A Phase II Trial to Evaluate the Efficacy and Safety of Bevacizumab in Combination With Capecitabine (Xeloda) in Frail Patients With Untreated Metastatic Colorectal Cancer
Overview
- Phase
- Phase 2
- Intervention
- Capecitabine (Xeloda)
- Conditions
- Colorectal Cancer
- Sponsor
- Translational Oncology Research International
- Enrollment
- 45
- Locations
- 12
- Primary Endpoint
- Time to Disease Progression
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of the bevacizumab and capecitabine combination in frail patients with untreated metastatic colorectal cancer.
Detailed Description
The study will evaluate the tolerability, safety, and feasibility of combination bevacizumab and capecitabine in a small number of frail patients with metastatic colorectal cancer who have a compromised performance status. Preclinical studies suggest that the combination of chemotherapy and anti-angiogenic therapy offer an increased anti-tumor effect compared with either treatment alone.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically or cytologically proven adenocarcinoma of the colon at first diagnosis
- •Stage IV disease, with at least one measurable lesion according to the RECIST criteria
- •Eastern Cooperative Oncology Group (ECOG) performance status 2
- •No prior chemotherapy for metastatic colorectal cancer
- •Prior adjuvant chemotherapy is permitted.
- •At least 28 days since prior surgery
- •If female of childbearing potential, pregnancy test is negative and willing to use effective contraception while on treatment and for at least 3 months thereafter.
- •Required laboratory values:
- •Absolute neutrophil count \> 1.5 x 10\^9/L
- •Hemoglobin \> 9.0 g/dL
Exclusion Criteria
- •Prior chemotherapy for metastatic colorectal cancer
- •Prior treatment with an anti-angiogenic agent
- •Concurrent therapy with any other non-protocol anti-cancer therapy
- •Current or prior history of central nervous system or brain metastases
- •Presence of neuropathy \> grade 2 (NCI-Common Toxicity Criteria (CTC) version 3.0) at baseline
- •Presence of any non-healing wound, fracture, or ulcer, or the presence of clinically significant (\> grade 2) peripheral vascular disease
- •History of any other malignancy within the past 5 years, with the exception of non-melanoma skin cancer or carcinoma-in-situ of the cervix
- •Clinically significant cardiovascular disease (e.g., blood pressure \[BP\] \> 150/100, myocardial infarction or stroke within the past 6 months, unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
- •Active peptic ulcer disease, inflammatory bowel disease, or other gastrointestinal condition increasing the risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning therapy
- •Active infection requiring parenteral antimicrobials
Arms & Interventions
Bevacizumab Plus Capecitabine
Bevacizumab 7.5 mg/kg every 3 weeks will be administered interavenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m\^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.
Intervention: Capecitabine (Xeloda)
Bevacizumab Plus Capecitabine
Bevacizumab 7.5 mg/kg every 3 weeks will be administered interavenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m\^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.
Intervention: Bevacizumab
Outcomes
Primary Outcomes
Time to Disease Progression
Time Frame: 12 months
Progression Free Survival (PFS)- the interval from the date of enrollment to the first documented date of disease progression, death due to cancer, or the last date of a definitive assessment (not an unknown assessment) at which the patient is known to be progression-free. If there is an unknown assessment, then (a) if the next subsequent definitive assessment is complete response (CR), partial response (PR), or stable disease (SD), the patient is considered to be progression-free at the date of the subsequent definitive assessment and PFS is calculated as above; (b) if the next subsequent definitive assessment is progressive disease (PD), the patient is considered to be a failure at the time of the (earliest) assessment of unknown preceding the documented disease progression (i.e. PFS is back-dated to the date of the unknown assessment) and (c) if there is no subsequent definitive assessment, PFS for the patient is considered to be a censored observation at the date
Number of Subjects Requiring Dose Modifications
Time Frame: 3 months
Number of Subjects that required Bevacizumab or Capecitabine dose modifications, delay, reduction or discontinuation due to adverse reactions.
Secondary Outcomes
- Response Rates(every 21 days up to 12 months)
- Quality of Life of Patients(Baseline, Cycle 2, and End of Study)