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Pemetrexed Plus Gemcitabine as Front-Line Chemotherapy for Patients With Malignant Pleural or Peritoneal Mesothelioma

Brief Summary

The purposes of this study are to determine:

1. The safety of Pemetrexed plus Gemcitabine and any side effects that might be associated with the combination of these two drugs.

2. Whether Pemetrexed plus Gemcitabine can help patients with mesothelioma live longer.

3. Whether Pemetrexed plus Gemcitabine can make the tumor smaller or disappear, and for how long.

4. To see if patients feel better while taking Pemetrexed plus Gemcitabine.

Tracking Information
First Received DateMay 28, 2003
Last Changed DateJanuary 24, 2007
Start DateDecember 2002
Primary Outcome Measures

To determine the objective tumor response rate for pemetrexed plus gemcitabine every 21 days in patients with malignant pleural mesothelioma who have not received prior chemotherapy

Secondary Outcome Measures

To assess time to objective tumor response for responding patients;To assess duration of response for responding patients;To assess time to treatment failure;To assess time to progressive disease

To assess progression-free survival;To assess overall survival;To determine toxicities of pemetrexed in combination with gemcitabine in this population

Descriptive Information
PhasePhase 2
Study TypeInterventional
Condition
  • Mesothelioma
Intervention
  • Drug: Pemetrexed
  • Drug: Gemcitabine
Recruitment Information
Recruitment StatusCompleted
Enrollment48
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Eligibility Criteria

Inclusion Criteria:

- Diagnosis of mesothelioma that can be treated with chemotherapy

- Have received no prior chemotherapy for mesothelioma

- Have at least one measurable lesion

- Have an adequate performance status

- Sign an informed consent

Exclusion Criteria:

- Previous treatment with chemotherapy for mesothelioma

- Treatment with an investigational drug within the last 30 days, previously completed or withdrawn from this study or any other study investigating Pemetrexed

- Treatment with radiation therapy within the last 4 weeks

- Brain metastasis that is uncontrolled

- Active infection or other serious condition

Administrative Information
NCTIDNCT00061477
SponsorEli Lilly and Company
Verification DateJanuary 2007
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