Randomized Phase II Trial Of Adjuvant Chemotherapy For Urothelial Carcinoma Comparing GC To Dose-Dense MVAC
To estimate the difference in the rate of unacceptable toxicity for dose-dense methotrexate,
vinblastine, doxorubicin, and cisplatin (MVAC) and gemcitabine and cisplatin (GC) in the
adjuvant treatment of urothelial cancer.
To compare rates of disease recurrence at 3 years between dose-dense MVAC and GC.
To determine whether molecular markers excision repair cross-complementing-1 (ERCC-1)
ribonucleoside-diphosphate reductase M-1 (RRM-1), breast cancer 1 (BRCA1) topoisomerase
2-alpha (Top2A) and protein 53 (p53) can predict those patients more likely to benefit from
To investigate the potential utility of cytidine deaminase (CDA), ERCC-1, xeroderma
pigmentosum group D (XPD), glutathione S-transferase P-1 (GSTP-1) and glutathione
S-transferase M-1 (GSTM-1) as molecular markers which predict occurrence of significant
toxicity during adjuvant chemotherapy for urothelial cancer.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients receive cisplatin intravenously (IV) on day 1 and gemcitabine hydrochloride
IV over 1 hour on days 1 and 8. Treatment repeats every 21 days for 4 courses in the absence
of disease progression or unacceptable toxicity.
ARM B: Patients receive methotrexate IV on day 1, vinblastine IV, doxorubicin hydrochloride
IV, cisplatin IV on day 2 and pegfilgrastim subcutaneously (SC) on day 3. Treatment repeats
every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 3 years.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of unacceptable toxicity graded according to Common Terminology Criteria (CTC) v4.0
80% confidence intervals (CI) will be constructed; for unacceptable toxicity, the confidence interval will be one-sided.
Assessed up to 3 years
USC/Norris Comprehensive Cancer Center
United States: Institutional Review Board