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Pemetrexed Plus Gemcitabine or Carboplatin for Patients With Advanced Malignant Pleural Mesothelioma

NCT00101283 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-07-03

Study results available
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Summary

RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, gemcitabine, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving pemetrexed disodium with gemcitabine is more effective than giving pemetrexed disodium with carboplatin in treating malignant pleural mesothelioma.

PURPOSE: This randomized phase II trial is studying pemetrexed disodium with gemcitabine and pemetrexed disodium with carboplatin to see how well the combinations work compared to historical controls in treating patients with advanced malignant pleural mesothelioma.

Conditions

Interventions

DRUG

pemetrexed disodium

500 mg/m2 IV over 10 minutes on day 1 of a 21-day cycle

DRUG

gemcitabine hydrochloride

1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle

DRUG

carboplatin

Given by IV over 30 minutes at an area under the curve (AUC) of 5 on day 1 of a 21-day cycle

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • North Central Cancer Treatment Group

    collaborator NETWORK

  • Eastern Cooperative Oncology Group

    lead NETWORK

Principal Investigators

  • Nasser H. Hanna, MD · Indiana University Melvin and Bren Simon Cancer Center

  • Scott Okuno, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-23
Primary Completion
2009-09-30
Completion
2011-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00101283 on ClinicalTrials.gov