Tamoxifen in Treating Patients With Metastatic Bladder Cancer That Did Not Respond to Previous Chemotherapy
Recruitment status was Recruiting
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RATIONALE: Tamoxifen may slow the growth of tumor cells and may be an effective treatment for patients with metastatic bladder cancer that did not respond to previous chemotherapy.
PURPOSE: This phase II trial is studying how well tamoxifen works in treating patients with metastatic bladder cancer that did not respond to previous chemotherapy.
Condition | Intervention | Phase |
---|---|---|
Bladder Cancer |
Drug: tamoxifen citrate Other: immunohistochemistry staining method Other: laboratory biomarker analysis |
Phase 2 |
Study Type: | Interventional |
Study Design: | Primary Purpose: Treatment |
Official Title: | Phase II Study of Tamoxifen for Progressive Metastatic Bladder Cancer Following Previous Platinum-Based Chemotherapy |
- 4-month freedom from progression (stable disease, partial response, or complete response) [ Designated as safety issue: No ]
Estimated Enrollment: | 75 |
Study Start Date: | July 2005 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- To assess the 4-month freedom from progression in patients with progressive metastatic transitional cell carcinoma of the bladder treated with tamoxifen citrate.
Secondary
- To determine the objective response rate.
- To correlate response with estrogen-receptor status of the metastatic tumor.
- To collect data on the toxicity and safety profile of this regimen.
- To assess the overall survival.
OUTLINE: This is a multicenter study.
Patients receive oral tamoxifen citrate once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo tumor tissue and blood sample collection periodically for correlative studies. Tumor tissue samples are analyzed for tumor estrogen receptors a and b by immunohistochemical (IHC) staining. Tumor tissue and blood samples are stored for future correlative biomarker studies.
After completion of study treatment, patients are followed every 2 months for up to 6 months.
![](https://webarchive.library.unt.edu/web/20121019031259im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically confirmed transitional cell carcinoma of the bladder
Evidence of progressive metastatic disease that is unresectable
- Stage T4b, N1-3, or M1 disease
Must have received 1-2 prior systemic therapy regimens (chemotherapy, biological therapy, or both) that included at least one platinum-based chemotherapy regimen
- Prior perioperative chemotherapy (adjuvant/neoadjuvant therapy) is considered one regimen
- Bidimensionally measurable disease (including bone disease) of ≥ 10 mm on spiral CT scan or ≥ 20 mm on conventional CT scan
No uncontrolled CNS metastases
- CNS metastases that have been previously treated with radiotherapy are allowed if patient is off corticosteroids
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Bilirubin ≤ 2.0 mg/dL
- AST/ALT < 4 times upper limit of normal
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective barrier or other nonhormonal methods of contraception
- No New York Heart Association class III-IV cardiac disease (i.e., congestive heart failure or myocardial infarction within the past 6 months)
- No severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection)
- Not at high risk for deep vein thrombosis, as determined by the physician
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No more than 2 prior systemic therapy regimens, including chemotherapy and/or biological therapy
- More than 4 weeks since prior systemic therapy
- More than 2 weeks since prior major surgery
![](https://webarchive.library.unt.edu/web/20121019031259im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
United States, California | |
USC/Norris Comprehensive Cancer Center and Hospital | Recruiting |
Los Angeles, California, United States, 90089-9181 | |
Contact: Clinical Trials Office - USC/Norris Comprehensive Cancer Cente 323-865-0451 | |
United States, Texas | |
Dan L. Duncan Cancer Center at Baylor College of Medicine | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Clinical Trials Office - Dan L. Duncan Cancer Center at Baylor 713-798-1297 | |
Methodist Hospital | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Joy Banerjee 713-798-4479 | |
Veterans Affairs Medical Center - Houston | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Contact Person 713-794-7111 | |
Italy | |
Azienda Ospedaliera S. Camillo-Forlanini | Recruiting |
Rome, Italy, 00152 | |
Contact: Cora N. Sternberg, MD, FACP 39-06-5870-4580 cstern@mclink.it |
Study Chair: | Seth P. Lerner, MD | Baylor College of Medicine |
![](https://webarchive.library.unt.edu/web/20121019031259im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Additional Information:
No publications provided
Responsible Party: | Seth P. Lerner, Dan L. Duncan Cancer Center at Baylor College of Medicine |
ClinicalTrials.gov Identifier: | NCT00589017 History of Changes |
Other Study ID Numbers: | CDR0000581181, BCM-H16848 |
Study First Received: | December 21, 2007 |
Last Updated: | July 7, 2009 |
Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
stage IV bladder cancer transitional cell carcinoma of the bladder recurrent bladder cancer |
Additional relevant MeSH terms:
Urinary Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Tamoxifen Antineoplastic Agents, Hormonal Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Bone Density Conservation Agents Estrogen Antagonists |
ClinicalTrials.gov processed this record on October 17, 2012