Gemcitabine, Paclitaxel, and Cisplatin in Treating Patients With Advanced Cancer of the Urothelium
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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 |
- 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) |
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 |
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| 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 | |
| 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 June 17, 2013