Randomized Phase II Study of Maintenance Pemetrexed Versus Observation for Patients With Malignant Pleural Mesothelioma Without Progression After First-Line Chemotherapy

Inclusion Criteria

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 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:

- 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 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