Overview

Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced and/or Recurrent Head and Neck Cancer

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have advanced and/or recurrent head and neck cancer.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Cancer Institute (NCI)
Treatments:
Albumin-Bound Paclitaxel
Fluorouracil
Gemcitabine
Paclitaxel
Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically proven head and neck cancer
requiring regional radiotherapy Locoregional, recurrent disease after primary therapy with
surgery, radiation, or both OR Stage IV, no prior therapy, and not amenable to conventional
therapy with curative intent Metastatic disease allowed if predominant site and associated
symptoms require local treatment in the head and neck region

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not
specified Hematopoietic: WBC greater than 3,000/mm3 Absolute neutrophil count greater than
1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 1.5
mg/dL Transaminases no greater than 2.5 times upper limit of normal Renal: Creatinine no
greater than 2.0 mg/dL Other: Not pregnant or nursing Fertile patients must use effective
contraception No significant infection No other severe medical illness

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Recovered from any
prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease
Characteristics Recovered from any prior radiotherapy Surgery: See Disease Characteristics
Recovered from any prior surgery