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

Hellenic Oncology Research Group

Status and phase

Terminated

Phase 2

Conditions

Bladder Cancer

Treatments

Drug: Methotrexate

Drug: Doxorubicin

Drug: Gemcitabine

Drug: Vinblastine

Drug: Cisplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00635726

CT/07.16

Details and patient eligibility

About

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.

Full 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.

Enrollment

41 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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.