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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00310011
First received: March 29, 2006
Last updated: June 4, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Bladder Cancer
Transitional Cell Cancer of the Renal Pelvis and Ureter
Drug: cisplatin
Drug: gemcitabine hydrochloride
Drug: paclitaxel
Procedure: conventional surgery
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Gemzar (Gemcitabine), Taxol (Paclitaxel), and Platinol (Cisplatin) (GTP) in Treatment of Advanced Transitional Cell Carcinoma of the Urothelium

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • Response [ Designated as safety issue: No ]
  • Response duration [ Designated as safety issue: No ]
  • Freedom from progression [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 71
Study Start Date: June 1998
Study Completion Date: August 2009
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00310011

Locations
United States, North Carolina
Carolinas Hematology-Oncology Associates
Charlotte, North Carolina, United States, 28203-4239
Regional Cancer Center
Greensboro, North Carolina, United States, 27403-1199
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Study Chair: Frank M. Torti, MD, MPH Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00310011     History of Changes
Other Study ID Numbers: CCCWFU-88197, CDR0000466059, CCCWFU-BG98-217, AMGEN-CCCWFU-88197
Study First Received: March 29, 2006
Last Updated: June 4, 2013
Health Authority: United States: Federal Government

Keywords provided by Comprehensive Cancer Center of Wake Forest University:
metastatic transitional cell cancer of the renal pelvis and ureter
recurrent transitional cell cancer of the renal pelvis and ureter
transitional cell carcinoma of the bladder
regional transitional cell cancer of the renal pelvis and ureter
stage IV bladder cancer
recurrent bladder cancer

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Kidney Neoplasms
Ureteral Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Diseases
Ureteral Diseases
Gemcitabine
Cisplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents

ClinicalTrials.gov processed this record on July 22, 2014