Oxaliplatin (Eloxatin®) Plus Gemcitabine as First or Second-line Chemotherapy for Patients With Malignant Pleural or Peritoneal Mesothelioma: A Phase II Clinical Trial
Oxaliplatin (ELOXATIN®) is an organoplatinum complex which exerts its cytotoxic effect
chiefly through inhibition of tumoral DNA synthesis and repair, leading to cellular
apoptosis. The antiproliferative activity of oxaliplatin has been shown to approximate that
of cisplatin or carboplatin in different tumor types.
This is a phase II clinical trial of Oxaliplatin (ELOXATIN®) plus gemcitabine as first or
secondline chemotherapy for patients with malignant pleural or peritoneal mesothelioma. This
study aims to determine the objective tumor response rate for Oxaliplatin plus gemcitabine
given every 14 days in patients with malignant pleural mesothelioma and/or malignant
peritoneal mesothelioma who have no more than one prior chemotherapy regimen. A total of 29
patients are expected to be enrolled in the study, each with a participation duration of 6
months.
Patients will be screened using standard health care assessments and tests. All of these
tests must be done within 4 weeks before patients begin treatment. Patients who are deemed
eligible will start the treatment cycle, defined as an interval of 14 days, and comprising
of treatment with Gemcitabine followed immediately by Oxaliplatin. The study drugs will be
administered in the following manner: Gemcitabine, at 1000 mg/m² IV infusion over 90
minutes, then Oxaliplatin, at 100 mg/m² IV infusion over 2 hours.
In the absence of specific indications for discontinuation of study drugs, patients will
routinely be offered 6 cycles of therapy. Further cycles may be given if in the opinion of
the investigator this is in the patient's best interest.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Best Response
Radiologic response by RECIST criteria
Two months
Yes
Robert N Taub, MD, PhD
Principal Investigator
Columbia University
United States: Institutional Review Board
AAAA2861 (Final)
NCT00859469
April 2004
March 2013
Name | Location |
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Columbia University Medical Center | New York, New York 10032 |