Eloxatin® Plus Gemcitabine Chemotherapy for Mesothelioma
|ClinicalTrials.gov Identifier: NCT00859469|
Recruitment Status : Unknown
Verified January 2012 by Columbia University.
Recruitment status was: Active, not recruiting
First Posted : March 11, 2009
Results First Posted : February 24, 2012
Last Update Posted : February 24, 2012
|Condition or disease||Intervention/treatment||Phase|
|Mesothelioma||Drug: Oxaliplatin/Gemcitabine||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Oxaliplatin (Eloxatin®) Plus Gemcitabine as First or Second-line Chemotherapy for Patients With Malignant Pleural or Peritoneal Mesothelioma: A Phase II Clinical Trial|
|Study Start Date :||April 2004|
|Primary Completion Date :||March 2009|
|Estimated Study Completion Date :||March 2013|
|Experimental: Oxaliplatin and Gemcitabine||
Gemcitabine 1000mg/m2 IV infusion for 90 minutes followed by oxaliplatin 100 mg/m2 IV infusion for 2 hours repeated for 14 days up to 6 cycles
- Best Response [ Time Frame: Two months ]Radiologic response by RECIST criteria
- Overall Survival [ Time Frame: 50 months ]
- Progression-free Survival [ Time Frame: 50 months ]Time to radiologic disease progression or death
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00859469
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Robert N Taub, MD, PhD||Columbia University|