Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Larynx or Oropharynx Cancer - Full Text View

Sponsors and Collaborators:	Eastern Cooperative Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00014118

Purpose

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.

Condition	Intervention	Phase
Head and Neck Cancer	Drug: carboplatin Drug: paclitaxel Procedure: conventional surgery Procedure: radiation therapy	Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Carboplatin Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Organ preservation rate [ Designated as safety issue: No ]
Feasibility and toxicity [ Designated as safety issue: Yes ]
Utility of pre- and post-treatment organ function instruments [ Designated as safety issue: No ]
Disease-free survival and patterns of failure [ Designated as safety issue: No ]
Objective tumor response rate (complete and partial response) [ Designated as safety issue: No ]
Changes in quality of life [ Designated as safety issue: No ]
Correlation of the presence of human papilloma virus infection and p-glycoprotein with outcome [ Designated as safety issue: No ]

Study Start Date:

March 2001

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00014118

Show 47 Study Locations

Sponsors and Collaborators

Eastern Cooperative Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Anthony J. Cmelak, MD

Vanderbilt-Ingram Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications of Results:

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 12; [Epub ahead of print]

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.

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.

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.

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.

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.

Study ID Numbers:	CDR0000068468, ECOG-2399
Study First Received:	April 10, 2001
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00014118
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Otorhinolaryngologic Neoplasms
Otorhinolaryngologic Diseases
Squamous cell carcinoma
Laryngeal Neoplasms
Carboplatin
Carcinoma
Epidermoid carcinoma
Respiratory Tract Diseases

Paclitaxel
Head and Neck Neoplasms
Carcinoma, squamous cell
Laryngeal carcinoma
Neoplasms, Squamous Cell
Laryngeal Diseases
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Mitosis Modulators
Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009