Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Eastern Cooperative Oncology Group

Anthony J. Cmelak

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00014118
Information obtained from ClinicalTrials.gov on December 14, 2011

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