Mesothelioma Clinical Trials
Disodium and Gemcitabine in Treating Patients With Malignant
This study is currently
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.
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
Official Title: Phase II Study of
Pemetrexed Disodium and Gemcitabine in Chemotherapy-Na´ve
Patients With Malignant Pleural or Peritoneal Mesothelioma
Further Study Details:
- Determine the objective tumor response rate in
chemotherapy-na´ve patients with malignant pleural
mesothelioma treated with pemetrexed disodium and
- Determine the median survival of patients with malignant
pleural or peritoneal mesothelioma treated with this
- 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
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
- Histologically confirmed malignant pleural or peritoneal
mesothelioma of 1 of the following subtypes:
- 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
- The following are not considered measurable disease:
- Pleural effusions
- Positive bone scans
- No known or suspected brain metastases