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

• Status: Completed
• Trial end date: 2021-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Pemetrexed

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