A Study of Xeloda (Capecitabine) in Combination With Avastin + Short Course Chemotherapy in Patients With Metastatic Colorectal Cancer

Phase 2

Terminated

• Conditions: Colorectal Cancer
• Interventions: Drug: capecitabine [Xeloda]; Drug: bevacizumab [Avastin]; Drug: oxaliplatin; Drug: irinotecan

• Registration Number: NCT00642603
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This 2-arm study was designed to evaluate the efficacy and safety of 2 treatment regimens of Xeloda and Avastin, with either irinotecan or oxaliplatin administered for the first 12 cycles, as first line treatment in patients with metastatic colorectal cancer. Patients were randomized to receive 2-weekly cycles of treatment with either: 1) Xeloda, Avastin and oxaliplatin; or 2) Xeloda, Avastin and irinotecan. After 9 cycles, patients continued to receive maintenance treatment with Xeloda + Avastin. The anticipated time on study treatment was until disease progression, and the target sample size was 100-500 individuals.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2008-03-19
• Study First Submitted QC: 2008-03-19
• Study First Posted: 2008-03-25
• Study Start: 2008-05
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Results First Submitted: 2010-06-10
• Results First Submitted QC: 2011-05-31
• Results First Posted: 2011-06-23
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-28
• Last Update Posted: 2018-03-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• Adult patients, ≥18 years of age
• Histologically confirmed adenocarcinoma of colon or rectum, with unresectable metastatic or locally advanced disease
• ≥1 measurable target lesion
• Ambulatory, with an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1

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Exclusion Criteria

• Prior systemic therapy for advanced or metastatic disease
• History of another malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of the cervix
• Clinically significant cardiovascular disease
• Current or recent use of full dose oral warfarin or full dose parenteral anticoagulants or thrombolytic agents
• Chronic daily treatment with >325 mg/day aspirin

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
XELOX + bevacizumab (Q2W)	bevacizumab [Avastin]	-
XELOX + bevacizumab (Q2W)	capecitabine [Xeloda]	-
XELIRI + bevacizumab (Q2W)	capecitabine [Xeloda]	-
XELIRI + bevacizumab (Q2W)	bevacizumab [Avastin]	-
XELOX + bevacizumab (Q2W)	oxaliplatin	-
XELIRI + bevacizumab (Q2W)	irinotecan	-

Primary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS) in U.S. Patients Only	From first patient enrolled up to approximately 48 months	PFS was defined as the time from the date of randomization to the first documented occurrence of disease progression or death due to any cause.