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

NCT01639521 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2014-01-29

No results posted yet for this study

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.

Conditions

  • Anterior Urethral Cancer
  • Localized Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Posterior Urethral Cancer
  • Recurrent Bladder Cancer
  • Recurrent Urethral Cancer
  • Regional Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Stage III Bladder Cancer
  • Transitional Cell Carcinoma of the Bladder
  • Ureter Cancer
  • Urethral Cancer Associated With Invasive Bladder Cancer

Interventions

DRUG

cisplatin

Given IV

DRUG

gemcitabine hydrochloride

Given IV

DRUG

methotrexate

Given IV

DRUG

vinblastine

Given IV

DRUG

doxorubicin hydrochloride

Given IV

BIOLOGICAL

pegfilgrastim

Given SC

OTHER

laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Southern California

    lead OTHER

Principal Investigators

  • Tanya Dorff · University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2013-05-31
Completion
2013-05-31

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01639521 on ClinicalTrials.gov