A Study of Bevacizumab (Avastin) in Combination With Capecitabine (Xeloda) in Elderly Patients With Metastatic Colorectal Cancer

Roche

Status and phase: Completed; Phase 3

Conditions: Colorectal Cancer

Treatments: Drug: Capecitabine; Drug: Bevacizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00484939

MO19286

Details and patient eligibility

About

This 2-arm study assessed the efficacy and safety of bevacizumab (Avastin) in combination with capecitabine (Xeloda), compared with capecitabine alone, in elderly patients with metastatic colorectal cancer. Patients were randomized to receive either bevacizumab (7.5 mg/kg intravenously on Day 1 of each 3-week cycle) in combination with capecitabine (1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle) or capecitabine (1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle) alone.

No notable trends or interactions in laboratory values, electrocardiogram, or vital signs suggesting an effect in either direction for capecitabine/bevacizumab combination therapy or capecitabine monotherapy were observed during the study.

Enrollment: 280 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, ≥ 70 years of age.
• Cancer of the colon or rectum.
• Metastatic disease diagnosed ≤ 6 months before enrollment.
• ≥ 1 measurable metastatic lesion.

Exclusion criteria

• Adjuvant anti-vascular endothelial growth factor (VEGF) treatment.
• Prior chemotherapeutic treatment for metastatic colorectal cancer.
• Past or current history of other malignancies (with the exception of basal and squamous cell cancer of the skin, or in situ cancer of the cervix).
• Clinically significant cardiovascular disease.
• Current or recent daily use of aspirin (> 325 mg/day) or other non-steroidal anti-inflammatory drug (NSAID), or full dose anticoagulants.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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280 participants in 2 patient groups

Bevacizumab + capecitabine

Experimental group

Description:

Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m\^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.

Treatment:

Drug: Bevacizumab

Drug: Capecitabine

Capecitabine

Active Comparator group

Description:

Participants received capecitabine 1000 mg/m\^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.

Treatment:

Drug: Capecitabine