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

Primary Purpose

Bladder Cancer

Status

Terminated

Phase

Phase 2

Locations

Greece

Study Type

Interventional

Intervention

Methotrexate

Vinblastine

Doxorubicin

Cisplatin

Gemcitabine

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring Bladder Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University General Hospital of Alexandroupolis, Dept. of Medical Oncology
401 Military Hospital, Medical Oncology Unit
Air Forces Military Hospital, Dept. of Medical Oncology
IASO General Hospital of Athens, 1st Dept. of Medical Oncology
Laikon General Hospital, Medical Oncology Unit, Propedeutic Dept. of Internal Medicine
Metaxa's Anticancer Hospital of Piraeus, 1st Dept. of Medical Oncology
Theagenion Anticancer Hospital of Thessaloniki

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

MVAC -> GEM+CDDP

Outcomes

Primary Outcome Measures

Overall response rate

Secondary Outcome Measures

Time to tumor progression

Overall survival

Toxicity profile

Full Information

NCT ID

NCT00635726

First Posted

March 11, 2008

Last Updated

October 7, 2015

Sponsor

Hellenic Oncology Research Group

Collaborators

University Hospital of Crete

1. Study Identification

Unique Protocol Identification Number

NCT00635726

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Terminated

Why Stopped

Due to poor accrual

Study Start Date

February 2008 (undefined)

Primary Completion Date

February 2013 (Actual)

Study Completion Date

February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hellenic Oncology Research Group

Collaborators

University Hospital of Crete

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bladder Cancer

Keywords

Bladder Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

MVAC -> GEM+CDDP

Intervention Type

Drug

Intervention Name(s)

Methotrexate

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Vinblastine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Doxorubicin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Other Intervention Name(s)

CDDP

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Other Intervention Name(s)

CDDP

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Other Intervention Name(s)

Gemzar

Intervention Description

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

Primary Outcome Measure Information:

Title

Overall response rate

Time Frame

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

Secondary Outcome Measure Information:

Title

Time to tumor progression

Time Frame

1-year

Title

Overall survival

Time Frame

1-year

Title

Toxicity profile

Time Frame

Toxicity assessment on each chemotherapy cycle

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nikos Androulakis, MD

Organizational Affiliation

University Hospital of Crete, Dept. of Medical Oncology

Official's Role

Principal Investigator

Facility Information:

Facility Name

University General Hospital of Alexandroupolis, Dept. of Medical Oncology

City

Alexandroupolis

Country

Greece

Facility Name

401 Military Hospital, Medical Oncology Unit

City

Athens

Country

Greece

Facility Name

Air Forces Military Hospital, Dept. of Medical Oncology

City

Athens

Country

Greece

Facility Name

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

City

Athens

Country

Greece

Facility Name

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

City

Athens

Country

Greece

Facility Name

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

City

Piraeus

Country

Greece

Facility Name

Theagenion Anticancer Hospital of Thessaloniki

City

Thessaloniki

Country

Greece

12. IPD Sharing Statement

Learn more about this trial

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

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