CompletedPhase 2NCT01085630

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

StatusCompleted
PhasePhase 2
U.S. locations145
SponsorAlliance for Clinical Trials in Oncology
01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Treatment approach
03
Public criteria

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.

04
Study sites

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.

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