Back to Search
Start Over
Phase II trial of fenretinide in advanced renal carcinoma
- Source :
- Investigational New Drugs. 23:179-185
- Publication Year :
- 2005
- Publisher :
- Springer Science and Business Media LLC, 2005.
-
Abstract
- Purpose: Fenretinide, a synthetic form of retinoid, induced apoptosis even in chemotherapy resistant cell lines. A phase II study was hence conducted to evaluate toxicity and efficacy of fenretinide in metastatic renal cancer. Methods: Eligibility included unresectable or metastatic renal cell carcinoma (RCC), adequate organ function and Zubrod performance status ≦2. Prior immunotherapy and a maximum of one prior chemotherapy regimen were allowed. Fenretinide was administered at a dose of 900 mg/m2 twice daily orally for 7 days in a 21-day cycle. Toxicity was assessed at the start of each cycle, and response every 2 cycles. Results: Nineteen eligible patients enrolled of which fifteen had visceral/bone metastases. Seventeen patients had prior nephrectomy and 11 had prior immunotherapy. 76 cycles of therapy were delivered. Therapy was very well tolerated with few severe toxicities consisting of thrombosis in 1 individual and grade 3 fatigue, nausea and diarrhea in 1 patient. 5 patients had grade 2 nyctalopia and 3 patients had transient grade 2 visual toxicity. No objective responses were noted. Stable disease was seen in seven of nineteen cases (37%, 90% C.I. 0.21–0.59). Median time to progression was 1.5 months and median duration of stable disease was 5.8 months (90% C.I. 3.0–8.4). Median survival was 10 months. Tumor fenretinide levels were obtained in three patients and were in the lower end of the therapeutic range. Conclusion: Fenretinide was well tolerated but demonstrated minimal activity that was consistent with results of intratumoral drug measurements. Strategies are needed that will increase systemic and tumor levels of fenretinide.
- Subjects :
- Adult
Male
Oncology
medicine.medical_specialty
Fenretinide
Nausea
medicine.medical_treatment
Administration, Oral
Phases of clinical research
Antineoplastic Agents
chemistry.chemical_compound
Renal cell carcinoma
Internal medicine
medicine
Humans
Pharmacology (medical)
Aged
Pharmacology
business.industry
Middle Aged
medicine.disease
Chemotherapy regimen
Kidney Neoplasms
Nephrectomy
Surgery
Clinical trial
chemistry
Toxicity
Female
medicine.symptom
business
Subjects
Details
- ISSN :
- 15730646 and 01676997
- Volume :
- 23
- Database :
- OpenAIRE
- Journal :
- Investigational New Drugs
- Accession number :
- edsair.doi.dedup.....70763b7099c4d011c3d60abd3a282bde