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Fenretinide in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
This study is ongoing, but not recruiting participants.
First Received: November 6, 2000   Last Updated: July 23, 2008   History of Changes
Sponsor: M.D. Anderson Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006471
  Purpose

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 Intervention Phase
Head and Neck Cancer
Drug: fenretinide
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Study of Fenretinide in Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 2000
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006471

Locations
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Bonnie S. Glisson, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068294, MDA-ID-99334, NCI-610
Study First Received: November 6, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00006471     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Anticarcinogenic Agents
Neoplasms by Histologic Type
Antineoplastic Agents
Physiological Effects of Drugs
Protective Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Therapeutic Uses
Neoplasms, Squamous Cell
Fenretinide
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 09, 2009