Abstract | PURPOSE: PATIENTS AND METHODS: Patients (n = 38) not previously treated with capecitabine received P-CAP ( perifosine 50 mg orally once daily, days 1 to 21 and CAP 825 mg/m(2) orally twice daily, days 1 to 14) or CAP (825 mg/m(2) orally twice daily, days 1 to 14) in 21-day cycles until disease progression. The primary end point was time to progression ( TTP). Secondary end points included overall survival (OS), overall response rate (ORR), safety, and tolerability. RESULTS: Twenty patients were randomly assigned to P-CAP and 18 to CAP. Median TTP (27.5 v 10.1 weeks; P < .001) and median OS (17.7 v 7.6 months; P = .0052) were improved in patients receiving P-CAP versus CAP. ORR was 20% v 7% in the P-CAP and CAP groups, respectively, and one patient in the P-CAP group had a complete response. A subset analysis of fluorouracil-refractory patients showed a median TTP of 17.6 v 9.0 weeks (P < .001) and median OS of 15.1 v 6.5 months (P = .0061). Toxicities, including diarrhea, nausea, fatigue, and hand-foot syndrome, were manageable. CONCLUSION: P-CAP showed promising clinical activity compared with CAP in previously treated patients with mCRC. A phase III trial is underway comparing P-CAP with CAP in patients with refractory mCRC.
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Authors | Johanna C Bendell, John Nemunaitis, Sasha J Vukelja, Christopher Hagenstad, Luis T Campos, Robert C Hermann, Peter Sportelli, Lesa Gardner, Donald A Richards |
Journal | Journal of clinical oncology : official journal of the American Society of Clinical Oncology
(J Clin Oncol)
Vol. 29
Issue 33
Pg. 4394-400
(Nov 20 2011)
ISSN: 1527-7755 [Electronic] United States |
PMID | 21969495
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Deoxycytidine
- Phosphorylcholine
- perifosine
- Capecitabine
- Fluorouracil
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects, therapeutic use)
- Capecitabine
- Colorectal Neoplasms
(drug therapy, mortality, pathology)
- Deoxycytidine
(administration & dosage, analogs & derivatives)
- Double-Blind Method
- Fluorouracil
(administration & dosage, analogs & derivatives)
- Humans
- Middle Aged
- Neoplasm Metastasis
- Phosphorylcholine
(administration & dosage, analogs & derivatives)
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