Status:
TERMINATED
Methotrexate, Vinblastine, Doxorubicin and Cisplatin (MVAC) Followed by Gemcitabine Plus Cisplatin (GEM+CDDP) in Locally Advanced or Metastatic Bladder Cancer
Lead Sponsor:
Hellenic Oncology Research Group
Collaborating Sponsors:
University Hospital of Crete
Conditions:
Bladder Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 metastati...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00635726
Start Date
February 1 2008
End Date
February 1 2013
Last Update
October 8 2015
Active Locations (7)
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1
University General Hospital of Alexandroupolis, Dept. of Medical Oncology
Alexandroupoli, Greece
2
401 Military Hospital, Medical Oncology Unit
Athens, Greece
3
Air Forces Military Hospital, Dept. of Medical Oncology
Athens, Greece
4
IASO General Hospital of Athens, 1st Dept. of Medical Oncology
Athens, Greece