Pemetrexed Disodium/Observation in Treating Patients W/ Malignant Pleural Mesothelioma w/Out Progressive Disease After 1st Line Chemotherapy

Launched by ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY · Mar 11, 2010

Keywords

ClinConnect Summary

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 multicente...

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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