Methotrexate, Vinblastine, Doxorubicin and Cisplatin (MVAC) Followed by Gemcitabine Plus Cisplatin (GEM+CDDP) in Locally Advanced or Metastatic Bladder Cancer
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Bladder Cancer |
| Intervention | Drug: Methotrexate Drug: Vinblastine Drug: Doxorubicin Drug: Cisplatin Drug: Cisplatin Drug: Gemcitabine |
| Phase | Phase 2 |
| Sponsor | Hellenic Oncology Research Group |
| Responsible Party | Hellenic Oncology Research Group |
| ClinicalTrials.gov Identifier | NCT00635726 |
| First Received | March 11, 2008 |
| Last Updated | August 30, 2013 |
| Last verified | August 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | March 11, 2008 |
|---|---|
| Last Updated Date | August 30, 2013 |
| Start Date | February 2008 |
| Estimated Primary Completion Date | March 2014 |
| Current Primary Outcome Measures | Overall response rate [Time Frame: Objective responses confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) (on 3rd and 6th cycle)] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Methotrexate, Vinblastine, Doxorubicin and Cisplatin (MVAC) Followed by Gemcitabine Plus Cisplatin (GEM+CDDP) in Locally Advanced or Metastatic Bladder Cancer |
|---|---|
| Official Title | Sequential High Dose MVAC (Methotrexate, Vinblastine, Doxorubicin and Cisplatin), Followed by Gemcitabine Plus Cisplatin in Treating Patients With Locally Advanced or Metastatic Bladder Cancer |
| 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 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. |
| 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 |
| Condition | Bladder Cancer |
| Intervention | Drug: Methotrexate Methotrexate intravenous (IV) 30 mgr/m2 on day 1 every 2 weeks for 6 courses Other Names: MethotrexateDrug: Vinblastine Vinblastine IV 3 mgr/m2 on day 1 every 2 weeks for 6 courses Other Names: VinblastineDrug: Doxorubicin Doxorubicin IV 30 mgr/m2 on day 2 every 2 weeks for 6 courses Other Names: DoxorubicinDrug: Cisplatin Cisplatin IV 70 mgr/m2 on day 2 every 2 weeks for 6 courses Other Names: CDDPDrug: Cisplatin Cisplatin IV 70 mgr/m2 on day 1 every 3 weeks for 4 courses Other Names: CDDPDrug: Gemcitabine Gemcitabine 1000 mgr/m2 on days 1 and 8 every 3 weeks for 4 courses Other Names: Gemzar |
| Study Arm (s) | Experimental: 1 MVAC -> GEM+CDDP |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 50 |
| Estimated Completion Date | March 2014 |
| Estimated Primary Completion Date | March 2014 |
| Eligibility 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. |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Dora Hatzidaki +302810392570 dorachat@med.uoc.gr |
| Location Countries | Greece |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00635726 |
|---|---|
| Other Study ID Numbers | CT/07.16 |
| Has Data Monitoring Committee | No |
| Information Provided By | Hellenic Oncology Research Group |
| Study Sponsor | Hellenic Oncology Research Group |
| Collaborators | University Hospital of Crete |
| Investigators | Principal Investigator: Nikos Androulakis, MD University Hospital of Crete, Dept. of Medical Oncology |
| Verification Date | August 2013 |
Locations[ + expand ][ + ]
| University General Hospital of Alexandroupolis, Dept. of Medical Oncology | Alexandroupolis, Greece Contact: Dora Hatzidaki | +302810392570 | dorachat@med.uoc.grPrincipal Investigator: Stelios Kakolyris, MD Recruiting |
|---|---|
| IASO General Hospital of Athens, 1st Dept. of Medical Oncology | Athens, Greece Contact: Nikoleta Karkatzou, MD | +302106442666 | secretary@horg.grPrincipal Investigator: Stelios Giassas, MD Recruiting |
| Laikon General Hospital, Medical Oncology Unit, Propedeutic Dept. of Internal Medicine | Athens, Greece Contact: Nikoleta Karkatzou, MD | +302106448666 | secretary@horg.grPrincipal Investigator: Aris Polyzos, MD Recruiting |
| 401 Military Hospital, Medical Oncology Unit | Athens, Greece Contact: Nikoleta Karkatzou, MD | +302106448666 | secretary@horg.grPrincipal Investigator: Charalambos Christophillakis, MD Recruiting |
| Air Forces Military Hospital, Dept. of Medical Oncology | Athens, Greece Contact: Nikoleta Karkatzou, MD | +302106448666 | secretary@horg.grPrincipal Investigator: Nikos Kentepozidis, MD Recruiting |
| Metaxa's Anticancer Hospital of Piraeus, 1st Dept. of Medical Oncology | Piraeus, Greece Contact: Nikoleta Karkatzou, MD | +302106448666 | secretary@horg.grPrincipal Investigator: Nikos Ziras, MD Recruiting |
| Theagenion Anticancer Hospital of Thessaloniki | Thessaloniki, Greece Contact: Nikoleta Karkatzou, MD | +302106448666 | secretary@horg.grPrincipal Investigator: Ioannis Boukovinas, MD Recruiting |