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

NCT00014118 | Completed Phase 2

• 3 other identifiers: CDR0000068468U10CA021115ECOG-2399
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 47

Brief 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.

Conditions

Head and Neck Cancer

Keywords

stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the larynx

Outcome Measures

Primary Outcomes (7)

• Organ preservation rate

• Feasibility and toxicity

• Utility of pre- and post-treatment organ function instruments

• Disease-free survival and patterns of failure

• Objective tumor response rate (complete and partial response)

• Changes in quality of life

• Correlation of the presence of human papilloma virus infection and p-glycoprotein with outcome

Interventions

carboplatin DRUG

paclitaxel DRUG

conventional surgery PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (47)

Baptist Cancer Institute - Jacksonville

Jacksonville, Florida, 32207, United States

Location

Watson Clinic, LLC

Lakeland, Florida, 33804-5000, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Hematology and Oncology Associates

Chicago, Illinois, 60611, United States

Location

Mercy Hospital and Medical Center

Chicago, Illinois, 60616, United States

Location

Ingalls Cancer Care Center at Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States

Location

Midwest Center for Hematology/Oncology

Joliet, Illinois, 60432, United States

Location

Cancer Care and Hematology Specialists of Chicagoland - Niles

Niles, Illinois, 60714, United States

Location

Hematology Oncology Associates - Skokie

Skokie, Illinois, 60076, United States

Location

Hematology/Oncology of the North Shore at Gross Point Medical Center

Skokie, Illinois, 60076, United States

Location

Siouxland Hematology-Oncology Associates, LLP

Sioux City, Iowa, 51101, United States

Location

Mercy Medical Center - Sioux City

Sioux City, Iowa, 51104, United States

Location

St. Luke's Regional Medical Center

Sioux City, Iowa, 51104, United States

Location

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, 66720, United States

Location

Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, 67801, United States

Location

Cancer Center of Kansas, PA - El Dorado

El Dorado, Kansas, 67042, United States

Location

Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, 67068, United States

Location

Southwest Medical Center

Liberal, Kansas, 67901, United States

Location

Cancer Center of Kansas, PA - Newton

Newton, Kansas, 67114, United States

Location

Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, 67357, United States

Location

Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, 67124, United States

Location

Cancer Center of Kansas, PA - Salina

Salina, Kansas, 67042, United States

Location

Cancer Center of Kansas, PA - Wellington

Wellington, Kansas, 67152, United States

Location

Associates in Womens Health, PA - North Review

Wichita, Kansas, 67203, United States

Location

Cancer Center of Kansas, PA - Medical Arts Tower

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas, PA - Wichita

Wichita, Kansas, 67214, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214, United States

Location

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Wesley Medical Center

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas, PA - Winfield

Winfield, Kansas, 67156, United States

Location

Borgess Medical Center

Kalamazoo, Michigan, 49001, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007-3731, United States

Location

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

Location

Aultman Cancer Center at Aultman Hospital

Canton, Ohio, 44710-1799, United States

Location

MetroHealth Cancer Care Center at MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Guthrie Cancer Center at Guthrie Clinic Sayre

Sayre, Pennsylvania, 18840, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Mary Babb Randolph Cancer Center at West Virginia University Hospitals

Morgantown, West Virginia, 26506, United States

Location

Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, 54301-3526, United States

Location

Green Bay Oncology, Limited at St. Mary's Hospital

Green Bay, Wisconsin, 54303, United States

Location

St. Mary's Hospital Medical Center - Green Bay

Green Bay, Wisconsin, 54303, United States

Location

St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, 54307-3508, United States

Location

Bay Area Cancer Care Center at Bay Area Medical Center

Marinette, Wisconsin, 54143, United States

Location

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, 54449, United States

Location

Marshfield Clinic - Indianhead Center

Rice Lake, Wisconsin, 54868, United States

Location

Related Publications (6)

• 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(4):261-9. doi: 10.1093/jnci/djn011. Epub 2008 Feb 12.

  PMID: 18270337 RESULT

• 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 Eastern Cooperative Oncology Group Study E2399. J Clin Oncol. 2007 Sep 1;25(25):3971-7. doi: 10.1200/JCO.2007.10.8951.

  PMID: 17761982 RESULT

• 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 18): A-6000, 299s, 2007.

  RESULT

• 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.

  RESULT

• 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-5524, 2006.

  RESULT

• 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 American Society of Clinical Oncology 22: A-2005, 2003.

  RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Carboplatin; Paclitaxel; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Therapeutics

Study Officials

• Anthony J. Cmelak, MD

  Vanderbilt-Ingram Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2001
• First Posted: January 27, 2003
• Study Start: June 6, 2001
• Primary Completion: March 1, 2007
• Study Completion: May 1, 2009
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

US (47)