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Pemetrexed Disodium or Observation in Treating Patients With Malignant Pleural Mesothelioma Without Progressive Disease After First-Line Chemotherapy

Published: March 11, 2010

Primary Outcome Measures:

  • Progression-free survival: 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 Outcome Measures:

  • Overall survival: To determine the overall survival of patients treated with this regimen versus observation.
  • Frequency of responses: To evaluate the frequency of responses in patients treated with this regimen.
  • Toxicity: To assess the toxicity of this regimen in these patients.

Detailed Description:

Outline: This is a multicenter study. Patients are stratified according to first-line chemotherapy regimen (cisplatin/pemetrexed disodium vs carboplatin/pemetrexed disodium) and histologic subtype (epithelioid vs other).

  • Arm I: Patients receive pemetrexed disodium IV over 10 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients undergo observation until disease progression. After completion of study therapy, patients are followed up every 6 months for 3 years.


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
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
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
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