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

Eastern Cooperative Oncology Group

Status and phase

Completed

Phase 2

Conditions

Head and Neck Cancer

Treatments

Drug: paclitaxel

Drug: carboplatin

Procedure: conventional surgery

Radiation: radiation therapy

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT00014118

ECOG-2399

CDR0000068468

U10CA021115 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

Determine the organ preservation rate in patients with stage III or IV squamous cell carcinoma of the larynx or oropharynx treated with paclitaxel and carboplatin followed by paclitaxel with concurrent radiotherapy.
Determine the feasibility and toxicity of this regimen in these patients.
Determine the utility of pre- and post-treatment organ function instruments on swallowing ability and voice quality in patients treated with this regimen.
Determine the disease-free survival and patterns of failure of patients treated with this regimen.
Determine the objective tumor response rate (complete and partial response) in these patients following treatment with 2 courses of induction therapy with paclitaxel and carboplatin.
Determine changes in quality of life of patients treated with this regimen.
Determine whether the presence of human papilloma virus infection and p-glycoprotein correlates with outcome in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to disease site (larynx vs oropharynx).

Patients receive induction therapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 30-60 minutes on days 1 and 22. Within 28 days after completion of induction therapy, patients with responding or stable disease receive paclitaxel IV over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 and radiotherapy once daily, 5 times weekly, for 7 weeks beginning on day 1.

Within 6-8 weeks after completion of therapy, patients who initially had bulky neck disease (N3) or who have residual palpable lymphadenopathy undergo surgical neck dissection. Patients with N1-N2 disease with complete response may also undergo neck dissection. Patients with initial complete response who recur at the primary site undergo surgical salvage.

Quality of life is assessed at baseline, after induction therapy, and at 3, 12, and 24 months after completion of all therapy.

Patients are followed at 6 weeks, 3 months, every 6-8 weeks for 1 year, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 5 years thereafter.

PROJECTED ACCRUAL: A total of 110 patients (55 per stratum) will be accrued for this study.

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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