Methotrexate, Vinblastine, Doxorubicin and Cisplatin (MVAC) Followed by Gemcitabine Plus Cisplatin (GEM+CDDP) in Locally Advanced or Metastatic Bladder Cancer - Full Text View

Sponsors and Collaborators:	Hellenic Oncology Research Group University Hospital of Crete
Information provided by:	Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:	NCT00635726

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	Intervention	Phase
Bladder Cancer	Drug: Methotrexate Drug: Vinblastine Drug: Doxorubicin Drug: Cisplatin Drug: Gemcitabine	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
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

Resource links provided by NLM:

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer

Drug Information available for: Methotrexate Cisplatin Doxorubicin Doxorubicin hydrochloride Gemcitabine Myocet Gemcitabine hydrochloride Vinblastine sulfate Vinblastine

U.S. FDA Resources

Further study details as provided by Hellenic Oncology Research Group:

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 ]

Secondary Outcome Measures:

Time to tumor progression [ Time Frame: 1-year ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: 1-year ] [ Designated as safety issue: No ]
Toxicity profile [ Time Frame: Toxicity assessment on each chemotherapy cycle ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	February 2008
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental MVAC -> GEM+CDDP	Drug: Methotrexate Methotrexate intravenous (IV) 30 mgr/m2 on day 1 every 2 weeks for 6 courses Drug: Vinblastine Vinblastine IV 3 mgr/m2 on day 1 every 2 weeks for 6 courses Drug: Doxorubicin Doxorubicin IV 30 mgr/m2 on day 2 every 2 weeks for 6 courses Drug: Cisplatin Cisplatin IV 70 mgr/m2 on day 2 every 2 weeks for 6 courses Drug: Cisplatin Cisplatin IV 70 mgr/m2 on day 1 every 3 weeks for 4 courses Drug: Gemcitabine Gemcitabine 1000 mgr/m2 on days 1 and 8 every 3 weeks for 4 courses

Arms

Assigned Interventions

1: Experimental

MVAC -> GEM+CDDP

Drug: Methotrexate

Methotrexate intravenous (IV) 30 mgr/m2 on day 1 every 2 weeks for 6 courses

Drug: Vinblastine

Vinblastine IV 3 mgr/m2 on day 1 every 2 weeks for 6 courses

Drug: Doxorubicin

Doxorubicin IV 30 mgr/m2 on day 2 every 2 weeks for 6 courses

Drug: Cisplatin

Cisplatin IV 70 mgr/m2 on day 2 every 2 weeks for 6 courses

Drug: Cisplatin

Cisplatin IV 70 mgr/m2 on day 1 every 3 weeks for 4 courses

Drug: Gemcitabine

Gemcitabine 1000 mgr/m2 on days 1 and 8 every 3 weeks for 4 courses

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00635726

Contacts

Contact: Dora Hatzidaki	+302810392570	dorachat@med.uoc.gr
Contact: Eva Maragkoudaki	+302810392857	dorachat@med.uoc.gr

Locations

Greece
IASO General Hospital of Athens, 1st Dept. of Medical Oncology	Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD +302106442666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Stelios Giassas, MD
Laikon General Hospital, Medical Oncology Unit, Propedeutic Dept. of Internal Medicine	Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Aris Polyzos, MD
Theagenion Anticancer Hospital of Thessaloniki	Recruiting
Thessaloniki, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Ioannis Boukovinas, MD
Metaxa's Anticancer Hospital of Piraeus, 1st Dept. of Medical Oncology	Recruiting
Piraeus, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Nikos Ziras, MD
Air Forces Military Hospital, Dept. of Medical Oncology	Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Nikos Kentepozidis, MD
University General Hospital of Alexandroupolis, Dept. of Medical Oncology	Recruiting
Alexandroupolis, Greece
Contact: Dora Hatzidaki +302810392570 dorachat@med.uoc.gr
Contact: Eva Maragkoudaki +30281392857 dorachat@med.uoc.gr
Principal Investigator: Stelios Kakolyris, MD
401 Military Hospital, Medical Oncology Unit	Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Charalambos Christophillakis, MD

Sponsors and Collaborators

Hellenic Oncology Research Group

University Hospital of Crete

Investigators

Principal Investigator:

Nikos Androulakis, MD

University Hospital of Crete, Dept. of Medical Oncology

More Information

No publications provided

Responsible Party:	Hellenic Oncology Research Group ( N. Androulakis )
Study ID Numbers:	CT/07.16
Study First Received:	March 11, 2008
Last Updated:	April 13, 2009
ClinicalTrials.gov Identifier:	NCT00635726 History of Changes
Health Authority:	Greece: National Organization of Medicines

Keywords provided by Hellenic Oncology Research Group:

Bladder Cancer

Study placed in the following topic categories:

Antimetabolites
Anti-Infective Agents
Urinary Tract Neoplasm
Immunologic Factors
Folate
Vinblastine
Urogenital Neoplasms
Urologic Neoplasms
Vitamin B9
Anti-Bacterial Agents
Cisplatin
Urologic Diseases
Methotrexate
Bladder Neoplasm
Gemcitabine

Cystocele
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Antimitotic Agents
Folinic Acid
Folic Acid Antagonists
Immunosuppressive Agents
Antiviral Agents
Doxorubicin
Folic Acid
Radiation-Sensitizing Agents
Tubulin Modulators
Antirheumatic Agents
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Vinblastine
Urogenital Neoplasms
Reproductive Control Agents
Urologic Neoplasms
Antibiotics, Antineoplastic
Neoplasms by Site
Cisplatin
Urologic Diseases

Therapeutic Uses
Abortifacient Agents
Methotrexate
Gemcitabine
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Mitosis Modulators
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Enzyme Inhibitors
Antimitotic Agents
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Antiviral Agents
Immunosuppressive Agents

ClinicalTrials.gov processed this record on September 10, 2009