Phase II Study of the Combination of Bevacizumab (rhuMab VEGF) and Oxaliplatin Plus Capecitabine (XELOX) in Patients With Advanced Colorectal Cancer
Overview
- Phase
- Phase 2
- Intervention
- bevacizumab [Avastin]
- Conditions
- Colorectal Cancer
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 50
- Primary Endpoint
- Percentage of Participants With Objective Response (OR)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
This study will assess the efficacy and safety of treatment with the combination Avastin (bevacizumab) 5mg/kg iv every 2 weeks, Xeloda (capecitabine) 1000 mg po b.i.d. on Days 1-14 of every 28-day cycle and oxaliplatin 40mg/m2 iv weekly in patients with inoperable locally advanced or metastatic colorectal cancer. The anticipated time on study treatment is until disease progression.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult patients \>=18 years of age
- •Locally advanced or metastatic colorectal cancer
- •No previous treatment with chemotherapy for metastatic disease
- •Measurable and/or evaluable lesions
Exclusion Criteria
- •Radiotherapy within 4 weeks before study
- •Untreated brain metastases or primary brain tumors
- •Chronic, daily treatment with high-dose aspirin (\>325mg/day)
- •Co-existing malignancies, or malignancies diagnosed within the last 5 years, with the exception of basal and squamous cell cancer, or cervical cancer in situ
Arms & Interventions
1
Intervention: bevacizumab [Avastin]
1
Intervention: capecitabine [Xeloda]
1
Intervention: oxaliplatin
Outcomes
Primary Outcomes
Percentage of Participants With Objective Response (OR)
Time Frame: Baseline, every 3 months to progression of disease or end of study (up to 24 months)
Percentage of participants with OR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of the longest diameter (LD) diameters of all target lesions. No unequivocal progression of non-target disease. No new lesions. Complete and partial responses must have been confirmed no less than 4 weeks after the criteria for response were first met.
Percentage of Participants by Best Overall Response
Time Frame: Baseline, every 3 months to progression of disease or end of study (up to 24 months)
Best response recorded from the start of treatment until disease progression. Based on assessment of CR, PR, stable disease (SD), or progressive disease (PD), according to RECIST. CR: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: ≥30% decrease under baseline of the sum of the LD diameters of all target lesions. CR and PR persist on repeat imaging study at least 4 weeks after initial documentation. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Reference is the smallest sum LD. PD: at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum longest diameter recorded or the appearance of one or more new lesions.
Secondary Outcomes
- Duration of Stable Disease(Baseline, every 3 months to progression of disease or end of study (up to 24 months))
- Duration of Response(Baseline, every 3 months to progression of disease or end of study (up to 24 months))
- Duration of Stable Disease - Percentage of Participants With an Event by 24 Months(Baseline, every 3 months to progression of disease or end of study (up to 24 months))
- Time to Treatment Failure (TTF) - Percentage of Participants With an Event by 24 Months(Baseline, every month to end of treatment (up to 24 months))
- Time to Treatment Failure(Baseline, monthly to end of study (up to 24 months))
- Time to Progression(Baseline, monthly to end of study (up to 24 months))
- Duration of Response - Percentage of Participants With an Event by 24 Months(Baseline, every 3 months to progression of disease or end of study (up to 24 months))
- Time to Progression (TTP) - Percentage of Participants With an Event by 24 Months(Baseline, monthly to end of study (up to 24 months))
- Overall Survival (OS) - Percentage of Participants With an Event by 24 Months(Baseline, monthly to end of study (up to 24 months))
- Overall Survival(Baseline, monthly to end of study (up to 24 months))