Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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.

Further Study Information

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 Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Southwest Oncology Group

Primo N. Lara

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00045630
Information obtained from ClinicalTrials.gov on December 14, 2011

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