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Mesothelioma Clinical Trials

Pemetrexed Disodium and Gemcitabine in Treating Patients With Malignant Mesothelioma

This study is currently recruiting patients.

Sponsored by

Ireland Cancer Center
For more information:National Cancer Institute (NCI)
 

RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy such as gemcitabine use different ways to stop tumor cells from dividing so they stop growing or die. Combining pemetrexed disodium with gemcitabine may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining pemetrexed disodium with gemcitabine in treating patients who have pleural or peritonealmalignant mesothelioma.

Condition Treatment or Intervention
advanced malignant mesothelioma
epithelial mesothelioma
sarcomatous mesothelioma
Drug: gemcitabine
Drug: pemetrexed disodium
Procedure: chemotherapy
Procedure: enzyme inhibitor therapy

This is a Phase II test

  • In Phase II clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.  

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Pemetrexed Disodium and Gemcitabine in Chemotherapy-Na´ve Patients With Malignant Pleural or Peritoneal Mesothelioma

Further Study Details: 

OBJECTIVES:

  • Determine the objective tumor response rate in chemotherapy-na´ve patients with malignant pleural mesothelioma treated with pemetrexed disodium and gemcitabine.
  • Determine the median survival of patients with malignant pleural or peritoneal mesothelioma treated with this regimen.
  • Determine the time to objective tumor response and duration of response in patients treated with this regimen.
  • Determine the time to treatment failure in patients treated with this regimen.
  • Determine the time to progressive disease in patients treated with this regimen.
  • Determine the progression-free and overall survival of patients treated with this regimen.
  • Determine the quantitative and qualitative toxic effects of this regimen in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and pemetrexed disodium IV over 8-15 minutes on day 8. Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 30 days and then every 3 months.

PROJECTED ACCRUAL: A total of 18-73 patients will be accrued for this study

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed malignant pleural or peritoneal mesothelioma of 1 of the following subtypes:
  • Epithelial
  • Sarcomatoid
  • Mixed subtype
  • Disease not amenable to curative surgery
  • Measurable disease
  • At least 1 measurable lesion at least 20 mm by conventional techniques or at least 10 mm by spiral CT scan
  • At least 1 level on lesion scan must have 1 pleural rind measurement at least 15 mm
  • If there is only 1 measurable lesion, the neoplastic nature must be histologically confirmed
  • Clinically detected lesions are only considered measurable if superficial (e.g., skin nodules and palpable lymph nodes)
  • The following are not considered measurable disease:
  • Pleural effusions
  • Positive bone scans
  • No known or suspected brain metastases


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