Gemcitabine, Paclitaxel, and Cisplatin in Treating Patients With Advanced Cancer of the Urothelium

August 8, 2018 updated by: Wake Forest University Health Sciences

A Phase II Trial of Gemzar (Gemcitabine), Taxol (Paclitaxel), and Platinol (Cisplatin) (GTP) in Treatment of Advanced Transitional Cell Carcinoma of the Urothelium

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, paclitaxel, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with paclitaxel and cisplatin works in treating patients with advanced transitional cell cancer of the urothelium.

Study Overview

Detailed Description

OBJECTIVES:

  • Determine response to gemcitabine hydrochloride, paclitaxel, and cisplatin (GTP) among patients with regional or distant metastases of transitional cell carcinoma of the urothelium or local/regional recurrence after cystoprostatectomy.
  • Determine response in patients who receive GTP as the initial chemotherapeutic treatment as well as in patients who have received prior chemotherapy.
  • Determine response duration, freedom from progression, and overall survival.
  • Assess the toxicity of GTP.

OUTLINE: This is an open-label study. Patients are stratified according to prior chemotherapy (yes vs no).

Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Patients achieving a partial response or complete response undergo surgical restaging and debulking. Four to 6 weeks later, patients receive 2 additional courses of chemotherapy.

After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 71 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Anticipated)

71

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Carolina
      • Charlotte, North Carolina, United States, 28203-4239
        • Carolinas Hematology-Oncology Associates
      • Greensboro, North Carolina, United States, 27403-1199
        • Regional Cancer Center
      • Winston-Salem, North Carolina, United States, 27157-1096
        • Wake Forest University Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed transitional cell carcinoma (TCC) of the urothelium (bladder, renal pelvis, or ureter) or TCC with squamous or glandular elements

    • No pure squamous cell carcinoma or adenocarcinoma
  • Disease not amenable to local curative treatment
  • Regional or distant metastases of TCC of the urothelium OR local/regional recurrence after cystectomy, cystoprostatectomy, nephroureterectomy, or ureterectomy

    • If regional metastases present alone, histological confirmation of the metastases is required
  • No clinically evident brain metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0 or 1
  • Granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10 g/dL
  • Creatinine ≤ 1.6 mg/mL
  • Bilirubin ≤ 1.8 mg/mL
  • SGOT ≤ 3 times upper limit of normal
  • Life expectancy > 3 months
  • No known sensitivity to E. coli-derived products
  • No other prior or concurrent malignancy except active/inactive nonmelanoma skin cancer, adequately treated stage I or II cancer currently in complete remission, or observation-only early-stage prostate cancer
  • No other serious medical illness that would limit survival to < 3 months
  • No psychiatric condition that would limit compliance with study requirements
  • No active uncontrolled bacterial, viral, or fungal infection unless corrected or controlled
  • No hemorrhagic disorder
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior systemic chemotherapy regimen
  • Prior intravesical therapy allowed
  • Prior definitive radiation to renal pelvis, ureter, or bladder allowed
  • No concurrent chemotherapy with nonstudy drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Toxicity
Overall survival
Response duration
Response
Freedom from progression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Frank M. Torti, MD, MPH, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1998

Primary Completion (Actual)

October 1, 2005

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

March 29, 2006

First Submitted That Met QC Criteria

March 29, 2006

First Posted (Estimate)

April 3, 2006

Study Record Updates

Last Update Posted (Actual)

August 10, 2018

Last Update Submitted That Met QC Criteria

August 8, 2018

Last Verified

August 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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