Combination Chemotherapy in Treating Patients With Advanced Head and Neck Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00002888
• Date of registration: 01/11/1999
• Primary sponsor: Eastern Cooperative Oncology Group
• Public title: Combination Chemotherapy in Treating Patients With Advanced Head and Neck Cancer
• Scientific title: A RANDOMIZED PHASE III EVALUATION OF PACLITAXEL + G-CSF + CISPLATIN VERSUS CISPLATIN + 5-FU IN ADVANCED HEAD AND NECK CANCER
• Date of first enrolment: March 1997
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00002888
• Study type: Interventional
• Study design: Allocation: Randomized, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Maha Hadi A. Hussain, MD
• Affiliation: Barbara Ann Karmanos Cancer Institute

• Name: Arlene A. Forastiere, MD
• Affiliation: Sidney Kimmel Comprehensive Cancer Center

Key inclusion & exclusion criteria

DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the head and
neck considered incurable by surgery or radiotherapy Newly diagnosed extensive
locoregional disease or distant metastases Locoregionally recurrent or persistent disease,
or distant metastases occurring after initial surgery or radiotherapy No nasopharyngeal
carcinoma No history of brain metastases Measurable or evaluable disease Documented
progressive disease or biopsy-proven residual carcinoma required if sole measurable site
previously irradiated

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0 or 1 Hematopoietic:
ANC at least 1,500/mm3 Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic:
Bilirubin less than 1.5 mg/dL AST/ALT no greater than twice normal Alkaline phosphatase no
greater than twice normal Renal: Creatinine no greater than 1.2 mg/dL OR Creatinine
clearance at least 50 mL/min Calcium normal No history of hypercalcemia Cardiovascular: No
congestive heart failure No serious arrhythmia requiring medication No myocardial
infarction within 6 months No medications known to alter cardiac conduction (i.e.,
lanoxin, beta or calcium channel blockers) Other: No significant detectable or occult
infection Complete evaluation required if elevated WBC (12,000 or greater) or fever (101.6
F or higher) No hypersensitivity to E. coli-derived proteins No allergy to drugs utilizing
Cremophor No other malignancy within 3 years except curatively treated nonmelanomatous
skin cancer or carcinoma in situ of the cervix Not pregnant Negative pregnancy test
Fertile patients must use effective contraception Must complete quality of life and pain
assessments at required intervals

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy for recurrent disease At least 12 months since induction or neoadjuvant
chemotherapy with paclitaxel or fluorouracil (6 months since cisplatin) Endocrine therapy:
Not specified Radiotherapy: See Disease Characteristics Surgery: Recovered from major
surgery



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Head and Neck Cancer

Intervention(s)

Drug: cisplatin

Drug: fluorouracil

Drug: paclitaxel

Secondary ID(s)

CDR0000065210

E-1395

SWOG-E1395

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)

Southwest Oncology Group