Gemcitabine Hydrochloride and Cisplatin or High-Dose Methotrexate, Vinblastine, Doxorubicin Hydrochloride, and Cisplatin in Treating Patients With Urothelial Cancer

• Status: Withdrawn
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is about two chemotherapy study drug combinations (regimens) that are used for urothelial (bladder or upper urinary tract) cancer. Both study drug regimens, gemcitabine (gemcitabine hydrochloride) plus cisplatin, and high-dose-intensity MVAC (methotrexate, vinblastine, doxorubicin plus cisplatin), are standard chemotherapy regimens. Both regimens are used to treat people with urothelial cancer that has spread to other organs. Both study drug regimens have been proven to be effective in lowering the risk of the cancer coming back, but it is not known which regimen is the best. This study hopes to learn whether there is a difference in the effectiveness and side effects of these two study drug regimens when they are given to people who have had their urothelial cancer completely removed.

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

Details

• Lead Sponsor: University of Southern California
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cisplatin; Doxorubicin; Gemcitabine; Liposomal doxorubicin; Methotrexate; Vinblastine

Criteria

Inclusion Criteria:

• Histologically confirmed high-grade urothelial carcinoma, stage T3bN0, T4N0 or any T stage with lymph node involvement, completely resected; including upper tract urothelial carcinoma

• The dominant histology must be transitional cell or urothelial but foci of other histologies less than 20 percent of the total tumor volume are permitted

• Absence of metastatic disease on radiographic imaging

• Patients must be enrolled and able to start treatment within 90 days of radical cystectomy or radical nephrectomy

• Creatinine less than institutional upper limit of normal (ULN) or clearance greater or equal to 50 mL/min (may be calculated by Cockcroft-Gault formula or measured from 24-hour urine collection)

• Serum total bilirubin less or equal to 1.5 x ULN (except for patients with Gilbert's)

• Alkaline phosphatase less or equal to 2.5 x ULN

• Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvate transaminase (SGPT) less or equal to 2.5 x ULN

• White blood cells (WBC) greater or equal to 3000

• Absolute neutrophil count (ANC) greater or equal to 1500

• Hemoglobin (Hb) greater or equal to 9

• Platelets greater or equal to 100,000

• Normal left ventricular ejection fraction, by echocardiogram or multi gated acquisition scan (MUGA)

• Patients must be recovered from surgery

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

• Willing and able to provide informed consent

• Willingness to use barrier contraception during study period

Exclusion Criteria:

• The presence of significant pleural effusion or ascites

• Prior systemic chemotherapy for urothelial carcinoma including neoadjuvant chemotherapy (prior intravesical therapy is permitted)

• History of malignancy within preceding 5 years, aside from non-melanoma skin cancer or previously treated or incidentally detected prostate cancer with undetectable PSA (after radical cystectomy or prostate cancer therapy)

• Peripheral neuropathy greater than grade 1

• The presence of active heart disease such as congestive heart failure or unstable angina