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

NCT00635726 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2015-10-08

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • University Hospital of Crete

    collaborator OTHER

  • Hellenic Oncology Research Group

    lead OTHER

Principal Investigators

  • Nikos Androulakis, MD · University Hospital of Crete, Dept. of Medical Oncology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • Greece

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00635726 on ClinicalTrials.gov