NCT02693717

Pemetrexed Disodium in Treating Patients With Previously Treated Metastatic Urothelial Cancer

A Phase II Trial to Evaluate Pemetrexed Clinical Responses in Relation to Tumor MTAP Gene Status in Patients With Previously Treated Metastatic Urothelial Carcinoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well pemetrexed disodium works in treating patients with previously treated urothelial cancer that has spread from the primary site (place where it started) to other places in the body. Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: To determine the objective response rates (ORR) to pemetrexed disodium (pemetrexed) in patients with MTAP-deficient metastatic bladder cancer. SECONDARY OBJECTIVES: I. To determine the progression-free survival (PFS) for patients with MTAP-deficient metastatic bladder cancer treated with pemetrexed. II. To determine the overall survival (OS) for patients with MTAP-deficient metastatic bladder cancer treated with pemetrexed. III. Evaluate the toxicity of pemetrexed therapy for patients with MTAP-deficient metastatic bladder cancer. IV. Collect blood, urine, and tissue for future translational studies. OUTLINE: Patients receive pemetrexed disodium intravenously (IV) over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 3 weeks and then every 3 months for 5 years.

Conditions

• Metastatic Urothelial Carcinoma

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Pemetrexed Disodium	Given IV

Timeline

• Start date: 2017-05-09
• Primary completion: 2019-12-30
• Completion: 2019-12-30
• First posted: 2016-02-29
• Last updated: 2021-05-20
• Results posted: 2021-05-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study