Pemetrexed Plus Gemcitabine Or Carboplatin In Patients With Advanced Malignant Mesothelioma: A Randomized Phase II Trial

CDR0000401795

RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, gemcitabine, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving pemetrexed disodium with gemcitabine is more effective than giving pemetrexed disodium with carboplatin in treating malignant pleural mesothelioma. PURPOSE: This randomized phase II trial is studying pemetrexed disodium with gemcitabine and pemetrexed disodium with carboplatin to see how well the combinations work compared to historical controls in treating patients with advanced malignant pleural mesothelioma.

2006-02-23

2009-09-01

2011-05-01

Completed

Early phase I

32

Inclusion Criteria: * Histologically or cytologically confirmed advanced mesothelioma of the pleura * Measurable disease, as defined by RECIST criteria, within 4 weeks of randomization. Patients with pleural rinds not measurable by RECIST were eligible if disease was evaluable within 4 weeks of randomization using mesothelioma response criteria * May have undergone pleurodesis. If pleurodesis was performed, there must have been at least a 2-week delay before Pemetrexed administration. A CT must have been performed after 2 weeks after pleurodesis to serve as the baseline scan. * ECOG Performance Status of 0 or 1 * Normal organ and marrow function, as defined by: * Absolute neutrophil count ≥ 1,500/ul * Platelet count ≥ 100,000/ul * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST and ALT ≤ 3 times ULN (5 times ULN if liver has tumor involvement) * Albumin ≥ 2.5 g/dL * Creatinine clearance ≥ 45 mL/min or Creatinine ≤ 2.0 g/dL * Age 18 years and over * Able to take folic acid and cyanocobalamin (vitamin B12) * Willing and able to take dexamethasone * Women of childbearing potential and sexually active men were required to use contraception during and for the first 3 months after the study Exclusion Criteria * A candidate for curative surgery * Prior radiation therapy to the target lesion, unless the lesion was clearly progressing per RECIST criteria after prior radiation and the interval between the most recent radiation therapy and enrollment was at least 4 weeks * Prior systemic chemotherapy for mesothelioma. Prior intracavitary cytotoxic drugs or immunomodulators were not permitted, unless given for the purpose of pleurodesis. * Active infection or serious concomitant systemic disorder * Second primary malignancy, other than in situ malignancies or adequately treated basal cell carcinoma of the skin or other malignancy treated at least 3 years previously with no evidence of recurrence. * Treatment with an investigational agent within 4 weeks before enrollment * Known or suspected brain metastases * Women must not be pregnant or breastfeeding * Obviously malnourished or with a weight loss of greater than 10% in the preceding 6 weeks * Aspirin or other nonsteroidal anti-inflammatory drugs for 2 days before, during, and for 2 days after each administration of pemetrexed disodium (5 days before, during, and 2 days after each administration of pemetrexed disodium for piroxicam, naproxen, diflunisal, or nabumetone)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 32, 'type': 'ACTUAL'}}

2023-07-03