NCT00635726

Methotrexate, Vinblastine, Doxorubicin and Cisplatin (MVAC) Followed by Gemcitabine Plus Cisplatin (GEM+CDDP) in Locally Advanced or Metastatic Bladder Cancer

Sequential High Dose MVAC (Methotrexate, Vinblastine, Doxorubicin and Cisplatin), Followed by Gemcitabine Plus Cisplatin in Treating Patients With Locally Advanced or Metastatic Bladder Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Hellenic Oncology Research Group · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial will study the effectiveness and toxicity of sequential high dose MVAC followed by gemcitabine and cisplatin, as first line treatment in patients with locally advanced or metastatic bladder cancer.

Detailed description

High dose MVAC and Cisplatin/Gemcitabine combination regimens have shown comparable efficacy in the first line treatment of advanced or metastatic bladder cancer, whereas the latter regimen has better tolerability. The efficacy and tolerability of the sequential administration of these two regimens is not known.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
DRUG	Methotrexate	Methotrexate intravenous (IV) 30 mgr/m2 on day 1 every 2 weeks for 6 courses
DRUG	Vinblastine	Vinblastine IV 3 mgr/m2 on day 1 every 2 weeks for 6 courses
DRUG	Doxorubicin	Doxorubicin IV 30 mgr/m2 on day 2 every 2 weeks for 6 courses
DRUG	Cisplatin	Cisplatin IV 70 mgr/m2 on day 2 every 2 weeks for 6 courses
DRUG	Cisplatin	Cisplatin IV 70 mgr/m2 on day 1 every 3 weeks for 4 courses
DRUG	Gemcitabine	Gemcitabine 1000 mgr/m2 on days 1 and 8 every 3 weeks for 4 courses

Timeline

• Start date: 2008-02-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2008-03-14
• Last updated: 2015-10-08

Locations

7 sites across 1 country: Greece