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Home > "F" Clinical Trials Conditions > Fenretinide in Treating Patients With Recurrent or Metastatic Head and Neck Cancer  Fenretinide in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Fenretinide in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
For Condition: Throat Cancer,Oral Cancer,Neck Cancer
Status: No longer recruiting
Sponsor(s): M.D. Anderson Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of fenretinide in treating patients who have recurrent or metastatic head and neck cancer.
Details: OBJECTIVES: - Determine the response rate, time to progression, median survival, and percent of 1-year survival in patients with recurrent or metastatic squamous cell carcinoma of the head and neck treated with fenretinide. - Determine the pharmacokinetics and safety of this drug in these patients. OUTLINE: Patients receive oral fenretinide every 12 hours on days 1-7. Treatment repeats every 3 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response continue treatment for 1 year. PROJECTED ACCRUAL: A total of 16-35 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of recurrent or metastatic squamous cell carcinoma of the head and neck PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Zubrod 0-2 Life expectancy: - At least 3 months Hematopoietic: - WBC at least 3,000/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9 g/dL Hepatic: - Transaminases no greater than 1.5 times normal - Bilirubin no greater than 1.5 times normal Renal: - Creatinine no greater than 1.5 mg/dL Other: - Not pregnant or nursing - Negative pregnancy test - Fertile female patients must use 2 methods of effective contraception, 1 barrier and 1 hormonal, for at least 4 weeks before, during, and for 1 month after study - Fertile male patients must use effective barrier contraception during and for 1 month after study - No grade 2 or greater peripheral neuropathy - No serious infection or other concurrent illness requiring immediate therapy - No other medical or social factors that would preclude compliance - Able to take oral medications PRIOR CONCURRENT THERAPY: Biologic therapy: - No more than 1 prior regimen of biologic therapy for metastatic disease - If initially received adjuvant or induction chemotherapy and then recurred, no more than 1 additional biologic therapy regimen at time of recurrence Chemotherapy: - See Biologic therapy - Prior induction chemotherapy or chemotherapy with radiotherapy allowed - No more than 1 prior chemotherapy regimen for metastatic disease - Any number of courses of a particular chemotherapy regimen allowed - If initially received adjuvant or induction chemotherapy and then recurred, no more than 1 additional chemotherapy regimen at time of recurrence - No other concurrent chemotherapy Endocrine therapy: - Not specified Radiotherapy: - See Chemotherapy - Prior radiotherapy allowed - No concurrent radiotherapy Surgery: - Prior surgery allowed Other: - No concurrent synthetic or natural vitamin A derivatives of 10,000 IU per day or more - No concurrent antioxidants (e.g., vitamin E or vitamin C)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BonnieGlisson, Study Chair, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Additional Information:
Study ID Numbers: CDR0000068294; NCI-610,MDA-ID-99334
Study Start Date:
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006471
Other Neck Cancer Studies:
1. Chemotherapy Plus Radiation Therapy in Treating Patients With Head and Neck Cancer
2. Fenretinide in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
3. SU5416 and Paclitaxel in Treating Patients With Recurrent, Locally Advanced or Metastatic Cancer of the Head and Neck
4. Liposomal Lurtotecan in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer
Related Studies:
Other Neck Cancer Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Fenretinide in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
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