Pemetrexed Disodium/Observation in Treating Patients W/ Malignant Pleural Mesothelioma w/Out Progressive Disease After 1st Line Chemotherapy
Condition: Malignant Mesothelioma
MeSH terms: Mesothelioma; Mesothelioma, Malignant
Intervention: pemetrexed disodium; clinical observation
Intervention description: Given IV
Intervention MeSH terms: Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: epithelial mesothelioma; sarcomatous mesothelioma; stage II malignant mesothelioma; stage III malignant mesothelioma; stage IV 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.
    

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