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

Recruiting in Palo Alto (17 mi)

+122 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Eastern Cooperative Oncology Group

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Nasser H. Hanna, MD

Principal Investigator

Indiana University Melvin and Bren Simon Cancer Center

Scott Okuno, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

AST and ALT ≤ 3 times ULN (5 times ULN if liver has tumor involvement)

Albumin ≥ 2.5 g/dL

Creatinine clearance ≥ 45 mL/min or Creatinine ≤ 2.0 g/dL

Treatment Details

Interventions

• Carboplatin (Alkylating agents)
• Gemcitabine hydrochloride (Anti-metabolites)
• Pemetrexed disodium (Anti-metabolites)

Participant Groups

Group I: Pemetrexed/Gemcitabine Experimental Treatment 2 Interventions

Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.

Group II: Pemetrexed/Carboplatin Experimental Treatment 2 Interventions

Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to area under the curve (AUC) 5 IV over 30 minutes on day 1 of a 21-day cycle.

Carboplatin is already approved in Canada for the following indications:

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Who Is Running the Clinical Trial?

Eastern Cooperative Oncology Group

Lead Sponsor

Trials

272

Recruited

153,000+

Dr. Mitchell D. Schnall

Eastern Cooperative Oncology Group

Chief Medical Officer

MD, PhD from University of Pennsylvania

Dr. Peter J. O'Dwyer

Eastern Cooperative Oncology Group

Chief Executive Officer

MD from University of Pennsylvania

North Central Cancer Treatment Group

Collaborator

Trials

49

Recruited

81,100+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School