Fenretinide in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT00006471|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 30, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: Fenretinide||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Fenretinide in Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck|
|Study Start Date :||September 2000|
|Primary Completion Date :||July 2004|
|Study Completion Date :||July 2004|
1800 mg/m2 per day for seven consecutive days, in two divided doses of 900 mg/m2 12 hours apart, repeated every 3 weeks.
Other Name: 4-HPR
- To determine the response rate, time to progression, median survival, and percent one-year survival [ Time Frame: one-year survival ]To determine the response rate, time to progression, median survival, and percent one-year survival.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006471
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4009|
|Study Chair:||Bonnie S. Glisson, MD||M.D. Anderson Cancer Center|