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

• Status: Terminated
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hellenic Oncology Research Group
• Collaborator: University Hospital of Crete
• Treatments: Cisplatin; Doxorubicin; Gemcitabine; Liposomal doxorubicin; Methotrexate; Vinblastine

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.