Fenretinide in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:

A Phase II Study of Fenretinide in Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006471
• Other study ID #: ID99-334
• Secondary ID: U01CA070172P30CA
• Status: Completed
• Phase: Phase 2
• Start date: September 2000
• Est. completion date: July 2004

Study information

• Verified date: October 2018
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: July 2004
• Est. primary completion date: July 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Biopsy-proven recurrent squamous cell carcinoma of the head and neck

2. Stage 4 disease, either at initial presentation or at recurrence. Patients with metastatic disease at initial presentation must have received at least one prior course of cytotoxic chemotherapy.

3. Patients who present with metastatic disease should have received no more than one prior regimen of chemotherapy or biologic therapy to be eligible. Patients who initially received adjuvant or induction chemotherapy and then recurred may have received one additional cycle of chemotherapy or biologic therapy at the time of recurrence. Patients may have received any number of cycles of a particular regimen of chemotherapy.

4. Patients must have a life expectancy of at least 3 months

5. Biopsy of the recurrent lesion(s) is encouraged but not mandatory for enrollment.

6. Performance status grade 0-2.

7. Serum creatinine <= 1.5 mg/dL.

8. Serum transaminases and bilirubin <= 1.5 time normal.

9. Age >= 18 years.

10. White blood cell count >= 3,000; platelets >= 100,000; hemoglobin >= 9mg/dl.

11. Signed informed consent.

12. Women of childbearing potential must agree to utilize two methods of effective birth control, one barrier, one hormonal, or should abstain from sexual intercourse that could result in pregnancy. Contraceptive measures should be continued for at least one month after fenretinide administration has been discontinued.

13. It is recommended that male patients with female partners of childbearing potential use barrier contraception while on fenretinide.

Exclusion Criteria:

1. Pregnant women (women of childbearing potential must have a negative pregnancy test within 24 hours prior to enrollment in the study); women who are currently breast-feeding.

2. Grade 2 or greater peripheral neuropathy

3. Concurrent treatment with cytotoxic chemotherapy or radiation

4. Serious infection or other intercurrent illness requiring immediate therapy.

5. Inability to take oral medications, or other medical or social factors interfering with compliance.

6. Patients on high dose synthetic or natural Vitamin A derivatives (>= 10,000 per day).

7. Patients should not take any anti-oxidants such as Vitamin C or E.

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• Fenretinide
1800 mg/m2 per day for seven consecutive days, in two divided doses of 900 mg/m2 12 hours apart, repeated every 3 weeks.

Locations

Country	Name	City	State
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the response rate, time to progression, median survival, and percent one-year survival	To determine the response rate, time to progression, median survival, and percent one-year survival.	one-year survival

External Links

•   UT MD Anderson Cancer Center Website