Fenretinide in Treating Patients With Recurrent or Metastatic Head and Neck Cancer (NCT00006471) | Clinical Trial Compass
CompletedPhase 2
Fenretinide in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
United States11 participantsStarted 2000-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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
What they're measuring
1
To determine the response rate, time to progression, median survival, and percent one-year survival