CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 23 enrolled
Drug / intervention
fenretinide +1 moredrug
Likely dose
Fenretinide orally; dose varies by body surface areaAI-extracted
Key inclusion· 6
  • ✓Histologically or cytologically confirmed adenocarcinoma of the prostate
  • ✓Rising PSA confirmed by two consecutive increases ≥2 weeks apart, with absolute PSA >2.0 ng/mL and increment ≥0.5 ng/mL above nadir (or ≥2 ng/mL for post-radiotherapy patients)
  • ✓Bone scan negative for metastatic disease within 4 weeks prior to registration
  • ✓ECOG performance status 0, 1, or 2
Key exclusion· 11
  • ✕Evidence of metastatic disease
  • ✕Prior cytotoxic chemotherapy or androgen ablative therapy (unless completed ≥1 year before registration; up to 9 months of neoadjuvant/adjuvant allowed with definitive therapy)
  • ✕Inability to take oral fenretinide
  • ✕History of allergic reactions to retinoids or structurally similar compounds

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00080899
NCT00080899Phase 2Completed
CompareCT.gov

A Phase II Trial of Fenretinide (4-HPR) in Biochemically Recurrent, Hormone Naive Prostate Cancer

National Cancer Institute (NCI)·interventional·Posted Apr 8, 2004·Updated Mar 6, 2015

In Brief

A Phase 2 clinical trial evaluating fenretinide and laboratory biomarker analysis for Adenocarcinoma of the Prostate and Recurrent Prostate Cancer. Completed, enrolled 23 participants across 1 site.

Detailed Summary

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. Drugs used in chemotherapy, such as fenretinide, work in different ways to stop tumor cells from dividing so they stop growing or die

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdenocarcinoma of the Prostate, Recurrent Prostate Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 8, 2004
Enrollment StartJun 1, 2004
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 22.2 years ago

Interventions

fenretinidedrug

Given orally

laboratory biomarker analysisother

Correlative studies