Fenretinide in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
A Phase II Study of Fenretinide in Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck
6 other identifiers
interventional
11
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 head-and-neck-cancer
Started Sep 2000
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2000
CompletedFirst Submitted
Initial submission to the registry
November 6, 2000
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2004
CompletedNovember 1, 2018
October 1, 2018
3.8 years
November 6, 2000
October 30, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Fenretinide
EXPERIMENTALInterventions
1800 mg/m2 per day for seven consecutive days, in two divided doses of 900 mg/m2 12 hours apart, repeated every 3 weeks.
Eligibility Criteria
You may qualify if:
- Biopsy-proven recurrent squamous cell carcinoma of the head and neck
- 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.
- 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.
- Patients must have a life expectancy of at least 3 months
- Biopsy of the recurrent lesion(s) is encouraged but not mandatory for enrollment.
- Performance status grade 0-2.
- Serum creatinine \<= 1.5 mg/dL.
- Serum transaminases and bilirubin \<= 1.5 time normal.
- Age \>= 18 years.
- White blood cell count \>= 3,000; platelets \>= 100,000; hemoglobin \>= 9mg/dl.
- Signed informed consent.
- 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.
- It is recommended that male patients with female partners of childbearing potential use barrier contraception while on fenretinide.
You may not qualify if:
- 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.
- Grade 2 or greater peripheral neuropathy
- Concurrent treatment with cytotoxic chemotherapy or radiation
- Serious infection or other intercurrent illness requiring immediate therapy.
- Inability to take oral medications, or other medical or social factors interfering with compliance.
- Patients on high dose synthetic or natural Vitamin A derivatives (\>= 10,000 per day).
- Patients should not take any anti-oxidants such as Vitamin C or E.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Bonnie S. Glisson, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2000
First Posted
January 27, 2003
Study Start
September 1, 2000
Primary Completion
July 1, 2004
Study Completion
July 1, 2004
Last Updated
November 1, 2018
Record last verified: 2018-10