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Title Randomized Phase II Study of Maintenance Pemetrexed versus observation for patients with malignant pleural mesothelioma without progression after first-line chemotherapy

IRB CALGB30901

CC 12-645

Hospital Beachwood, Fairview, Hillcrest, Independence, Main Campus, N/A, North Coast Cancer, Strongsville, Wooster

Stage N/A

Phase Phase 2

Disease Lung - Mesothelioma

Drug Pemetrexed

Description

Primary Objective

• To determine if maintenance therapy with pemetrexed improves progression-free survival in patients with malignant pleural mesothelioma who have at least stable disease after completion of first-line therapy with pemetrexed plus cisplatin or carboplatin.

Secondary Objective(s)

• To determine if maintenance therapy with pemetrexed improves overall survival.
• To evaluate frequency of responses to maintenance therapy with pemetrexed.
• To assess toxicity of maintenance therapy with pemetrexed.

Inclusion Criteria

1. Histologic Documentation: Histologically documented malignant pleural mesothelioma, epithelial, sarcomatoid or mixed type, not amenable to surgical resection.
2. Prior treatment
   • Currently receiving first-line treatment with pemetrexed + platinum. Patients are to be registered to CALGB 30901 no later than the last day of cycle 4 of first line therapy.
   • Prior intracavity 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.
3. Age ≥ 18 years
4. Non-pregnant and non-nursing since the effects of pemetrexed on the fetus/infant are unknown. In addition, 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).
5. 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.
   • ECOG performance status of 0-1
   • Required Randomization Initial Laboratory Data:
     • Granulocytes ≥ 1,500/ ul
     • Platelet count ≥ 100,000/ ul
     • Total Bilirubin ≤ 1.5 x ULN
     • AST (SGOT) ≤ 2 x ULN
     • Calculated Creatinine Clearance * ≥ 45 ml/min. The calculated creatinine clearance will be estimated by the Cockcroft-Gault formula as follows: (140-age) x wt. in kg./72 x serum creatinine x 0.85 for females OR 1.0 for males

Exclusion Criteria

Exclusion Criteria Not Available