S0400, FR901228 in Treating Patients With Advanced Cancer of the Urothelium
This study has been terminated.
(Permanently Closed Due to Poor Accrual)
Sponsor:
Southwest Oncology Group
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00087295
First received: July 8, 2004
Last updated: October 31, 2012
Last verified: October 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
RATIONALE: Drugs used in chemotherapy, such as FR901228 (depsipeptide), work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well FR901228 works in treating patients with advanced cancer of the urothelium that has progressed or recurred after receiving one chemotherapy regimen.
| Condition | Intervention | Phase |
|---|---|---|
|
Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer |
Drug: Depsipeptide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Depsipeptide (NSC-630176) In Patients With Advanced Transitional Cell Carcinoma Of The Urinary Tract Who Have Progressed After Receiving One Prior Chemotherapy Regimen For Advanced Disease |
Resource links provided by NLM:
Genetics Home Reference related topics:
bladder cancer
Drug Information available for:
Romidepsin
U.S. FDA Resources
Further study details as provided by Southwest Oncology Group:
Primary Outcome Measures:
- Probability of response (confirmed complete and partial) [ Time Frame: From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Progression-free survival [ Time Frame: From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years ] [ Designated as safety issue: No ]
- Number and grade of adverse events [ Time Frame: From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 6 |
| Study Start Date: | June 2004 |
| Study Completion Date: | April 2006 |
| Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment
Depsipeptide
|
Drug: Depsipeptide
Depsipeptide wil be given 13 mg/m^2 through an intravenous (IV) over 4 hours on day 1, 8, and 15 for every 28 days (1 cycle = 28 days) until progression. Patients achieving a complete response (CR) will receive two additional cycles of treatment, and then be removed from protocol treatment.
Other Names:
|
Detailed Description:
OBJECTIVES:
- Determine the response (confirmed complete and partial) in patients with advanced transitional cell carcinoma of the urothelium that has progressed after prior chemotherapy when treated with FR901228 (depsipeptide) .
- Determine progression-free and overall survival of patients treated with this drug.
- Determine the qualitative and quantitative toxic effects of this drug in these patients.
- Determine, preliminarily, the effects of this drug on reversing tumor promoter gene methylation in these patients.
- Correlate, preliminarily, tumor DNA in plasma with response or outcome in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response receive 2 additional courses of treatment.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed transitional cell carcinoma of the urothelium (bladder, renal pelvis, ureter, or urethra)
Metastatic disease
- Node-positive, non-metastatic disease that is unresectable is allowed
- Poorly differentiated transitional cell carcinoma OR predominant transitional cell carcinoma with rare foci of squamous differentiation or rare foci of adenocarcinoma allowed
The following histologic types are not allowed:
- Adenocarcinoma
- Small cell carcinoma
- Sarcoma
- Squamous cell carcinoma
- Mixed adeno/squamous/transitional histology
Measurable disease
- At least 1 unidimensionally measurable lesion ≥ 2 cm by conventional techniques OR ≥ 1 cm by spiral CT scan
- Soft tissue disease irradiated within the past 2 months is not considered measurable
- Disease progression or recurrence after 1, and only 1, prior systemic chemotherapy regimen that included cisplatin or carboplatin for metastatic disease
- Not curable by surgery or radiotherapy
- No known brain metastases
PATIENT CHARACTERISTICS:
Age
- Not specified
Performance status
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- White blood cell (WBC) count ≥ 3,000/mm^3
Hepatic
- Aspartate aminotransferase (SGOT) / alanine aminotransferase (SGPT) ≤ 2.5 times upper limit of normal (ULN)
- Bilirubin normal
Renal
- Creatinine ≤ 2 times ULN
Cardiovascular
- Corrected QT interval (QTc) < 500 msec
- Left ventricular ejection fraction (LVEF) > 40% by Multi Gated Acquisition Scan (MUGA)
- No New York Heart Association class III or IV congestive heart failure
- No myocardial infarction within the past year
- No uncontrolled dysrhythmias
- No poorly controlled angina
- No serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
- No left ventricular hypertrophy on EKG
- No other significant cardiac disease
Other
- Potassium ≥ 4 mmol/L
- Magnesium ≥ 2 mg/dL
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No prior allergic reaction to compounds of similar chemical or biological composition to FR901228 (depsipeptide)
- 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 in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent immunotherapy
Chemotherapy
- See Disease Characteristics
- At least 28 days since prior chemotherapy
- No prior FR901228 (depsipeptide)
- No other concurrent chemotherapy
Endocrine therapy
- No concurrent hormonal therapy
Radiotherapy
- See Disease Characteristics
- More than 28 days since prior radiotherapy
- No concurrent radiotherapy
Surgery
- More than 28 days since prior surgery
Other
- Recovered from all prior therapy
- More than 28 days since prior intravesical therapy
- No concurrent hydrochlorothiazide
- No concurrent agent that causes QTc prolongation
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent investigational histone deacetylase inhibitor agents or drugs (e.g., sodium valproate)
- No other concurrent anticancer therapy
Contacts and Locations More Information
No publications provided
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00087295 History of Changes |
| Other Study ID Numbers: | CDR0000373886, U10CA032102, S0400 |
| Study First Received: | July 8, 2004 |
| Last Updated: | October 31, 2012 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration |
Keywords provided by Southwest Oncology Group:
|
recurrent bladder cancer stage IV bladder cancer transitional cell carcinoma of the bladder metastatic transitional cell cancer of the renal pelvis and ureter recurrent transitional cell cancer of the renal pelvis and ureter |
anterior urethral cancer posterior urethral cancer recurrent urethral cancer urethral cancer associated with invasive bladder cancer |
Additional relevant MeSH terms:
|
Urinary Bladder Neoplasms Carcinoma, Transitional Cell Urethral Neoplasms Kidney Neoplasms Ureteral Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases |
Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Urethral Diseases Kidney Diseases Ureteral Diseases Romidepsin Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013