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

NCT00642603

TerminatedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Colorectal Cancer

Interventions: capecitabine [Xeloda], capecitabine [Xeloda], bevacizumab [Avastin], oxaliplatin, irinotecan

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (76)

PARK Springs, Arizona, United States
Sedona, Arizona, United States
Tucson, Arizona, United States
Anaheim, California, United States
Colton, California, United States
Greenbrae, California, United States
Loma Linda, California, United States
Modesto, California, United States
Montebello, California, United States
Pomona, California, United States
Sacramento, California, United States
Norwich, Connecticut, United States
Waterbury, Connecticut, United States
Lake Worth, Florida, United States
Miami Shores, Florida, United States
New Port Richey, Florida, United States
Ocala, Florida, United States
Ocoee, Florida, United States
Marietta, Georgia, United States
Niles, Illinois, United States
Paducah, Kentucky, United States
Alexandria, Louisiana, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Westminster, Maryland, United States
Pittsfield, Massachusetts, United States
Worcester, Massachusetts, United States
Kalamazoo, Michigan, United States
Duluth, Minnesota, United States
Jefferson City, Missouri, United States
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