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

ALIMTA Plus Gemcitabine as Front-Line Chemotherapy for Patients With Malignant Pleural or Peritoneal Mesothelioma: A Phase II Clinical Trial

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00061477

Enrollment

Registered

2003-05-29

Start date

2002-12-31

Completion date

2006-09-30

Last updated

2007-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

DRUGPemetrexed

DRUGGemcitabine

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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chemotherapy for mesothelioma * Treatment with an investigational drug within the last 30 days, previously completed or withdrawn from this study or any other study investigating Pemetrexed * Treatment with radiation therapy within the last 4 weeks * Brain metastasis that is uncontrolled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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026