A Phase III Randomized Study to Assess the Efficacy and Safety of Perifosine Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With Refractory Advanced Colorectal Cancer
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer
Both
Colorectal Cancer
Trial Information
A Phase III Randomized Study to Assess the Efficacy and Safety of Perifosine Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With Refractory Advanced Colorectal Cancer
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients with known dipyrimidine dehydrogenase (DPD) deficiency or prior severe
reaction to 5-FU
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Overall Survival
Outcome Time Frame:
Monthly
Safety Issue:
No
Principal Investigator
Johanna Bendell, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Sarah Cannon Research Institute
Authority:
United States: Food and Drug Administration
Study ID:
Protocol 343
NCT ID:
NCT01097018
Start Date:
April 2010
Completion Date:
April 2012
Related Keywords:
- Colorectal Cancer
- Colorectal Neoplasms
Name | Location |
|---|---|
| Hinsdale, Illinois 60521 | |
| New Britain, Connecticut 06052 | |
| Albany, Georgia 31701 | |
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Columbia, Missouri 65203 | |
| Albany, New York 12208 | |
| Cleveland, Ohio 44195 | |
| Nashville, Tennessee 37203-1632 | |
| Austin, Texas 78705 | |
| Seattle, Washington 98195 | |
| Flint, Michigan 48532 | |
| McLean, Virginia 22101 | |
| Omaha, Nebraska 68114 | |
| Hackensack, New Jersey 07601 | |
| Albuquerque, New Mexico 87131-5636 | |
| Denver, Colorado | |
| Baltimore, Maryland 21287 | |
| Charlotte, North Carolina | |
| Indianapolis, Indiana | |
| Charleston, South Carolina | |
| Tulsa, Oklahoma | |
| Las Vegas, Nevada 89109 | |
| Jackson, Mississippi | |
| Yale University School Of Medicine | New Haven, Connecticut 06520 |
| Bismarck, North Dakota 58501 | |
| TN Oncology | Nashville, Tennessee 37203 |
