Gall Bladder Disorders |
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Clinical Trial: Transurethral Resection and Combination Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer
This study is no longer recruiting patients.
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combination chemotherapy combined with transurethral resection may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of transurethral resection plus combination chemotherapy in treating patients who have stage II or stage III bladder cancer.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| stage III bladder cancer stage II bladder cancer childhood kidney/urinary cancer transitional cell carcinoma of the bladder | Drug: cisplatin Drug: doxorubicin Drug: filgrastim Drug: methotrexate Drug: vinblastine | Phase II |
MedlinePlus related topics: Bladder Cancer; Cancer
Genetics Home Reference related topics: bladder cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Thorough Transurethral Resection and Escalated Dose Methotrexate/Vinblastine/Doxorubicin/Cisplatin (M-VAC) in Patients with Transitional Cell Carcinoma of the Bladder
Study start: September 1998
OBJECTIVES: I. Determine the percentage of patients with transitional cell carcinoma of the bladder who are disease free or who have minimal disease 3 months after thorough transurethral resection (TURB) and escalated dose methotrexate/vinblastine/doxorubicin/cisplatin (M-VAC) chemotherapy. II. Evaluate the combination of thorough TURB and escalated dose M-VAC followed by radiotherapy with respect to bladder preservation for patients who respond to neoadjuvant chemotherapy. III. Evaluate the proportion of patients remaining disease free and not requiring cystectomy at 1 year. IV. Evaluate the feasibility and morbidity of this treatment schedule in multiple institutions applied by urologists of possibly varying endoscopic ability.
PROTOCOL OUTLINE: This is a multicenter study. Patients undergo a local transurethral resection. Patients then receive methotrexate IV on day 1, followed by vinblastine IV, doxorubicin IV, and cisplatin IV on day 2. Filgrastim (G-CSF) is administered on days 4-10. Chemotherapy is repeated every 14 days for 3 courses. After the end of chemotherapy, patients undergo another local transurethral resection in order to define response to treatment. Patients with minimal or no disease are treated with radiotherapy. Patients who still have disease undergo a cystectomy. Patients are followed every 3 months for the first 2 years, and then every 6 months until death.
PROJECTED ACCRUAL: A total of 29-73 patients will be accrued for this study.
Eligibility
Criteria
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Transitional cell carcinoma of the bladder with biopsy proven muscle invasion suitable for resection leaving no residual visible or palpable tumor mass; Unifocal; No greater than 5 cm; Stages II and III (T2-T3a, N0-NX, M0)
- No prior treatment for bladder cancer other than endoscopic resection, intravesical chemotherapy, or intravesical immunotherapy
--Prior/Concurrent Therapy--
- Biologic therapy: See Disease Characteristics
- Chemotherapy: See Disease Characteristics; No prior systemic chemotherapy
- Endocrine therapy: Not specified
- Radiotherapy: No prior radiotherapy to the bladder
- Surgery: See Disease Characteristics; No prior partial cystectomy; Prior transurethral resection of the bladder allowed
--Patient Characteristics--
- Age: Not specified
- Performance status: WHO 0-1
- Life expectancy: Not specified
- Hematopoietic: WBC at least 3,500/mm3; Platelet count at least 120,000/mm3
- Hepatic: Bilirubin normal SGOT/SGPT normal
- Renal: GFR at least 50 mL/min
- Cardiovascular: Normal cardiac function (i.e., no New York Heart Association class II-IV)
- Other: Normal auditory function; No second primary malignant tumor except basal cell carcinoma of the skin; Fit for cisplatin containing combination chemotherapy, radical radiotherapy, or cystectomy; No active infections; Not pregnant or nursing; No concurrent illness that significantly affects clinical assessments
Location Information
Italy
San Raffaele Hospital, Rome, 00144, Italy
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: May 2004
Last Updated: October 13, 2004
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00003640
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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