Gemcitabine Hydrochloride and Cisplatin or High-Dose Methotrexate, Vinblastine, Doxorubicin Hydrochloride, and Cisplatin in Treating Patients With Urothelial Cancer
NCT ID: NCT01639521
Last Updated: 2014-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2013-05-31
2013-05-31
Brief Summary
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Detailed Description
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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.
SECONDARY OBJECTIVES
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 chemotherapy.
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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A (gemcitabine hydrochloride, cisplatin)
Patients receive cisplatin 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.
cisplatin
Given IV
gemcitabine hydrochloride
Given IV
laboratory biomarker analysis
Correlative studies
Arm B (MVAC)
Patients receive methotrexate IV on day 1 and vinblastine IV, doxorubicin hydrochloride IV, and cisplatin IV on day 2. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
cisplatin
Given IV
methotrexate
Given IV
vinblastine
Given IV
doxorubicin hydrochloride
Given IV
pegfilgrastim
Given SC
laboratory biomarker analysis
Correlative studies
Interventions
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cisplatin
Given IV
gemcitabine hydrochloride
Given IV
methotrexate
Given IV
vinblastine
Given IV
doxorubicin hydrochloride
Given IV
pegfilgrastim
Given SC
laboratory biomarker analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Southern California
OTHER
Responsible Party
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Principal Investigators
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Tanya Dorff
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Other Identifiers
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NCI-2012-00961
Identifier Type: REGISTRY
Identifier Source: secondary_id
4B-10-5
Identifier Type: -
Identifier Source: org_study_id
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