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


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the response rate, time to progression, median survival, and percent one-year survival

Outcome Description:

To determine the response rate, time to progression, median survival, and percent one-year survival.

Outcome Time Frame:

one-year survival

Safety Issue:

Yes

Principal Investigator

Bonnie S. Glisson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

ID99-334

NCT ID:

NCT00006471

Start Date:

September 2000

Completion Date:

July 2004

Related Keywords:

  • Head and Neck Cancer
  • untreated metastatic squamous neck cancer with occult primary
  • recurrent metastatic squamous neck cancer with occult primary
  • metastatic squamous neck cancer with occult primary squamous cell carcinoma
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • recurrent squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the oropharynx
  • recurrent squamous cell carcinoma of the oropharynx
  • recurrent squamous cell carcinoma of the nasopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • recurrent squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the larynx
  • recurrent squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
  • recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage IV squamous cell carcinoma of the nasopharynx
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009