Bladder CancerPhase 3NCT00004154
Fenretinide in Treating Patients Who Have Undergone Surgery for Bladder Cancer
A Phase 3 study testing Fenretinide in people with Bladder Cancer, run by M.D. Anderson Cancer Center at 3 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as fenretinide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Fenretinide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Jul 1998to 1 Mar 2005
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically proven solitary or multifocal superficial (stage Ta, grades 1-2) transitional cell carcinoma (TCC) of the bladder meeting 1 of the following criteria:
- Newly diagnosed and no more than 4 weeks since resection
- Secondary after being tumor free (including carcinoma in situ) for more than 12 months with no intravesical therapy within that 12 months OR
- Histologically proven Ta, T1, or Tis TCC of the bladder previously treated with Bacillus Calmette-Guerin (BCG).
- Must have received 6 weeks of induction BCG followed by no evidence of disease by cystoscopy and cytology and then further treatment with 3 weekly doses of BCG.
- Visible tumor totally resected within 4 weeks prior to study entry and no further surgery, intravesical therapy, or systemic therapy planned
- No prostatic, prostatic urethral, or upper tract TCC involvement by the index tumor at resection
- No metastatic disease
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Zubrod (Eastern Cooperative Oncology Group (ECOG)) 0-2
Life expectancy:
- At least 2 years
Hematopoietic:
- white blood count (WBC) greater than 3,000/mm^3
- Platelet count greater than 100,000/mm^3
- Hemoglobin greater than 11.0 g/dL
Hepatic:
- serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) less than 1.5 times upper limit of normal (ULN)
Renal:
- Creatinine less than 2.0 mg/dL
Other:
- Triglyceride level less than 2.5 times ULN
- No other concurrent malignancy except nonmelanomatous skin cancer
- No other malignancy within the past 5 years unless currently disease free, at least 6 months since prior therapy, no current or planned active therapy, and expected disease-free survival at least 2 years
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 1 year after the study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
- No concurrent systemic biologic therapy
Chemotherapy:
- See Disease Characteristics
- No prior systemic cytotoxic chemotherapy for bladder cancer
- At least 1 year since prior cytotoxic chemotherapy for nonbladder cancer
- No concurrent systemic chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy to the bladder
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
Other:
- At least 3 months since prior high-dose vitamin A (greater than 25,000 IU) or beta carotene (at least 30 mg/day)
- At least 3 months since prior retinoid therapy
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
Baylor College of Medicine
Houston, Texas, 77030
Veterans Affairs Medical Center - Seattle
Seattle, Washington, 98108
About this study
Official title: Randomized Chemoprevention Trial With 4-HPR (Fenretinide) in Superficial Bladder Cancer
RATIONALE: Drugs used in chemotherapy, such as fenretinide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether fenretinide is more effective than a placebo in preventing the recurrence of bladder cancer after surgery to remove the tumor.
PURPOSE: This randomized phase III trial is studying fenretinide to see how well it works compared to a placebo in treating patients who are at risk for recurrent bladder cancer following surgery to remove the tumor.
Read the detailed description
OBJECTIVES:
- Determine the efficacy, mechanism of action, and toxicity of fenretinide in patients at risk of recurrent superficial bladder cancer after complete resection of initial tumor.
- Determine the treatment effects in modulating the expression of retinoid receptors, chromosomal abnormalities (numerical chromosomal abnormalities and DNA ploidy), apoptosis, and autocrine motility factor receptor (intermediate endpoint markers of recurrent disease) in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to lesion type (multifocal vs solitary). Patients are randomized to one of two treatment arms.
Patients receive either oral fenretinide or placebo on days 1-25. Courses repeat every 28 days for up to 1 year in the absence of disease progression, unacceptable toxicity, or development of a second primary cancer requiring therapy.
Patients are followed every 3 months for 15 months.
PROJECTED ACCRUAL: A total of 178 patients (89 per arm) will be accrued for this study.
- Conditions
- Bladder Cancer
- Being tested
- Fenretinide, Placebo
- 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.
FenretinideDrug
Also called 4-HPR
200 mg/day (two 100 mg capsules) for 25 days of 28 day cycle.
