NCT00374868

Pemetrexed Plus Cisplatin Bi-Weekly, in Patients With Urothelial Cancer (Metastatic, Locally Advanced or Non-Resectable)

Phase 1/2 Study of Biweekly ALIMTA Plus Cisplatin in Patients With Locally, Advanced, Non-Resectable or Metastatic Urothelial Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the anti-tumor activity, as measured by response rate to bi-weekly pemetrexed plus cisplatin, in chemo-naive patients with diagnosed metastatic or locally advanced (non-resectable) urothelial cancer.

Conditions

• Urologic Neoplasms

Interventions

Type	Name	Description
DRUG	pemetrexed	Phase 1: 300 mg/m\^2, intravenous (IV), days 1 and 15 every 28 days x 2 cycles (dose escalation: 300 mg/m\^2, 400 mg/m\^2, and 500 mg/m\^2) Phase 2: phase 1 determined dose, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
DRUG	cisplatin	Phase 1: 50 mg/m\^2, intravenous (IV), days 1 and 15 every 28 days x 2 cycles Phase 2: 50 mg/m\^2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy

Timeline

• Start date: 2006-08-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2006-09-12
• Last updated: 2010-11-04
• Results posted: 2009-06-17

Locations

5 sites across 1 country: Spain