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Bladder CancerPhase 2NCT00087295

S0400, FR901228 in Treating Patients With Advanced Cancer of the Urothelium

A Phase 2 study testing Depsipeptide in people with Bladder Cancer and Transitional Cell Cancer of the Renal Pelvis and Ureter, run by SWOG Cancer Research Network.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Any age
What is being tested?
Depsipeptide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
No sites listed yet
Study dates
Jun 2004to Apr 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

About this study

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

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.

Read the 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.

Being tested
Depsipeptide
Keywords
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
Medical subject headings
Urinary Bladder Neoplasms, Urethral Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DepsipeptideDrug

    Also called FR901228, FK228

    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.

Study groups in NCT00087295
Study groupRoleWhat they receive
TreatmentExperimentalDepsipeptide
Receives: Drug: Depsipeptide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Probability of response (confirmed complete and partial)

    Measured: From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years

Secondary outcomes (3)

  1. Progression-free survival

    Measured: From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years

  2. Overall survival

    Measured: From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years

  3. Number and grade of adverse events

    Measured: From date of registration to progression or death from any cause, whichever came first, assessed up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2004 (estimated)
  2. Study startJun 2004
  3. Primary completionApr 2006
  4. Study completionApr 2006

Why it stopped: Permanently Closed Due to Poor Accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00087295
Sponsor's protocol ID
CDR0000373886
Other IDs
U10CA032102, S0400
Status last verified
Oct 2012
First submitted
8 Jul 2004
Last updated
2 Nov 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Depsipeptide in people with Bladder Cancer and Transitional Cell Cancer of the Renal Pelvis and Ureter, run by SWOG Cancer Research Network.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Permanently Closed Due to Poor Accrual). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00087295.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2012.

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