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.
|First Received Date||May 28, 2003|
|Last Changed Date||January 24, 2007|
|Start Date||December 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
|Ages||18 Years - N/A|
|Accepts Healthy Volunteers||No|
- 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
- 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- Treatment with an investigational drug within the last 30 days, previously completed or withdrawn from this study or any other study investigating Pemetrexed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
|Sponsor||Eli Lilly and Company|
|Verification Date||January 2007|