pemetrexed disodium/observation in treating patients w/ malignant pleural mesothelioma w/out progressive disease after 1st line chemotherapy

Conditions: Malignant Mesothelioma

Summary: 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.

objectives: primary * to determine if maintenance therapy with pemetrexed disodium versus observation improves progression-free survival of patients with malignant pleural mesothelioma who have at least stable disease after completion of first-line therapy comprising pemetrexed disodium with cisplatin or carboplatin. secondary * to determine the overall survival of patients treated with this regimen versus observation. * to evaluate the frequency of responses in patients treated with this regimen. * to assess the toxicity of this regimen in these patients. outline: this is a multicenter study. patients are stratified according to first-line chemotherapy regimen (cisplatin/pemetrexed disodium vs carboplatin/pemetrexed disodium), histologic subtype (epithelioid vs other) and number of courses received (\< 6 vs 6). * arm i: patients receive pemetrexed disodium iv over 10 minutes on day 1. treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. * arm ii: patients undergo observation until disease progression. after completion of study therapy, patients are followed up every 6 months for 3 years.

Eligibility criteria:
inclusion criteria: * 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: * 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

Keywords: epithelial mesothelioma sarcomatous mesothelioma stage ii malignant mesothelioma stage iii malignant mesothelioma stage iv malignant mesothelioma