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

Lilly

Status and phase: Completed; Phase 2

Conditions: Mesothelioma

Treatments: Drug: Pemetrexed; Drug: Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00061477

7214

H3E-US-JMFZ

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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• Treatment with an investigational drug within the last 30 days, previously completed or withdrawn from this study or any other study investigating Pemetrexed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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)