Methotrexate, Vinblastine, Doxorubicin and Cisplatin (MVAC) Followed by Gemcitabine Plus Cisplatin (GEM+CDDP) in Locally Advanced or Metastatic Bladder Cancer
NCT ID: NCT00635726
Last Updated: 2015-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
41 participants
INTERVENTIONAL
2008-02-29
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
MVAC -\> GEM+CDDP
Methotrexate
Methotrexate intravenous (IV) 30 mgr/m2 on day 1 every 2 weeks for 6 courses
Vinblastine
Vinblastine IV 3 mgr/m2 on day 1 every 2 weeks for 6 courses
Doxorubicin
Doxorubicin IV 30 mgr/m2 on day 2 every 2 weeks for 6 courses
Cisplatin
Cisplatin IV 70 mgr/m2 on day 2 every 2 weeks for 6 courses
Cisplatin
Cisplatin IV 70 mgr/m2 on day 1 every 3 weeks for 4 courses
Gemcitabine
Gemcitabine 1000 mgr/m2 on days 1 and 8 every 3 weeks for 4 courses
Interventions
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Methotrexate
Methotrexate intravenous (IV) 30 mgr/m2 on day 1 every 2 weeks for 6 courses
Vinblastine
Vinblastine IV 3 mgr/m2 on day 1 every 2 weeks for 6 courses
Doxorubicin
Doxorubicin IV 30 mgr/m2 on day 2 every 2 weeks for 6 courses
Cisplatin
Cisplatin IV 70 mgr/m2 on day 2 every 2 weeks for 6 courses
Cisplatin
Cisplatin IV 70 mgr/m2 on day 1 every 3 weeks for 4 courses
Gemcitabine
Gemcitabine 1000 mgr/m2 on days 1 and 8 every 3 weeks for 4 courses
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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University Hospital of Crete
OTHER
Hellenic Oncology Research Group
OTHER
Responsible Party
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Principal Investigators
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Nikos Androulakis, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Crete, Dept. of Medical Oncology
Locations
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University General Hospital of Alexandroupolis, Dept. of Medical Oncology
Alexandroupoli, , 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
Athens, , Greece
Metaxa's Anticancer Hospital of Piraeus, 1st Dept. of Medical Oncology
Piraeus, , Greece
Theagenion Anticancer Hospital of Thessaloniki
Thessaloniki, , Greece
Countries
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Other Identifiers
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CT/07.16
Identifier Type: -
Identifier Source: org_study_id
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