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

NCT00635726 | Terminated Phase 2

• 1 other identifier: CT/07.16
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 7

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.

Conditions

Bladder Cancer

Keywords

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  Objective responses confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) (on 3rd and 6th cycle)

Secondary Outcomes (3)

• Time to tumor progression

  1-year

• Overall survival

  1-year

• Toxicity profile

  Toxicity assessment on each chemotherapy cycle

Study Arms (1)

1

EXPERIMENTAL

MVAC -\> GEM+CDDP

Drug: Methotrexate; Drug: Vinblastine; Drug: Doxorubicin; Drug: Cisplatin; Drug: Gemcitabine

Interventions

Methotrexate DRUG

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

1

Vinblastine DRUG

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

1

Doxorubicin DRUG

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

1

Cisplatin DRUG

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

Also known as: CDDP

1

Gemcitabine DRUG

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

Also known as: Gemzar

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hellenic Oncology Research Group: lead
• University Hospital of Crete: collaborator

Study Sites (7)

University General Hospital of Alexandroupolis, Dept. of Medical Oncology

Alexandroupoli, Greece

Location

401 Military Hospital, Medical Oncology Unit

Athens, Greece

Location

Air Forces Military Hospital, Dept. of Medical Oncology

Athens, Greece

Location

IASO General Hospital of Athens, 1st Dept. of Medical Oncology

Athens, Greece

Location

Laikon General Hospital, Medical Oncology Unit, Propedeutic Dept. of Internal Medicine

Athens, Greece

Location

Metaxa's Anticancer Hospital of Piraeus, 1st Dept. of Medical Oncology

Piraeus, Greece

Location

Theagenion Anticancer Hospital of Thessaloniki

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Methotrexate; Vinblastine; Doxorubicin; Cisplatin; Gemcitabine

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Nikos Androulakis, MD

  University Hospital of Crete, Dept. of Medical Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2008
• First Posted: March 14, 2008
• Study Start: February 1, 2008
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: October 8, 2015

Record last verified: 2015-10

Locations

GR (7)