A Study of Capecitabine (Xeloda) and Bevacizumab as a First-line Therapy in Patients With Metastatic Colorectal Cancer

Completed · Phase 3 · Has a placebo group

Conditions studied: Colorectal Cancer

In brief

This 4 arm study assessed the efficacy and safety of oral capecitabine (Xeloda) or intravenous (iv) fluorouracil/leucovorin, in combination with iv oxaliplatin (Eloxatin) with or without iv bevacizumab (Avastin), as a first-line treatment in patients with metastatic colorectal cancer. Patients were randomized to receive 1) XELOX (Xeloda 1000 mg/m\^2 orally \[po\] twice a day \[bid\] on Days 1-15 + oxaliplatin in 3 week cycles), 2) FOLFOX-4 (oxaliplatin + leucovorin + fluorouracil \[5-FU\] in 2 week cycles), 3) XELOX + bevacizumab (7.5 mg iv on Day 1 in 3 week cycles), or 4) FOLFOX-4 + bevacizumab (5 mg iv on Day 1 in 2 week cycles).

Key facts

Study ID

NCT00069095

Run by

Hoffmann-La Roche

People needed

2035

Starts

2003-07-01

Expected to finish

2009-04-01

Last updated by the study team

2016-10-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients ≥ 18 years of age.
• Metastatic colorectal cancer.
• ≥ 1 target lesion.

You may not qualify if…

• Previous treatment with oxaliplatin or bevacizumab.
• Previous systemic chemotherapy or immunotherapy for advanced or metastatic disease.
• Progressive disease during or within 6 months of completion of previous adjuvant therapy.

Where it is running

• Study site — Fountain Valley, California, United States
• Study site — Fullerton, California, United States
• Study site — Gilroy, California, United States
• Study site — Greenbrae, California, United States
• Study site — Los Angeles, California, United States
• Study site — Orange, California, United States
• Study site — Palo Alto, California, United States
• Study site — San Diego, California, United States
• Study site — Norwich, Connecticut, United States
• Study site — Waterbury, Connecticut, United States
• Study site — Boca Raton, Florida, United States
• Study site — Gainesville, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — New Port Richey, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Elk Grove Village, Illinois, United States
• Study site — Peoria, Illinois, United States
• Study site — Lexington, Kentucky, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Scarborough, Maine, United States
• Study site — Boston, Massachusetts, United States
• Study site — Berkeley, California, United States

Full record on ClinicalTrials.gov

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