PlaceboOther
Two placebo capsules for 25 days of 28 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Fenretinide | Experimental | Fenretinide (4-HPR) 200 mg orally every day for 12 months taken 25 out of every 28 days. Receives: Drug: Fenretinide |
| Placebo | Placebo comparator | Placebo orally every day for 12 months, taken 25 out of every 28 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate of transitional cell carcinoma (TCC)
Recurrence rates is defined as proportion of participants who recur within one year of surgery.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study start30 Jul 1998
- Primary completion1 Mar 2005
- Study completion1 Mar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Anita L. Sabichi, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004154
- Sponsor's protocol ID
- CDR0000067387
- Other IDs
- MDA-ID-95236, NCI-G99-1621, NCI-T98-0051, ID95-236
- Status last verified
- Nov 2018
- First submitted
- 10 Dec 1999
- Last updated
- 8 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sabichi AL, Lerner SP, Atkinson EN, Grossman HB, Caraway NP, Dinney CP, Penson DF, Matin S, Kamat A, Pisters LL, Lin DW, Katz RL, Brenner DE, Hemstreet GP 3rd, Wargo M, Bleyer A, Sanders WH, Clifford JL, Parnes HL, Lippman SM. Phase III prevention trial of fenretinide in patients with resected non-muscle-invasive bladder cancer. Clin Cancer Res. 2008 Jan 1;14(1):224-9. doi: 10.1158/1078-0432.CCR-07-0733.
PubMed 18172274
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Chemoprevention Trial With 4-HPR (Fenretinide) in Superficial Bladder Cancer
- ClinicalTrials.gov ID
- NCT00004154
- Acronym / sponsor ID
- CDR0000067387
- Conditions
- Bladder Cancer
- Keywords
- stage 0 bladder cancer, stage I bladder cancer, transitional cell carcinoma of the bladder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 30 Jul 1998 (actual)
- Primary completion
- 1 Mar 2005 (actual)
- Study completion
- 1 Mar 2005 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as fenretinide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether fenretinide is more effective than a placebo in preventing the recurrence of bladder cancer after surgery to remove the tumor.
PURPOSE: This randomized phase III trial is studying fenretinide to see how well it works compared to a placebo in treating patients who are at risk for recurrent bladder cancer following surgery to remove the tumor.
Detailed description
OBJECTIVES:
- Determine the efficacy, mechanism of action, and toxicity of fenretinide in patients at risk of recurrent superficial bladder cancer after complete resection of initial tumor.
- Determine the treatment effects in modulating the expression of retinoid receptors, chromosomal abnormalities (numerical chromosomal abnormalities and DNA ploidy), apoptosis, and autocrine motility factor receptor (intermediate endpoint markers of recurrent disease) in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to lesion type (multifocal vs solitary). Patients are randomized to one of two treatment arms.
Patients receive either oral fenretinide or placebo on days 1-25. Courses repeat every 28 days for up to 1 year in the absence of disease progression, unacceptable toxicity, or development of a second primary cancer requiring therapy.
Patients are followed every 3 months for 15 months.
PROJECTED ACCRUAL: A total of 178 patients (89 per arm) will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fenretinide | Experimental | Drug: FenretinideFenretinide (4-HPR) 200 mg orally every day for 12 months taken 25 out of every 28 days. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo orally every day for 12 months, taken 25 out of every 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FenretinideAlso: 4-HPR200 mg/day (two 100 mg capsules) for 25 days of 28 day cycle. | Drug | Fenretinide |
| PlaceboTwo placebo capsules for 25 days of 28 day cycle. | Other | Placebo |
Primary outcome
Recurrence rate of transitional cell carcinoma (TCC)
Time frame: 1 year
Recurrence rates is defined as proportion of participants who recur within one year of surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
- Results publication: PubMed 18172274Sabichi AL, Lerner SP, Atkinson EN, Grossman HB, Caraway NP, Dinney CP, Penson DF, Matin S, Kamat A, Pisters LL, Lin DW, Katz RL, Brenner DE, Hemstreet GP 3rd, Wargo M, Bleyer A, Sanders WH, Clifford JL, Parnes HL, Lippman SM. Phase III prevention trial of fenretinide in patients with resected non-muscle-invasive bladder cancer. Clin Cancer Res. 2008 Jan 1;14(1):224-9. doi: 10.1158/1078-0432.CCR-07-0733.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anita L. Sabichi, MD study chair
M.D. Anderson Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fenretinide in people with Bladder Cancer, run by M.D. Anderson Cancer Center at 3 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 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
What does the primary outcome measure?
Recurrence rate of transitional cell carcinoma (TCC) (time frame: 1 year). 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 NCT00004154, 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 8 Nov 2018.