Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Larynx or Oropharynx Cancer

• Status: Completed
• Trial end date: 2009-05-01
• 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 II trial to study the effectiveness of combination chemotherapy followed by radiation therapy and chemotherapy in treating patients who have stage III or stage IV cancer of the larynx or stage III or stage IV cancer of the oropharynx.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eastern Cooperative Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carboplatin; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed stage III or IV (T2-T4) squamous cell carcinoma of the larynx or oropharynx

• No recurrent disease

• No evidence of distant metastasis

• Resectable disease, defined as follows:

• High probability of attaining clear surgical margins (for disease of the base of tongue, tonsil, soft palate, or pharyngeal wall)

• No extension to root of tongue (for disease of the base of tongue)

• No extension into pterygoid by radiograph (for disease of the tonsil, soft palate, or pharyngeal wall)

• No primary tumor or nodal metastases fixed to the carotid artery or cervical spine (for disease of the base of tongue, tonsil, soft palate, or pharyngeal wall)

• No trismus (for disease of the tonsil, soft palate, or pharyngeal wall)

• No involvement of the trachea greater than 1 cm or any involvement of the esophagus (for disease of the subglottis)

• For disease of the supraglottis, glottis, or subglottis:

• No base of the tongue invasion greater than 2 cm

• No tumor extension through cartilage to involve strap muscles of the neck

• No tumor fixation to prevertebral fascia

• No involvement of the carotid artery

• No fixed nodal disease with involvement of the deep neck

• Extension into pyriform sinus or lateral pharyngeal wall allowed if no extension into posterior pharynx

• Measurable disease

• - Lesions accurately measured in at least one dimension as > 20 mm (2.0 cm) with conventional techniques or as > 10 mm (1.0 cm) with spiral CT scan

• Cytologic or histologic evidence of neoplasm is needed for measurable disease restricted to a solitary lesion

• No other concurrent head and neck neoplasms

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic

• Not specified

Renal

• Creatinine less than 3.0 mg/dL

• Calcium normal

Cardiovascular

• No significant cardiac disease

• No uncontrolled hypertension

• No unstable angina

• No congestive heart failure

• No myocardial infarction within the past year

• No serious cardiac arrhythmias requiring medication

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for at least 3 months after study completion

• No significant detectable infection

• No history of allergy to drugs containing Cremophor EL

• No history of allergy to mammalian cell-derived products (epoetin alfa) or human albumin

• No other malignancy within the past 3 years except basal or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy

• No concurrent amifostine

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy above the clavicles

Surgery

• No prior surgery to the primary tumor except biopsy or debulking

Other

• No concurrent experimental mucosal protectants