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Brief Title: Study of CBP501 + Pemetrexed + Cisplatin on MPM (Phase I/II)
Official Title: Phase I/II Study of a Triplet Combination of CBP501, Pemetrexed and Cisplatin in Patients With Advanced Solid Tumors and in Chemotherapy-naïve Patients With Malignant Pleural Mesothelioma
Study ID: NCT00700336
Brief Summary: The phase I part of the study is a dose-finding study of escalating doses of CBP501 combined with full-dose cisplatin and pemetrexed in patients with histologically confirmed solid malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective or would otherwise be eligible for cisplatin and pemetrexed as first-line therapy. The maximum tolerated dose (MTD) will be determined based on DLTs occurring during the first treatment cycle. Pharmacokinetics of the triplet combination will be assessed during the phase I part of the trial. The phase II part will evaluate full-dose cisplatin and pemetrexed combined with CBP501 (at the MTD determined in the phase I part) in previously untreated, unresectable malignant pleural mesothelioma patients. Patients will be randomized in a 2 : 1 ratio to pemetrexed, cisplatin and CBP501 (Arm A) or to pemetrexed and cisplatin (Arm B); randomization will be stratified according to histology and performance status.
Detailed Description: This is an open-label, multicenter, international, phase I-II study. The phase I part, a dose-finding study of escalating doses of CBP501 combined with fixed full-dose cisplatin and pemetrexed, has been completed and results are presented in this report. MTD was determined on DLT occurring during the first cycle. This phase I part was evaluated in a patient population with advanced solid tumors The phase II part will evaluate full-dose cisplatin and pemetrexed combined with CBP501 at the MTD determined in the phase I part. Patients will be randomized in a 2:1 ratio to pemetrexed, cisplatin and CBP501 (Arm A) or pemetrexed and cisplatin (Arm B). This phase II part will be evaluated in chemotherapy-naïve patients with malignant pleural mesothelioma Randomization will be stratified by: * Histology: epithelial vs other (sarcomatoid or biphasic) * Performance status: 0-1 vs 2
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic, Scottsdale, Arizona, United States
Arizona Cancer Center, Tucson, Arizona, United States
City of Hope, Duarte, California, United States
University of Chicago, Chicago, Illinois, United States
Karmanos Cancer Institute/Wayne State University, Detroit, Michigan, United States
Nevada Cancer Institute, Las Vegas, Nevada, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
Memorial-Sloan Kettering Cancer Center, New York, New York, United States
Cleveland Clinic, Cleveland, Ohio, United States
Penn State Milton S. Hershey Medical Ctr., Hershey, Pennsylvania, United States
Cancer Therapy & Research Center, San Antonio, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Name: Lee Krug
Affiliation: Memorial Sloan Kettering Cancer Center
Role: PRINCIPAL_INVESTIGATOR