At a glance
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Phase 1/2 Study of Biweekly ALIMTA Plus Cisplatin in Patients With Locally, Advanced, Non-Resectable or Metastatic Urothelial Cancer
In Brief
A Phase 2 clinical trial evaluating pemetrexed and cisplatin for Urologic Neoplasms. Completed, enrolled 59 participants across 5 sites.
Detailed 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.
Study Details
Timeline
Interventions
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
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