Pemetrexed Disodium/Observation in Treating Patients W/ Malignant Pleural Mesothelioma w/Out Progressive Disease After 1st Line Chemotherapy

Completed · Phase 2

Conditions studied: Malignant Mesothelioma

In brief

RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This randomized phase II trial is studying how well pemetrexed disodium or observation works in treating patients with malignant pleural mesothelioma without progressive disease after first-line chemotherapy.

Key facts

Study ID

NCT01085630

Run by

Alliance for Clinical Trials in Oncology

People needed

72

Starts

2010-04-01

Expected to finish

2021-04-01

Last updated by the study team

2021-08-18

Who can join

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

You may qualify if…

• Histologically confirmed malignant pleural mesothelioma meeting 1 of the following cell types:
• Epithelial
• Sarcomatoid
• Mixed type
• Histologically documented malignant pleural mesothelioma, epithelial, sarcomatoid or mixed type, not amenable to surgical resection
• Prior treatment
• Currently receiving first-line treatment with pemetrexed + platinum; patients are to be registered to Cancer and Leukemia Group B (CALGB) 30901 no later than the last day of cycle 4 of first line therapy
• Prior intracavitary cytotoxic or sclerosing therapy (including bleomycin) are acceptable; prior intrapleural cytotoxic chemotherapy will not be considered systemic chemotherapy
• Prior surgical treatment is allowed
• Prior radiation therapy is allowed
• Non-pregnant and non-nursing; women of child bearing potential and men must agree to use an appropriate method of birth control throughout their participation in this study; appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives (Norplant), or double barrier methods (diaphragm plus condom)
• RANDOMIZATION ELIGIBILITY CRITERIA
• Patients with complete response, partial response, or stable disease following 4, 5 or 6 cycles of first-line chemotherapy with pemetrexed AND either cisplatin or carboplatin; a maximum of 6 cycles of chemotherapy may have been given
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Granulocytes >= 1,500/ul
• Platelet count >= 100,000/ul
• Total bilirubin =< 1.5 x upper limit of normal (ULN)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 2 x ULN
• Calculated creatinine clearance >= 45 ml/min
• Disease not amenable to surgery
• Must be enrolled on imaging protocol CALGB-580903
• Complete response, partial response, or stable disease after completion of 4 courses of first-line chemotherapy comprising pemetrexed disodium AND cisplatin or carboplatin
• Study therapy will begin within 9 weeks following day 1 of cycle 4 of first-line treatment
• No clinically significant pleural or peritoneal effusions that cannot be adequately managed by drainage before or during pemetrexed disodium
• PATIENT CHARACTERISTICS:

Where it is running

• Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center — Wilkes-Barre, Pennsylvania, United States
• Roper St. Francis Cancer Center at Roper Hospital — Charleston, South Carolina, United States
• Danville Regional Medical Center — Danville, Virginia, United States
• Southwest Washington Medical Center Cancer Center — Vancouver, Washington, United States
• Northwest Cancer Specialists at Vancouver Cancer Center — Vancouver, Washington, United States
• Gundersen Lutheran Center for Cancer and Blood — La Crosse, Wisconsin, United States
• Mayo Clinic Scottsdale — Scottsdale, Arizona, United States
• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center — Hartford, Connecticut, United States
• George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus — New Britain, Connecticut, United States
• Tunnell Cancer Center at Beebe Medical Center — Lewes, Delaware, United States
• CCOP - Christiana Care Health Services — Newark, Delaware, United States
• Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center — Boise, Idaho, United States
• Illinois CancerCare - Bloomington — Bloomington, Illinois, United States
• St. Joseph Medical Center — Bloomington, Illinois, United States
• Illinois CancerCare - Canton — Canton, Illinois, United States
• Illinois CancerCare - Carthage — Carthage, Illinois, United States
• University of Chicago Cancer Research Center — Chicago, Illinois, United States
• Eureka Community Hospital — Eureka, Illinois, United States
• Illinois CancerCare - Eureka — Eureka, Illinois, United States
• Galesburg Clinic, PC — Galesburg, Illinois, United States
• Illinois CancerCare - Havana — Havana, Illinois, United States
• Illinois CancerCare - Kewanee Clinic — Kewanee, Illinois, United States
• La Grange Memorial Hospital — La Grange, Illinois, United States
• Geisinger Medical Group - Scenery Park — State College, Pennsylvania, United States

Full record on ClinicalTrials.gov

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