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Bladder CancerPhase 2NCT00003129

Chemotherapy in Treating Patients With Early-Stage Bladder Cancer

A Phase 2 study testing valrubicin in people with Bladder Cancer, run by Eastern Cooperative Oncology Group at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of chemotherapy in treating patients with early-stage bladder cancer that has not responded to BCG therapy. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Bladder Cancer
What is being tested?
valrubicin
How many people
75 participants
Where
10 sitesUnited States
Study dates
1 Sep 1998to 1 May 2009
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 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed recurrent superficial bladder cancer defined as papillary transitional cell carcinoma (stage Ta/T1) and/or carcinoma in situ (stage Tis) of the urinary bladder
  • No evidence of invasion of the underlying muscle (stage T2) at baseline
  • Must meet 1 of the following criteria:
  • Failure of at least 2 prior courses of intravesical therapy, 1 of which must have been a course of BCG
  • Recurrent or persistent disease within 6 months after failing a 6-week course of BCG followed by maintenance therapy
  • Inability or ineligibility to complete 1 course of intravesical therapy with BCG, and failure of 2 prior courses of intravesical therapy with an alternative agent
  • Diagnosis must have been made no more than 24 months after completion of prior treatment with intravesical immunotherapy or chemotherapy
  • If carcinoma in situ is current or previous diagnosis, the biopsies must be obtained from at least 4 sites (bladder mapping)
  • If prostatic urothelial biopsy discloses carcinoma in situ, transurethral prostatic resection must be carried out prior to study
  • Papillary disease must have undergone complete transurethral resection (TURBT) within 28 days before study

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC greater than 4,000/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic:

  • Bilirubin less than 2 times upper limit of normal (ULN)
  • SGOT and SGPT less than 3 times ULN

Renal:

  • Creatinine no greater than 2.5 mg/dL

Other:

  • Normal upper tract (ureter and renal pelvic) evaluation within 6 months
  • No known sensitivity to anthracyclines or to Cremophor EL
  • HIV negative
  • No known AIDS or HIV-1 associated complex
  • No other significant concurrent illness
  • No other prior malignancy within the past 3 years except superficial bladder cancer, adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • No concurrent biological response modifier therapy

Chemotherapy:

  • See Disease Characteristics
  • Prior oral bropirimine for bladder cancer allowed
  • No prior AD 32 for bladder cancer
  • No other intravenously administered systemic chemotherapy for bladder cancer
  • No concurrent chemotherapy for any other malignancy

Endocrine therapy:

  • No concurrent hormonal therapy

Radiotherapy:

  • No prior radiotherapy
  • No concurrent radiotherapy

Surgery:

  • See Disease Characteristics

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Veterans Affairs Medical Center - East Orange

    East Orange, New Jersey, 07018-1095

  • CCOP - Green Bay

    Green Bay, Wisconsin, 54301

  • Veterans Affairs Medical Center - Madison

    Madison, Wisconsin, 53705

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792-6164

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Veterans Affairs Medical Center - Milwaukee (Zablocki)

    Milwaukee, Wisconsin, 53295

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612-9497

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • CCOP - MainLine Health

    Wynnewood, Pennsylvania, 19096

Other trials in United States

About this study

Official title: Phase II Study of Intravesical Therapy With AD 32 in Patients With Papillary Urothelial Carcinoma or Carcinoma in Situ (CIS) Refractory to Prior Therapy With Bacillus Calmette-Guerin

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy in treating patients with early-stage bladder cancer that has not responded to BCG therapy.

Read the detailed description

OBJECTIVES:

  • Determine the recurrence rate and disease free survival in patients with recurrent or refractory papillary transitional cell carcinoma of the bladder with or without carcinoma in situ of the bladder treated with intravesical AD 32.
  • Evaluate the safety of administering this drug in these patients.
  • Determine the effectiveness of this drug, in terms of recurrence rates and disease free survival, in these patients.

OUTLINE: Patients are stratified according to cellular diagnosis (papillary transitional cell carcinoma (Ta/T1) with no carcinoma in situ (Tis) vs Tis with or without Ta/T1).

Patients receive intravesical AD 32 once a week for 6 weeks.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.

Conditions
Bladder Cancer
Being tested
valrubicin
Keywords
stage 0 bladder cancer, stage I bladder cancer, transitional cell carcinoma of the bladder
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

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

  • valrubicinDrug

Timeline

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

  1. First posted18 Apr 2003 (estimated)
  2. Study start1 Sep 1998
  3. Primary completionNov 2002
  4. Study completion1 May 2009

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
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003129
Sponsor's protocol ID
CDR0000065892
Other IDs
E-3897
Status last verified
Jun 2023
First submitted
1 Nov 1999
Last updated
22 Jun 2023
Results posted
No

Publications

  • Ignatoff JM, Chen YH, Greenberg RE, Pow-Sang JM, Messing EM, Wilding G. Phase II study of intravesical therapy with AD32 in patients with papillary urothelial carcinoma or carcinoma in situ (CIS) refractory to prior therapy with bacillus Calmette-Guerin (E3897): a trial of the Eastern Cooperative Oncology Group. Urol Oncol. 2009 Sep-Oct;27(5):496-501. doi: 10.1016/j.urolonc.2008.05.004. Epub 2008 Jul 17.

    PubMed 18639470

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing valrubicin in people with Bladder Cancer, run by Eastern Cooperative Oncology Group at 10 sites in United States.

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

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003129, which also lists 1 linked publication.

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 22 Jun 2023.

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