Pemetrexed Observation in Treating Malignant Mesothelioma

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. Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

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Start Date: April 2010
Primary Completion Date: January 2012
Completion Date:
Last Updated Date: October 19, 2010

Disease Characteristics

Histologically confirmed malignant pleural mesothelioma meeting 1 of the following cell types:
- Epithelial
- Sarcomatoid
- Mixed type
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 ≥ 3 weeks and ≤ 6 weeks after the completion of course 4
No clinically significant pleural or peritoneal effusions that cannot be adequately managed by drainage before or during pemetrexed disodium

Patient Characteristics

ECOG performance status of 0-1
Life expectancy ≥ 12 weeks
Granulocytes ≥ 1,500/μL
Platelet count ≥ 100,000/μL
Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
AST ≤ 2 times ULN
Creatinine clearance ≥ 45 mL/min
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No psychiatric illness that would prevent the patient from giving informed consent
No second malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix unless curatively treated with no evidence of active disease for ≥ 5 years
No medical conditions that, in the opinion of the treating physician, would make study treatment unreasonably hazardous for the patient including, but not limited to, the following:
- Ongoing or active infection such as HIV positivity
- Inability to take oral medications
- Psychiatric illness/social situations that would limit compliance with study requirements

Prior Concurrent Therapy

See Disease Characteristics
Prior intracavitary cytotoxic or sclerosing therapy (including bleomycin) allowed
- Prior intrapleural cytotoxic chemotherapy not considered systemic chemotherapy
Prior surgery allowed
Prior radiotherapy allowed
- No concurrent palliative radiotherapy
No NSAIDS for 5 days before, during, or 2 days after study therapy
No concurrent hormones or other chemotherapeutic agents except for the following:
- Steroids for adrenal failure
- Hormones for nondisease-related conditions (e.g., insulin for diabetes)
- Intermittent use of dexamethasone as an antiemetic or premedication for pemetrexed disodium

Please refer to this study by its ClinicalTrials.gov identifier: NCT01085630.

For More Information On Participating In This Clinical Trial

University of Chicago Cancer Research Center
Chicago, Illinois 60637
773-834-7424
CCOP Hematology-Oncology Associates of Central New York
Goldsboro, North Carolina 27534
Contact: James N. Atkins, M.D.
919-580-0000
Kinston Medical Specialists
Kinston, North Carolina 27534
Contact: James N. Atkins, M.D.
919-580-0000
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at OSU
Columbus, Ohio 43210
866-627-7616
Christine LaGuardia Phillips Cancer Center
Kingsport, Tennessee 37662
423-224-5593
Danville Regional Medical Center
Danville, Virginia 24541
434-799-3753
Southwest Virginia Regional Cancer Center
Norton, Virginia 24273
Contact: Malcolm R. Mathews, M.D.
423-224-3150