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Pemetrexed Observation in Treating Patients With Malignant Pleural Mesothelioma

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. Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

  • Start Date: April 2010
  • Primary Completion Date: January 2012
  • Completion Date:
  • Last Updated Date: October 19, 2010

Disease Characteristics

  • Histologically confirmed malignant pleural mesothelioma meeting 1 of the following cell types:
    • Epithelial
    • Sarcomatoid
    • Mixed type
  • 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 ≥ 3 weeks and ≤ 6 weeks after the completion of course 4
  • 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 NSAIDS for 5 days before, during, or 2 days after study therapy
  • 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

Please refer to this study by its identifier: NCT01085630.

For More Information On Participating In This Clinical Trial

  • University of Chicago Cancer Research Center
    Chicago, Illinois 60637
  • CCOP Hematology-Oncology Associates of Central New York
    Goldsboro, North Carolina 27534
    Contact: James N. Atkins, M.D.
  • Kinston Medical Specialists
    Kinston, North Carolina 27534
    Contact: James N. Atkins, M.D.
  • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at OSU
    Columbus, Ohio 43210
  • Christine LaGuardia Phillips Cancer Center
    Kingsport, Tennessee 37662
  • Danville Regional Medical Center
    Danville, Virginia 24541
  • Southwest Virginia Regional Cancer Center
    Norton, Virginia 24273
    Contact: Malcolm R. Mathews, M.D.

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