Pemetrexed Disodium/Observation in Treating Patients W/ Malignant Pleural Mesothelioma w/Out Progressive Disease After 1st Line Chemotherapy
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria:
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Histologically confirmed malignant pleural mesothelioma meeting 1 of the following cell types:
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Epithelial
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Sarcomatoid
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Mixed type
- Histologically documented malignant pleural mesothelioma, epithelial, sarcomatoid or mixed type, not amenable to surgical resection
- Prior treatment
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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
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Prior intracavitary cytotoxic or sclerosing therapy (including bleomycin) are acceptable; prior intrapleural cytotoxic chemotherapy will not be considered systemic chemotherapy
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Prior surgical treatment is allowed
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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
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Disease not amenable to surgery
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Must be enrolled on imaging protocol CALGB-580903
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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
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No clinically significant pleural or peritoneal effusions that cannot be adequately managed by drainage before or during pemetrexed disodium
PATIENT CHARACTERISTICS:
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ECOG performance status of 0-1
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Life expectancy ≥ 12 weeks
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Granulocytes ≥ 1,500/μL
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Platelet count ≥ 100,000/μL
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Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
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AST ≤ 2 times ULN
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Creatinine clearance ≥ 45 mL/min
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Not pregnant or nursing
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Negative pregnancy test
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Fertile patients must use effective contraception
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No psychiatric illness that would prevent the patient from giving informed consent
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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
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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:
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See Disease Characteristics
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Prior intracavitary cytotoxic or sclerosing therapy (including bleomycin) allowed
- Prior intrapleural cytotoxic chemotherapy not considered systemic chemotherapy
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Prior surgery allowed
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Prior radiotherapy allowed
- No concurrent palliative radiotherapy
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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
Trial design
Primary purpose
Allocation
Interventional model
Masking
72 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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