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

Head and Neck Cancer Clinical Trial

Official title:

A Phase II Trial OF Chemoradiation For Organ Preservation In Resectable Stage III or IV Squamous Cell Carcinomas Of The Larynx Or Oropharynx

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00014118
• Other study ID #: CDR0000068468
• Secondary ID: U10CA021115ECOG-
• Status: Completed
• Phase: Phase 2
• Start date: June 6, 2001
• Est. completion date: May 2009

Study information

• Verified date: June 2023
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: May 2009
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• carboplatin

• paclitaxel

Procedure:
• conventional surgery

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	Aultman Cancer Center at Aultman Hospital	Canton	Ohio
United States	Cancer Center of Kansas, PA - Chanute	Chanute	Kansas
United States	Hematology and Oncology Associates	Chicago	Illinois
United States	Mercy Hospital and Medical Center	Chicago	Illinois
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois
United States	MetroHealth Cancer Care Center at MetroHealth Medical Center	Cleveland	Ohio
United States	Cancer Center of Kansas, PA - Dodge City	Dodge City	Kansas
United States	Cancer Center of Kansas, PA - El Dorado	El Dorado	Kansas
United States	Green Bay Oncology, Limited at St. Mary's Hospital	Green Bay	Wisconsin
United States	Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin
United States	St. Mary's Hospital Medical Center - Green Bay	Green Bay	Wisconsin
United States	St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin
United States	Ingalls Cancer Care Center at Ingalls Memorial Hospital	Harvey	Illinois
United States	Baptist Cancer Institute - Jacksonville	Jacksonville	Florida
United States	Midwest Center for Hematology/Oncology	Joliet	Illinois
United States	Borgess Medical Center	Kalamazoo	Michigan
United States	Bronson Methodist Hospital	Kalamazoo	Michigan
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Cancer Center of Kansas, PA - Kingman	Kingman	Kansas
United States	Watson Clinic, LLC	Lakeland	Florida
United States	Southwest Medical Center	Liberal	Kansas
United States	Bay Area Cancer Care Center at Bay Area Medical Center	Marinette	Wisconsin
United States	Marshfield Clinic - Marshfield Center	Marshfield	Wisconsin
United States	Mary Babb Randolph Cancer Center at West Virginia University Hospitals	Morgantown	West Virginia
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Cancer Center of Kansas, PA - Newton	Newton	Kansas
United States	Cancer Care and Hematology Specialists of Chicagoland - Niles	Niles	Illinois
United States	Cancer Center of Kansas, PA - Parsons	Parsons	Kansas
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania
United States	Cancer Center of Kansas, PA - Pratt	Pratt	Kansas
United States	Marshfield Clinic - Indianhead Center	Rice Lake	Wisconsin
United States	Cancer Center of Kansas, PA - Salina	Salina	Kansas
United States	Guthrie Cancer Center at Guthrie Clinic Sayre	Sayre	Pennsylvania
United States	Mercy Medical Center - Sioux City	Sioux City	Iowa
United States	Siouxland Hematology-Oncology Associates, LLP	Sioux City	Iowa
United States	St. Luke's Regional Medical Center	Sioux City	Iowa
United States	Hematology Oncology Associates - Skokie	Skokie	Illinois
United States	Hematology/Oncology of the North Shore at Gross Point Medical Center	Skokie	Illinois
United States	Cancer Center of Kansas, PA - Wellington	Wellington	Kansas
United States	Associates in Womens Health, PA - North Review	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Medical Arts Tower	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Wichita	Wichita	Kansas
United States	CCOP - Wichita	Wichita	Kansas
United States	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas
United States	Wesley Medical Center	Wichita	Kansas
United States	Cancer Center of Kansas, PA - Winfield	Winfield	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Eastern Cooperative Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (6)

Cmelak AJ, Li S, Goldwasser MA, Murphy B, Cannon M, Pinto H, Rosenthal DI, Gillison M, Forastiere AA. Phase II trial of chemoradiation for organ preservation in resectable stage III or IV squamous cell carcinomas of the larynx or oropharynx: results of Ea — View Citation

Cmelak AJ, Li S, Murphy B, et al.: Locally advanced resectable larynx (L) or oropharynx (OP) cancer: updated results of organ preservation trial ECOG 2399. [Abstract] J Clin Oncol 24 (Suppl 18): A-5527, 286s, 2006.

Fakhry C, Westra W, Li S, et al.: Prognostic significance of human papillomavirus (HPV) tumor status for patients with head and neck squamous cell carcinoma (HNSCC) in a prospective, multi-center phase II clinical trial. [Abstract] J Clin Oncol 25 (Suppl

Fakhry C, Westra WH, Li S, Cmelak A, Ridge JA, Pinto H, Forastiere A, Gillison ML. Improved survival of patients with human papillomavirus-positive head and neck squamous cell carcinoma in a prospective clinical trial. J Natl Cancer Inst. 2008 Feb 20;100( — View Citation

Murphy BA, Smith K, Cmelak A, et al.: Swallowing function for patients treated on E2399: a phase II trial of function preservation with induction paclitaxel/carboplatin followed by radiation plus weekly paclitaxel. [Abstract] J Clin Oncol 24 (Suppl 18): A

Murphy BA, Smith K, Dowling E, et al.: Baseline swallowing function for patients treated on E2399: a phase II trial of function preservation with induction paclitaxel/carboplatin followed by radiation plus weekly paclitaxel. [Abstract] Proceedings of the

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Organ preservation rate
Primary	Feasibility and toxicity
Primary	Utility of pre- and post-treatment organ function instruments
Primary	Disease-free survival and patterns of failure
Primary	Objective tumor response rate (complete and partial response)
Primary	Changes in quality of life
Primary	Correlation of the presence of human papilloma virus infection and p-glycoprotein with outcome