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

October 7, 2015 updated by: Hellenic Oncology Research Group

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Alexandroupolis, Greece
        • University General Hospital of Alexandroupolis, Dept. of Medical Oncology
      • Athens, Greece
        • 401 Military Hospital, Medical Oncology Unit
      • Athens, Greece
        • Air Forces Military Hospital, Dept. of Medical Oncology
      • Athens, Greece
        • IASO General Hospital of Athens, 1st Dept. of Medical Oncology
      • Athens, Greece
        • Laikon General Hospital, Medical Oncology Unit, Propedeutic Dept. of Internal Medicine
      • Piraeus, Greece
        • Metaxa's Anticancer Hospital of Piraeus, 1st Dept. of Medical Oncology
      • Thessaloniki, Greece
        • Theagenion Anticancer Hospital of Thessaloniki

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically or cytologically confirmed transitional cell carcinoma of the urinary bladder.
  • Metastatic or locally advanced disease.
  • No prior chemotherapy.
  • Performance status (World Health Organization) 0-2.
  • Measurable or evaluable disease.
  • Measurable disease is defined as at least 1 unidimensional measurable lesion

    ≥20 mm by conventional techniques or 1 bidimensionally measurable lesion ≥ 20 X 10 mm. Lesions that are smaller or uni- or bidimensionally unmeasurable are considered as evaluable disease.

  • Adequate liver (bilirubin ≤ 1.5 Upper Normal Limit, serum glutamate-pyruvate aminotransferase/serum glutamic pyruvic transaminase ≤ 2 Upper Normal Limit, ALP ≤ 2.5 Upper Normal Limit), renal (creatinine ≤ 1.5 Upper Normal Limit) and bone marrow (absolute neutrophil count ≥ 1,500/mm3, platelet count ≥ 100,000/mm3) function.
  • Life expectancy > 3 months.
  • Patients must be able to understand the nature of this study and give written informed consent.

Exclusion Criteria:

  • History of serious cardiac disease (unstable angina, severe congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias).
  • Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer.
  • Active infection.
  • Uncontrolled inflammation.
  • Pregnant or lactating women.
  • Psychiatric illness or social situation that would preclude study compliance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
MVAC -> GEM+CDDP
Methotrexate intravenous (IV) 30 mgr/m2 on day 1 every 2 weeks for 6 courses
Vinblastine IV 3 mgr/m2 on day 1 every 2 weeks for 6 courses
Doxorubicin IV 30 mgr/m2 on day 2 every 2 weeks for 6 courses
Cisplatin IV 70 mgr/m2 on day 2 every 2 weeks for 6 courses
Other Names:
  • CDDP
Cisplatin IV 70 mgr/m2 on day 1 every 3 weeks for 4 courses
Other Names:
  • CDDP
Gemcitabine 1000 mgr/m2 on days 1 and 8 every 3 weeks for 4 courses
Other Names:
  • Gemzar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall response rate
Time Frame: Objective responses confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) (on 3rd and 6th cycle)
Objective responses confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) (on 3rd and 6th cycle)

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to tumor progression
Time Frame: 1-year
1-year
Overall survival
Time Frame: 1-year
1-year
Toxicity profile
Time Frame: Toxicity assessment on each chemotherapy cycle
Toxicity assessment on each chemotherapy cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nikos Androulakis, MD, University Hospital of Crete, Dept. of Medical Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

March 11, 2008

First Submitted That Met QC Criteria

March 13, 2008

First Posted (Estimate)

March 14, 2008

Study Record Updates

Last Update Posted (Estimate)

October 8, 2015

Last Update Submitted That Met QC Criteria

October 7, 2015

Last Verified

October 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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