S0219, Combination Chemotherapy Followed By Observation or Surgery in Patients With Stage II or Stage III Cancer of the Urothelium
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells and decrease the need for surgery.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by observation or surgery to remove the bladder (cystectomy) in treating patients who have stage II or stage III cancer of the urothelium.
| Condition | Intervention | Phase |
|---|---|---|
|
Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer |
Drug: carboplatin Drug: gemcitabine Drug: paclitaxel Procedure: surgery |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Sequential Approach to the Treatment of Muscle Invasive, Non-Metastatic Urothelial Carcinoma of the Bladder: A Phase II Trial of Neoadjuvant Gemcitabine, Paclitaxel and Carboplatin With Molecular Correlates |
- Pathologic complete response rate by transurethral resection of bladder tumor (TURBT) and imaging studies after chemotherapy [ Time Frame: assessed at end-of-study cystectomy ] [ Designated as safety issue: No ]
- Molecular markers predicting response and survival [ Time Frame: end of year 5 ] [ Designated as safety issue: No ]
- Evaluate recurrence rates and cystectomy-free survival [ Time Frame: every 6 months for 2 years, then annually for 5 years ] [ Designated as safety issue: No ]
- Evaluate survival [ Time Frame: every 6 months for 2 years, then annually for 5 years ] [ Designated as safety issue: No ]
- Assess toxicities [ Time Frame: weeks 1, 2, 4, 5, 7, 8, and following surgery ] [ Designated as safety issue: Yes ]
| Enrollment: | 77 |
| Study Start Date: | January 2003 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Gemcitabine, Paclitaxel, Carboplatin
Gemcitabine, Paclitaxel, Carboplatin followed by surgery
|
Drug: carboplatin
Drug: gemcitabine
Other Name: gemcitabine hydrochloride
Drug: paclitaxel
Other Name: Taxol
Procedure: surgery
|
Detailed Description:
OBJECTIVES:
- Determine the pathologic complete response of patients with stage II or III transitional cell cancer of the urothelium treated with neoadjuvant gemcitabine, paclitaxel, and carboplatin followed by observation or immediate cystectomy.
- Determine, preliminarily, if molecular markers predict response, survival, and tumor recurrence in patients treated with these regimens.
- Determine recurrence rates and cystectomy-free survival of patients who choose observation after an initial response to neoadjuvant chemotherapy.
- Compare the survival of patients treated with neoadjuvant chemotherapy followed by cystectomy vs observation.
- Determine the feasibility, tolerability, and toxicity of these regimens in these patients.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV over 30 minutes and paclitaxel IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Within 4-8 weeks after completion of neoadjuvant chemotherapy, patients undergo a third transurethral resection of bladder tumor.
Patients with T0 disease after neoadjuvant chemotherapy may choose to undergo observation. These patients undergo cystoscopies with biopsies every 3 months for 1 year, every 4 months for 1 year, and then every 6 months until disease progression.
Patients with T1 disease or greater after neoadjuvant chemotherapy undergo immediate cystectomy. Patients with T0 disease may also choose this option. Patients undergoing immediate cystectomy are followed every 6 months for 2 years and then annually for 3 years.
PROJECTED ACCRUAL: A total of 95 patients will be accrued for this study within 2 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically confirmed muscle-invasive (T2-T4a), node-negative (N0) urothelial transitional cell cancer (TCC) of the bladder
- Focal squamous and/or adenocarcinoma differentiation, defined as ≤ 10% of tumor volume allowed
The following diagnoses are not allowed:
- Small cell carcinoma
- Sarcomatoid components
Disease diagnosed with an initial transurethral resection of bladder tumor (TURBT) and a second TURBT performed within 8 weeks of first with attempt to remove all tumor present
- Residual disease after second TURBT allowed
- No more than 14-56 days after second TURBT
- No metastatic disease by chest x-ray and CT scan or MRI of the abdomen and pelvis
- Fresh tumor tissue, paraffin tumor tissue, unstained slides, or cell block specimen from one or both TURBTs available
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- WBC at least 3,500/mm^3
- Absolute granulocyte count at least 1,500/mm^3
- Platelet count at least lower limit of normal
Hepatic
- Bilirubin no greater than 1.5 mg/dL
- SGOT no greater than 2 times upper limit of normal
Renal
- Creatinine no greater than 2.0 mg/dL AND/OR
- Creatinine clearance at least 60 mL/min
Other
- No prohibitive medical risk that would preclude radical cystectomy
- No other serious concurrent systemic disorder that would preclude study compliance
- No other malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, adequately treated stage I or II cancer in complete remission, or any other cancer for which patient has been disease-free for 5 years
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Prior intravesical immunotherapy allowed
Chemotherapy
- No prior systemic chemotherapy for TCC of the urothelium
- Prior intravesical chemotherapy allowed
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy for TCC of the urothelium
- No concurrent radiotherapy
Surgery
- See Disease Characteristics
Contacts and Locations
Show 128 Study Locations| Study Chair: | Primo N. Lara, MD | University of California, Davis |
More Information
Additional Information:
Publications:
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00045630 History of Changes |
| Obsolete Identifiers: | NCT00191217 |
| Other Study ID Numbers: | CDR0000256921, S0219, U10CA032102 |
| Study First Received: | September 6, 2002 |
| Last Updated: | October 5, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Southwest Oncology Group:
|
anterior urethral cancer localized transitional cell cancer of the renal pelvis and ureter posterior urethral cancer stage II bladder cancer |
stage III bladder cancer transitional cell carcinoma of the bladder urethral cancer associated with invasive bladder cancer regional transitional cell cancer of the renal pelvis and ureter |
Additional relevant MeSH terms:
|
Urinary Bladder Neoplasms Urethral Neoplasms Carcinoma, Transitional Cell Kidney Neoplasms Ureteral Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Urethral Diseases Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Kidney Diseases Ureteral Diseases Gemcitabine Carboplatin Paclitaxel Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents |
ClinicalTrials.gov processed this record on May 23, 2013