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OpenTrials
Terminated

NCT Number: NCT00642603

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

PARK Springs, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

capecitabine [Xeloda]

Drug

1000 mg/m2 twice-daily, taken orally on Days 1-7 of each 2 week cycle

bevacizumab [Avastin]

Drug

5 mg/kg taken intravenously on Day 1 of each 2 week cycle

Oxaliplatin

Drug

85 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles

Irinotecan

Drug

135 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles

Primary outcomes

  1. Progression-free Survival (PFS) in U.S. Patients Only

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Randomized, Open Label Study of the Effect of First Line Treatment With Xeloda in Combination With Avastin and Either Short Course Irinotecan or Short Course Oxaliplatin on Progression-free Survival in Patients With Metastatic Colorectal Cancer

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 25, 2008
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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