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

Sequential High Dose MVAC (Methotrexate, Vinblastine, Doxorubicin and Cisplatin), Followed by Gemcitabine Plus Cisplatin in Treating Patients With Locally Advanced or Metastatic Bladder Cancer

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00635726

Enrollment

Registered

2008-03-14

Start date

2008-02-29

Completion date

2013-02-28

Last updated

2015-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

Keywords

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.

Interventions

DRUGMethotrexate

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

DRUGVinblastine

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

DRUGDoxorubicin

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

DRUGCisplatin

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

DRUGGemcitabine

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame
Overall response rate	Objective responses confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) (on 3rd and 6th cycle)

Secondary

Measure	Time frame
Time to tumor progression	1-year
Overall survival	1-year
Toxicity profile	Toxicity assessment on each chemotherapy cycle

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026