Pemetrexed Plus Gemcitabine or Carboplatin for Patients With Advanced Malignant Pleural Mesothelioma

Completed · Phase 2

Conditions studied: Mesothelioma

In brief

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.

Key facts

Study ID

NCT00101283

Run by

Eastern Cooperative Oncology Group

People needed

32

Starts

2006-02-23

Expected to finish

2011-05-01

Last updated by the study team

2023-07-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Tunnell Cancer Center at Beebe Medical Center — Lewes, Delaware, United States
• CCOP - Christiana Care Health Services — Newark, Delaware, United States
• Mayo Clinic - Jacksonville — Jacksonville, Florida, United States
• Winship Cancer Institute of Emory University — Atlanta, Georgia, United States
• Rush-Copley Cancer Care Center — Aurora, Illinois, United States
• St. Joseph Medical Center — Bloomington, Illinois, United States
• Graham Hospital — Canton, Illinois, United States
• Memorial Hospital — Carthage, Illinois, United States
• Decatur Memorial Hospital Cancer Care Institute — Decatur, Illinois, United States
• Eureka Community Hospital — Eureka, Illinois, United States
• Galesburg Clinic, PC — Galesburg, Illinois, United States
• Galesburg Cottage Hospital — Galesburg, Illinois, United States
• Mason District Hospital — Havana, Illinois, United States
• Hopedale Medical Complex — Hopedale, Illinois, United States
• Joliet Oncology-Hematology Associates, Limited - West — Joliet, Illinois, United States
• Kewanee Hospital — Kewanee, Illinois, United States
• McDonough District Hospital — Macomb, Illinois, United States
• Trinity Cancer Center at Trinity Medical Center - 7th Street Campus — Moline, Illinois, United States
• BroMenn Regional Medical Center — Normal, Illinois, United States
• Community Cancer Center — Normal, Illinois, United States
• Community Hospital of Ottawa — Ottawa, Illinois, United States
• Oncology Hematology Associates of Central Illinois, PC - Ottawa — Ottawa, Illinois, United States
• Cancer Treatment Center at Pekin Hospital — Pekin, Illinois, United States
• Proctor Hospital — Peoria, Illinois, United States
• Eastern Connecticut Hematology and Oncology Associates — Norwich, Connecticut, United States

Full record on ClinicalTrials.gov

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