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ACTIVE NOT RECRUITING
NCT02535312
PHASE1/PHASE2

Methoxyamine, Cisplatin, and Pemetrexed Disodium in Treating Patients With Advanced Solid Tumors or Mesothelioma That Cannot Be Removed by Surgery or Mesothelioma That Is Refractory to Pemetrexed Disodium and Cisplatin or Carboplatin

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

This phase I/II trial studies the side effects and the best dose of methoxyamine when given together with cisplatin and pemetrexed disodium and to see how well it works in treating patients with solid tumors or mesothelioma that have spread to other places in the body and usually cannot be cured or controlled with standard treatment (advanced), or mesothelioma that does not respond to pemetrexed disodium and cisplatin or carboplatin (refractory). Methoxyamine may shrink the tumor and may also help cisplatin and pemetrexed disodium work better by making tumor cells more sensitive to the drugs. Drugs used in chemotherapy, such as cisplatin and pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving methoxyamine together with cisplatin and pemetrexed disodium may be a better treatment for solid tumors or mesothelioma than methoxyamine and pemetrexed disodium.

Official title: Phase I Study of TRC102 in Combination With Cisplatin and Pemetrexed in Patients With Advanced Solid Tumors / Phase II Study of TRC102 With Pemetrexed in Patients Refractory to Pemetrexed and Cisplatin or Carboplatin

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2016-03-08

Completion Date

2026-10-15

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

DRUG

Cisplatin

Given IV

DRUG

Methoxyamine

Given PO

DRUG

Pemetrexed Disodium

Given IV

Locations (14)

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Los Angeles General Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Keck Medical Center of USC Pasadena

Pasadena, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, United States

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

Vanderbilt Breast Center at One Hundred Oaks

Nashville, Tennessee, United States

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, United States