S0353, Gemcitabine in Treating Patients With Recurrent Bladder Cancer That Has Not Responded to Previous Bacillus Calmette-Guerin - Full Text View

Sponsor:	Southwest Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Southwest Oncology Group
ClinicalTrials.gov Identifier:	NCT00234039

Purpose

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine directly into the bladder may kill more tumor cells.

PURPOSE: This phase II trial is studying how well gemcitabine works in treating patients with recurrent bladder cancer that has progressed despite previous Bacillus Calmette-Guerin (BCG).

Condition	Intervention	Phase
Bladder Cancer	Drug: gemcitabine hydrochloride	Phase II

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Study of Intravesical Gemcitabine in Patients With Superficial Bladder Cancer Who Have Progressed Despite Intravesical BCG

Resource links provided by NLM:

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride BCG Vaccine

U.S. FDA Resources

Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:

Efficacy in terms of complete response rate [ Designated as safety issue: No ]
Recurrence-free, worsening-free, progression-free, and overall survival [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]
Correlation of expression levels of genes or genetic polymorphisms with clinical toxicity, response, and relapse-free survival [ Designated as safety issue: Yes ]

Estimated Enrollment:	45
Study Start Date:	November 2006

Detailed Description:

OBJECTIVES:

Determine the 8-12 week efficacy of intravesical gemcitabine, in terms of complete response rate, in patients with recurrent superficial transitional cell carcinoma of the bladder that have progressed despite prior intravesical Bacillus Calmette-Guerin (BCG).
Determine the recurrence-free, worsening-free, progression-free, and overall survival of patients treated with this drug.
Evaluate the toxicity of this drug in these patients.
Correlate, preliminarily, expression levels of genes or genetic polymorphisms involved in the gemcitabine pathway and angiogenesis with clinical toxicity, response, and relapse-free survival of patients treated with this drug.

OUTLINE: This is a multicenter study.

Induction therapy: Patients receive gemcitabine intravesically once a week for 6 weeks (weeks 1-6) in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response proceed to maintenance therapy at week 14.
Maintenance therapy: Patients receive gemcitabine intravesically once in weeks 14, 18, 22, 26, 30, 34, 38, 42, 46, and 50 in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 25-45 patients will be accrued for this study within 6-12 months.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed superficial transitional cell carcinoma (TCC) of the bladder meeting 1 of the following stage criteria:
- Stage T1, grade 2-3
- Stage Tis
- Stage Ta, grade 3-4 or multifocal (> 2 lesions)
Must have received and failed ≥ 2 courses of intravesical Bacillus Calmette-Guerin (BCG) (one 6-week course, plus one 3-week course, or fewer weeks if BCG was discontinued due to side effects) within the past 3 years
Recurrent disease
- Must have had a transurethral resection of the bladder tumor (TURBT) or bladder biopsy within the past 60 days documenting tumor recurrence and tumor stage and grade
  - TURBT or biopsy must have been performed ≥ 6 weeks after the completion of BCG and/or other immunotherapy treatment (or ≥ 14 days after completion of intravesical chemotherapy treatment)
  - All visible tumor must have been resected at the time of the last biopsy
No evidence of urethral or renal pelvis TCC by upper tract radiological imaging (e.g., intravenous pyelogram, CT urogram, or retrograde pyelogram) within the past 2 years

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Zubrod 0-2

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Other

Not pregnant or nursing
Fertile patients must use effective contraception
No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer that is in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

See Disease Characteristics
Prior intravesical interferon alfa allowed, alone or in combination with Bacillus Calmette-Guerin (BCG)

Chemotherapy

See Disease Characteristics
No more than 1 course of intravesical chemotherapy (e.g., thiotepa, mitomycin, or doxorubicin) within the past year, defined as 6 or more weekly instillations, with or without monthly maintenance instillations
No prior gemcitabine

Endocrine therapy

Not specified

Radiotherapy

No prior pelvic radiotherapy
No concurrent radiotherapy to any other area of the body

Surgery

See Disease Characteristics
Recovered from prior surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234039

Show 98 Study Locations

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Eila C. Skinner, MD

USC/Norris Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Laurence H. Baker, D.O., Chairman, SWOG
ClinicalTrials.gov Identifier:	NCT00234039 History of Changes
Other Study ID Numbers:	CDR0000446074, U10CA032102, SWOG-S0353
Study First Received:	October 5, 2005
Last Updated:	July 21, 2011
Health Authority:	United States: Federal Government

Keywords provided by Southwest Oncology Group:

recurrent bladder cancer
stage 0 bladder cancer
stage I bladder cancer
transitional cell carcinoma of the bladder

Additional relevant MeSH terms:

Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
BCG Vaccine
Gemcitabine
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on February 09, 2012