- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00635726
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
Status
Terminated
Conditions
Intervention / Treatment
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
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Athens, Greece
- Laikon General Hospital, Medical Oncology Unit, Propedeutic Dept. of Internal Medicine
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Piraeus, Greece
- Metaxa's Anticancer Hospital of Piraeus, 1st Dept. of Medical Oncology
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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:
Cisplatin IV 70 mgr/m2 on day 1 every 3 weeks for 4 courses
Other Names:
Gemcitabine 1000 mgr/m2 on days 1 and 8 every 3 weeks for 4 courses
Other Names:
|
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.
Sponsor
Collaborators
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Urologic Diseases
- Urinary Bladder Diseases
- Urinary Bladder Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Dermatologic Agents
- Antibiotics, Antineoplastic
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Gemcitabine
- Cisplatin
- Doxorubicin
- Methotrexate
- Vinblastine
Other Study ID Numbers
- CT/07.16
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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