A Study of Avastin (Bevacizumab) and Oxaliplatin Plus Xeloda (Capecitabine) in Patients With Advanced Colorectal Cancer.
- Conditions
- Colorectal Cancer
- Interventions
- Registration Number
- NCT01159171
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 bevacizumab [Avastin] - 1 capecitabine [Xeloda] - 1 oxaliplatin -
- Primary Outcome Measures
Name Time Method Percentage of Participants With Objective Response (OR) 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 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 Outcome Measures
Name Time Method Duration of Stable Disease Baseline, every 3 months to progression of disease or end of study (up to 24 months) Duration of stable response (CR, PR, or SD) was calculated only for participants of the ITT population whose best overall response was CR, PR, or SD based on RECIST criteria. Duration of overall response was defined as the time from the date of the first assessment of CR, PR, or SD status until the date of progression or death. Data for participants who were alive without any objectively documented disease progression at the end of the study were censored as of the date of last contact. Mean time to event was estimated using the Kaplan-Meier method.
Duration of Response Baseline, every 3 months to progression of disease or end of study (up to 24 months) Duration of overall response (CR or PR) was calculated for participants of the ITT population whose best overall response was CR or PR based on RECIST criteria. Duration of overall response was defined as the time from the date of the first assessment of CR or PR status until the date of progression or death. Data for participants who were alive without any objectively documented disease progression at the end of the study were censored as of the date of last contact. Mean time to event was estimated using the Kaplan-Meier method.
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) Duration of stable response (CR, PR, or stable disease \[SD\]) was calculated only for participants of the ITT population whose best overall response was CR, PR, or SD based on RECIST criteria. Duration of overall response was defined as the time from the date of the first assessment of CR, PR, or SD status until the date of progression or death. Data for participants who were alive without any objectively documented disease progression at the end of the study were censored as of the date of last contact.
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) TTF was defined as the time in months from Day 1 until discontinuation of treatment for any reasons. These reasons included: death due to any cause, treatment toxicity (adverse event), insufficient therapeutic response (progression of disease), failure to return (lost to follow-up), refusing treatment (participant non-compliance), being unwilling to cooperate and withdrawing consent (participant withdrew consent).
Time to Treatment Failure Baseline, monthly to end of study (up to 24 months) TTF was defined as the time in months from Day 1 until discontinuation of treatment for any reasons. These reasons included: death due to any cause, treatment toxicity (adverse event), insufficient therapeutic response (progression of disease), failure to return (lost to follow-up), refusing treatment (participant non-compliance), being unwilling to cooperate and withdrawing consent (participant withdrew consent). Mean TTF was estimated using the Kaplan-Meier method.
Time to Progression Baseline, monthly to end of study (up to 24 months) TTP was defined as the time in months from Day 1 until the date of first documented progressive disease, or death due to any cause. Data for participants who were alive without disease progression at the end of study, or who were non-responder participants (without tumor assessment after baseline) were censored at Day 1. Mean TTP was estimated using the Kaplan-Meier method.
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) Duration of overall response (CR or PR) was calculated only for participants of the ITT population whose best overall response was CR or PR based on RECIST criteria. Duration of overall response was defined as the time from the date of the first assessment of CR or PR status until the date of progression or death. Data for participants who were alive without any objectively documented disease progression at the end of the study were censored as of the date of last contact.
Time to Progression (TTP) - Percentage of Participants With an Event by 24 Months Baseline, monthly to end of study (up to 24 months) TTP was defined as the time time in months from Day 1 until the date of first documented progressive disease, or death due to any cause. Data for participants who were alive without disease progression at the end of study, or who were non-responder participants (without tumor assessment after baseline) were censored at Day 1.
Overall Survival (OS) - Percentage of Participants With an Event by 24 Months Baseline, monthly to end of study (up to 24 months) OS was defined as the time in months from Day 1 until the date of death due to any cause. Data for participants who were alive at the end of the study were censored at the date of the last available follow-up visit.
Overall Survival Baseline, monthly to end of study (up to 24 months) OS was defined as the time in months from Day 1 until the date of death due to any cause. Data for participants who were alive at the end of the study were censored at the date of the last available follow-up visit. Mean OS was estimated using the Kaplan-Meier method.