Colorectal Cancer
Conditions
Brief summary
The trial will compare the overall survival of perifosine plus capecitabine to placebo plus capecitabine in patients with refractory advanced colorectal cancer.
Interventions
DRUGCapecitabine
1000 mg/m2 BID/ Days 1-14
DRUGPerifosine
50 mg daily x 21 days
DRUGPlacebo
1 pill daily x 21 days
Sponsors
AEterna Zentaris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | Monthly |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free Survival | Every 6 weeks |
Countries
United States
Outcome results
None listed