Columbia
The trial will determine the effectiveness of a course of treatment combining the drugs oxaliplatin and gemcitabine in treating tumors of patients diagnosed with malignant pleural mesothelioma or malignant peritoneal mesothelioma and who have not received more than one previous course of chemotherapy.
Oxaliplatin is a platinum-containing organic compound which targets cancer cells by inhibiting or specifically preventing replication and repair of the cancer cells’ DNA. Gemcitabine is a cancer drug which similarly targets the replication processes of cancer cells’ DNA by inhibiting the production of the cellular material which is necessary for DNA synthesis.
Oxaliplatin is marketed under the proprietary name ELOXATIN, and is manufactured by Sanofi Aventis, Inc. ELOXATIN is a commonly prescribed chemotherapeutic drug for patients with either advanced colon cancer or colorectal cancer. Gemcitabine is marketed under the trade name Gemzar, and is manufactured by Eli Lilly Co., and is frequently used in the treatment of breast, lung, ovarian, and pancreatic cancers.
Previous studies have shown their may be some efficacy in combining oxaliplatin with gemcitabine in combating mesothelioma. In a study published in December 2008, researchers from the Respiratory Disease Clinic Heckeshorn in
Researchers plan to enroll 29 patients in the study, which is expected to last 6 months. A thorough health screening will be performed on all prospective participants, using standard tests and medical assessments.
To be considered for the study, patients must be at least 18 years of age and have histologically confirmed malignant pleural or peritoneal mesothelioma which is not able to be treated surgically. Patients may have undergone pleurodesis in the past, but their must be at least a 2-week interval between when that procedure was performed and enrollment in the Phase II clinical trial. Patients may also have undergone one course of chemotherapy prior to the study. And all participants must have an estimated of life expectancy of more than 12 weeks.
Any patient who is pregnant or breast feeding, or who has an active infection, will not be considered for participation in the study. Additionally, patients with an active secondary malignancy, as well as those who have used any investigational drug or therapy within a month of enrollment, will not be included in the Phase II trial.
During the study period, all participants will receive both oxaliplatin and gemcitabine through IV infusions given separately and in succession, and all participants will receive six courses of treatment, unless adverse reactions occur which would make it necessary for treatment to stop. For patients who respond well to the initial six courses of chemotherapy, researchers may opt to continue treatment if it’s determined the patients would benefit.
Once the Phase II trial is completed, researchers plan to embark on a Phase III trial in 2010 or 2011.
