No treatment until progression

Primary Outcomes

Time to progression
time frame: From randomization until documented progressive disease or death due to tumor.

Secondary Outcomes

Overall survival
time frame: 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.
Adverse events (AE)
time frame: 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).

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed metastatic colorectal cancer - Received prior first-line chemotherapy with oral or intravenous fluoropyrimidine alone or in combination with irinotecan or oxaliplatin - Chemotherapy must have been given in combination with a standard dose of bevacizumab for 16-24 weeks as part of first-line treatment for metastatic colorectal cancer - Stable disease, partial response, or complete response after completion of first-line treatment as documented by abdominal and thoracic CT scan, MRI, or x-ray within the past 21 days - No clinical symptoms or history of CNS metastases - No imaging required in asymptomatic patients PATIENT CHARACTERISTICS: - WHO performance status 0-1 - Serum creatinine < 2.0 mg/dL or 177 μmol/L - Proteinuria < 2+ by urine dipstick OR urine protein ≤ 1 g by 24-hour urine collection - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 12 months after completion of study therapy - Must have basic health insurance with a Swiss health insurance company - Patients must be compliant and in geographic proximity to allow proper staging and follow-up - No medical reason that prohibits further bevacizumab treatment, including any of the following: - Uncontrolled hypertension (systolic blood pressure [BP] > 150 mm Hg and/or diastolic BP > 100 mm Hg) or clinically significant (i.e., active) cardiovascular disease - Serious non-healing wound, active peptic ulcer, or non-healing bone fracture - History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months - History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding - No serious underlying medical condition that, in the judgment of the investigator, could further impair the ability of the patient to participate in the trial (e.g., active autoimmune disease or uncontrolled diabetes) - No psychiatric disorder that would preclude patient understanding of study-related topics or giving informed consent PRIOR CONCURRENT THERAPY: - See Disease Characteristics - At least 4 weeks since prior bevacizumab - No prior anti-EGFR treatment (e.g., cetuximab) during first-line therapy - No anticipation of concurrent major surgery (e.g., resection) or ablation of metastases - No concurrent elective major surgery - No concurrent daily aspirin exceeding 325 mg/day or clopidogrel exceeding 75 mg/day - Lower doses of the drugs noted above, or non-steroidal anti-inflammatory drugs with activity on platelets and gastric mucosa, or dipyridamole are allowed if given at a stable dose for ≥ 2 weeks prior to study entry - No other concurrent experimental drugs or anticancer therapy

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Swiss Group for Clinical Cancer Research.