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Fenretinide in Treating Patients With Biochemically Recurrent Hormone-Naïve Prostate Cancer
This study has been completed.
First Received: April 7, 2004   Last Updated: May 8, 2009   History of Changes
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

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

Resource links provided by NLM:


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
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
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 USC/Norris Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000357312, CCC-PHII-47, NCI-6168
Study First Received: April 7, 2004
Last Updated: May 8, 2009
ClinicalTrials.gov Identifier: NCT00080899     History of Changes
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:
Anticarcinogenic Agents
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Fenretinide
Genital Diseases, Male
Adenocarcinoma
Hormones
Prostatic Neoplasms
Recurrence

Additional relevant MeSH terms:
Anticarcinogenic Agents
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Genital Diseases, Male
Protective Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Fenretinide
Prostatic Neoplasms

ClinicalTrials.gov processed this record on September 10, 2009