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Fenretinide in Treating Patients With Biochemically Recurrent Hormone-Naïve Prostate Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: California Cancer Consortium
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00080899
  Purpose

RATIONALE: Drugs used in chemotherapy, such as fenretinide, 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 fenretinide works in treating patients with biochemically (rising PSA level) recurrent hormone-naïve (no previous hormone therapy) prostate cancer.


Condition Intervention Phase
Prostate Cancer
Drug: fenretinide
Phase II

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Fenretinide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Trial Of Fenretinide (4-HPR) In Biochemically Recurrent, Hormone Naive Prostate Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Prostate-specific antigen response [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to clinical progression [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 37
Study Start Date: June 2004
Detailed Description:

OBJECTIVES:

  • Determine the prostate-specific antigen (PSA) response in patients with biochemically recurrent, hormone-naïve prostate cancer treated with fenretinide.
  • Determine the PSA doubling time and time to PSA progression in patients treated with this drug.
  • Determine the qualitative and quantitative toxic effects of this drug in these patients.
  • Determine the bioavailability of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to prior therapy (surgery vs radiotherapy and/or brachytherapy vs both), stage at diagnosis (organ confined vs extra-capsular extension vs lymph node positive), Gleason score at diagnosis (2-4 vs 5-6 vs 7-10), and prostate-specific antigen level at diagnosis (0-4 ng/mL vs 4.1-10 ng/mL vs > 10 ng/mL).

Patients receive oral fenretinide twice daily on days 1-7. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • Rising prostate-specific antigen (PSA) (absolute PSA value > 2.0 ng/mL above the nadir) after a nadir (< 4 ng/mL for post-radiotherapy patients and 0.3 ng/mL for post-prostatectomy patients) after local curative therapy (radical prostatectomy and/or pelvic irradiation)

    • Confirmed by 2 sequential PSA increases of at least 0.5 ng/mL each, taken ≥ 2 weeks apart
    • Absolute increase in PSA must be ≥ 2 ng/mL in patients who received prior radiotherapy
  • PSA ≥ 2 ng/mL
  • No clinical or radiographic evidence of metastatic or locally recurrent disease

    • CT scan or MRI of the chest/abdomen/pelvis AND bone scan negative for metastatic disease within the past 4 weeks

PATIENT CHARACTERISTICS:

Age

  • Not specified

Performance status

  • ECOG 0-2

Life expectancy

  • More than 3 months

Hematopoietic

  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 100,000/mm^3 (transfusion independent, defined as no transfusion within the past 3 weeks)
  • Hemoglobin ≥ 8.0 g/dL (transfusion or exogenous epoetin alfa allowed)

Hepatic

  • Bilirubin ≤ 1.5 mg/dL
  • AST and ALT < 2.5 times upper limit of normal

Renal

  • Creatinine ≤ 1.5 g/dL OR
  • Creatinine clearance or radioisotope glomerular filtration rate ≥ 50 mL/min

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other

  • Fertile patients must use effective contraception during and for at least 3 months after study participation
  • Able to swallow entire intact capsules
  • No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drug (i.e., retinoids)
  • No CNS toxicity > grade 3
  • No uncontrolled seizure disorder

    • Seizure disorders are allowed provided patient is on anticonvulsants and disorder is well controlled
  • No other concurrent uncontrolled illness
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ, or adequately treated stage I or II cancer currently in complete remission
  • No known retinopathy
  • No known uncontrolled hypertriglyceridemia resulting in pancreatitis

    • Triglycerides < 300 mg/dL

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior or concurrent biological response modifiers for recurrent prostate cancer

Chemotherapy

  • No prior cytotoxic chemotherapy
  • No prior chemotherapy for recurrent prostate cancer
  • No other concurrent anticancer chemotherapy

Endocrine therapy

  • Prior neoadjuvant or adjuvant hormone ablation therapy allowed provided it was administered in conjunction with primary definitive therapy ≤ 9 months in duration
  • No prior androgen ablative therapy
  • No prior or concurrent corticosteroids for recurrent prostate cancer
  • No prior or concurrent hormonal therapy for recurrent prostate cancer
  • At least 1 year since prior androgen deprivation
  • No concurrent tamoxifen
  • No concurrent hormone ablative agents (including steroids)

Radiotherapy

  • See Disease Characteristics
  • Prior adjuvant radiotherapy for positive margins or pT3 disease allowed
  • Prior radiotherapy allowed for local recurrence provided the patient has had a subsequent rise in PSA level from a nadir of < 4 ng/mL
  • No concurrent radiotherapy for persistent PSA or for local recurrence
  • No concurrent radiotherapy for recurrent prostate cancer

Surgery

  • See Disease Characteristics

Other

  • No more than 1 prior investigational anticancer agent
  • No concurrent complementary or alternative therapy (e.g., Hypericum perforatum [St. John's wort], PC-SPES, or any other herbal remedies) for prostate cancer
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent drugs suspected of causing pseudotumor cerebri (e.g., tetracycline, nalidixic acid, nitrofurantoin, phenytoin, sulfonamides, lithium, amiodarone, or vitamin A)
  • No concurrent drugs that modulate intracellular ceramide levels, ceramide cytotoxicity, sphingolipid transport, or p-glycoprotein or multidrug resistance-associated protein-1 drug/lipid transporters (e.g., cyclosporine, verapamil, ketoconazole, chlorpromazine, mifepristone, indomethacin, or sulfinpyrazone)
  • No concurrent antioxidant supplements (e.g., ascorbic acid or vitamin E)
  • No concurrent participation in another therapeutic clinical trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00080899

Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Tower Cancer Research Foundation
Beverly Hills, California, United States, 90211
University of California Davis Cancer Center
Sacramento, California, United States, 95817
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
United States, Pennsylvania
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
California Cancer Consortium
Investigators
Study Chair: Jacek Pinski, MD Norris Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000357312, CCC-PHII-47, NCI-6168
Study First Received: April 7, 2004
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00080899  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
recurrent prostate cancer
stage II prostate cancer
stage III prostate cancer

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Fenretinide
Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms
Recurrence

Additional relevant MeSH terms:
Anticarcinogenic Agents
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009