Perifosine Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With Refractory Advanced Colorectal Cancer

Completed · Phase 3 · Has a placebo group

Conditions studied: Colorectal Cancer

In brief

The trial will compare the overall survival of perifosine plus capecitabine to placebo plus capecitabine in patients with refractory advanced colorectal cancer.

Key facts

Study ID

NCT01097018

Run by

AEterna Zentaris

People needed

468

Starts

2010-04-01

Expected to finish

2012-04-01

Last updated by the study team

2013-07-02

Who can join

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

You may qualify if…

• Patients must have failed available therapy for the treatment of advanced colorectal cancer, including fluoropyrimidine, irinotecan, oxaliplatin, bevacizumab and for K-ras wild-type (WT) patients, anti-EGFR antibody (cetuximab or panitumumab) containing therapies.
• For oxaliplatin-based therapy, failure of therapy will also include patients who had oxaliplatin discontinued secondary to toxicity.
• No prior exposure to capecitabine in the metastatic colorectal cancer setting, except limited-course radiosensitizing capecitabine
• Patients must have at least one measurable lesion by RECIST criteria

You may not qualify if…

• Patients with known dipyrimidine dehydrogenase (DPD) deficiency or prior severe reaction to 5-FU

Where it is running

• Study site — Bakersfield, California, United States
• Study site — La Verne, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Northridge, California, United States
• Study site — Redondo Beach, California, United States
• Study site — Santa Barbara, California, United States
• Study site — Santa Maria, California, United States
• Study site — Denver, Colorado, United States
• Study site — Grand Junction, Colorado, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Study site — Stamford, Connecticut, United States
• Study site — Waterbury, Connecticut, United States
• Study site — Fort Myers, Florida, United States
• Study site — Hollywood, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — Athens, Georgia, United States
• Study site — Atlanta, Georgia, United States
• Study site — Lawrenceville, Georgia, United States
• Study site — Marietta, Georgia, United States
• Study site — Roswell, Georgia, United States
• Study site — Harvey, Illinois, United States
• Study site — Park Ridge, Illinois, United States
• Study site — South Bend, Indiana, United States
• Study site — Alhambra, California, United States

Full record on ClinicalTrials.gov

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