Sequential High Dose MVAC (Methotrexate, Vinblastine, Doxorubicin and Cisplatin), Followed by Gemcitabine Plus Cisplatin in Treating Patients With Locally Advanced or Metastatic Bladder Cancer
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Enrollment
- 41
- Locations
- 7
- Primary Endpoint
- Overall response rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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-
- •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.
Arms & Interventions
1
MVAC -> GEM+CDDP
Intervention: Methotrexate (Drug)
1
MVAC -> GEM+CDDP
Intervention: Vinblastine (Drug)
1
MVAC -> GEM+CDDP
Intervention: Doxorubicin (Drug)
1
MVAC -> GEM+CDDP
Intervention: Cisplatin (Drug)
1
MVAC -> GEM+CDDP
Intervention: Gemcitabine (Drug)
Outcomes
Primary Outcomes
Overall response rate
Time Frame: Objective responses confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) (on 3rd and 6th cycle)
Secondary Outcomes
- Time to tumor progression(1-year)
- Overall survival(1-year)
- Toxicity profile(Toxicity assessment on each chemotherapy cycle)