S0353, Gemcitabine in Treating Patients With Recurrent Bladder Cancer That Has Not Responded to Previous Bacillus Calmette-Guerin
This study is ongoing, but not recruiting participants.
Sponsor:
Southwest Oncology Group
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00234039
First received: October 5, 2005
Last updated: November 19, 2012
Last verified: November 2012
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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 2 |
| 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:
Further study details as provided by Southwest Oncology Group:
Primary Outcome Measures:
- Complete Response Rate at the End of Induction [ Time Frame: Week 8-12, then every 3 months for the first 2 years, and then every 6 months for the years 3-5 ] [ Designated as safety issue: No ]Complete Response is defined as negative cystoscopy with negative biopsy and no evidence of cancer on urine cytology at the Week 8 - 12 cystoscopy
Secondary Outcome Measures:
- Overall Survival (OS) [ Time Frame: 1 year ] [ Designated as safety issue: No ]Measured from the day of registration to death due to any cause. Survival is censored at date of last contact.
- Recurrence-free Survival (RFS) [ Time Frame: 1 year ] [ Designated as safety issue: No ]Recurrence-free Survival is defined as time from registration to first instance of disease recurrence, or death due to any cause.
- Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug [ Time Frame: Patients were assessed for adverse events weekly for 6 weeks and then every 4 weeks for 40 weeks ] [ Designated as safety issue: Yes ]Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
| Enrollment: | 58 |
| Study Start Date: | November 2006 |
| Estimated Study Completion Date: | February 2014 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Intravesical Gemcitabine | Drug: gemcitabine hydrochloride |
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
Show 98 Study LocationsSponsors and Collaborators
Southwest Oncology Group
Investigators
| Study Chair: | Eila C. Skinner, MD | USC/Norris Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00234039 History of Changes |
| Other Study ID Numbers: | CDR0000446074, U10CA032102, SWOG-S0353 |
| Study First Received: | October 5, 2005 |
| Results First Received: | November 19, 2012 |
| Last Updated: | November 19, 2012 |
| 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 May 19, 2013