Pemetrexed Disodium/Observation in Treating Patients W/ Malignant Pleural Mesothelioma w/Out Progressive Disease After 1st Line Chemotherapy
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.
Checked against the public recordLast updated Aug 18, 2021 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Alliance for Clinical Trials in Oncology
- Interventions being studied
- Drug: pemetrexed disodium; Other: clinical observation
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Mayo Clinic ScottsdaleScottsdale, Arizona
- UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical CenterHartford, Connecticut
- George Bray Cancer Center at the Hospital of Central Connecticut - New Britain CampusNew Britain, Connecticut
- Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware
- CCOP - Christiana Care Health ServicesNewark, Delaware
- Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical CenterBoise, Idaho
- Illinois CancerCare - BloomingtonBloomington, Illinois
- St. Joseph Medical CenterBloomington, Illinois
- Illinois CancerCare - CantonCanton, Illinois
- Illinois CancerCare - CarthageCarthage, Illinois
- University of Chicago Cancer Research CenterChicago, Illinois
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 18, 2021. Always confirm current availability with the study team.