Methotrexate, Vinblastine, Doxorubicin and Cisplatin (MVAC) Followed by Gemcitabine Plus Cisplatin (GEM+CDDP) in Locally Advanced or Metastatic Bladder Cancer
Conditions
Bladder Cancer
Conditions: official terms
Urinary Bladder Neoplasms
Conditions: Keywords
Bladder Cancer
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Methotrexate Type: Drug
Name: Vinblastine Type: Drug
Name: Doxorubicin Type: Drug
Name: Cisplatin Type: Drug
Name: Cisplatin Type: Drug
Name: Gemcitabine Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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.
Locations
University General Hospital of Alexandroupolis, Dept. of Medical Oncology
Alexandroupolis, Greece
Status: Recruiting
Contact: Dora Hatzidaki - +302810392570 - dorachat@med.uoc.gr
401 Military Hospital, Medical Oncology Unit
Athens, Greece
Status: Recruiting
Contact: Nikoleta Karkatzou, MD - +302106448666 - secretary@horg.gr
Air Forces Military Hospital, Dept. of Medical Oncology
Athens, Greece
Status: Recruiting
Contact: Nikoleta Karkatzou, MD - +302106448666 - secretary@horg.gr
IASO General Hospital of Athens, 1st Dept. of Medical Oncology
Athens, Greece
Status: Recruiting
Contact: Nikoleta Karkatzou, MD - +302106442666 - secretary@horg.gr
Laikon General Hospital, Medical Oncology Unit, Propedeutic Dept. of Internal Medicine
Athens, Greece
Status: Recruiting
Contact: Nikoleta Karkatzou, MD - +302106448666 - secretary@horg.gr
Metaxa's Anticancer Hospital of Piraeus, 1st Dept. of Medical Oncology
Piraeus, Greece
Status: Recruiting
Contact: Nikoleta Karkatzou, MD - +302106448666 - secretary@horg.gr
Theagenion Anticancer Hospital of Thessaloniki
Thessaloniki, Greece
Status: Recruiting
Contact: Nikoleta Karkatzou, MD - +302106448666 - secretary@horg.gr
Start Date
February 2008
Completion Date
December 2014
Sponsors
Hellenic Oncology Research Group
Source
Hellenic Oncology Research Group
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page