Gemcitabine Plus Paclitaxel versus Gemcitabine alone in Patients with Recurrent or Advanced Urothelial Cancer previously Treated With Cisplatin-based Chemotherapy: A randomized Phase II study

UMIN ID: UMIN000002450

Registered date:01/10/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Urothelial cancer
• Date of first enrollment: 2009/07/01
• Target sample size: 80
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

gemcitabine/paclitaxel combination therapy
gemcitabine monotherapy

Outcome(s)

• Primary Outcome: To compare the response rate in patients with CDDP-resistant metastatic urothelial cancer treated with gemcitabine/paclitaxel or gemcitabine monotherapy

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. prior chemotherapy with gemcitabine or paclitaxel 2. patients with interstitial pneumoniae and pulmonary fibrosis 3. patients with body fluid with the necessity of drainage or severe edema 4. patients with brain metastasis with the necessity of treatment 5. active double cancer 6. severe or uncontrollable complications 7. patients with allergy to polyoxyethylene castor oil-contain drug (e.g., CDDP) or sclerosing castor oil-contain drug (e.g., injectable vitamins) 8. Not eligible for patients during Pregnancy or Lactation, and with the hope of pregnancy 9. Prior therapy is allowed if this is completed more than 28 days before study entry. 10. Otherwise, patients are judged to be not eligible by the attending doctor.

Related Information

• Primary Sponsor: Teikyo University
• Source(s) of Monetary Support: Teikyo University