Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Recurrent Head and Neck Cancer - Full Text View

Sponsor:	University of Pennsylvania
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003777

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. Drugs such as amifostine may prevent the side effects of radiation therapy. Combining more than one drug and combining radiation therapy and surgery with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining surgery, radiation therapy, and combination chemotherapy in treating patients who have recurrent head and neck cancer that has been treated previously with radiation therapy.

Condition	Intervention	Phase
Head and Neck Cancer	Drug: amifostine trihydrate Drug: cisplatin Drug: fluorouracil Procedure: surgical procedure Radiation: radiation therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Pilot Study of Combined Modality Therapy for Recurrent Head and Neck Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer Surgery

Drug Information available for: Fluorouracil Cisplatin Amifostine

U.S. FDA Resources

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

Estimated Enrollment:	35
Study Start Date:	December 1998

Detailed Description:

OBJECTIVES:

Determine the effectiveness and toxic effects of intensive salvage therapy and radiotherapy in previously irradiated patients with recurrent head and neck cancer.
Determine the feasibility and effectiveness of amifostine at limiting or minimizing side effects of repeat irradiation in these patients.

OUTLINE: Patients undergo surgical resection of gross disease (if not already done) followed by 4-6 weeks of rest. Patients receive radiotherapy over 5 consecutive days on weeks 1, 2, 4, and 5. Intravenous cisplatin is administered on days 1-3 and 29-31. Intravenous amifostine is administered 15-30 minutes prior to radiotherapy and cisplatin therapy. Patients receive fluorouracil IV continuously on days 1-4 and 29-32.

Patients are followed every month for 1 year, every 2 months for 1 year, every 3 months for 1 year, every 4 months for 1 year, then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 35 patients 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 recurrent or new primary squamous cell carcinoma of the head and neck occurring in a previously irradiated field
Pathologic stage of recurrence must be rT3-4 and/or rN2-3
The following sites are eligible:
- Oral cavity, oropharynx, or hypopharynx: Any rT2-4 and/or clinical rN+
- Larynx: Any rT4, rT3 with perineural invasion, or any rT with clinical rN+
- Any site: Positive margin(s), at least 2 nodes or ECS
No primary tumor of the nasopharynx
Must be eligible for or have undergone complete resection which leaves behind no gross residual disease
Must have prior head and neck irradiation of 45-75 Gy
Lifetime spinal cord radiotherapy dose no greater than 50 Gy
No ongoing RTOG late morbidity of grade 3 or greater (unless correctable by surgery)
No active acute radiation mucositis from previous radiotherapy

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

Karnofsky 70-100%

Life expectancy:

Not specified

Hematopoietic:

WBC at least 4,000/mm^3
Hemoglobin at least 9 g/dL (transfusion allowed)
Platelet count at least 100,000/mm^3

Hepatic:

SGOT or SGPT no greater than 3 times upper limit of normal
Bilirubin no greater than 2 mg/dL

Renal:

Creatinine no greater than 1.5 mg/dL

Cardiovascular:

No myocardial infarction, unstable angina, coronary heart failure, or uncontrolled arrhythmias within past 6 months
No severe cerebrovascular disease or hypotension not caused by antihypertensive medication

Other:

Not pregnant
Fertile patients must use effective contraception
No allergy to cisplatin, fluorouracil, or amifostine
No uncontrolled insulin-dependent diabetes mellitus or other medical condition interfering with wound healing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

No prior chemotherapy for tumor recurrence (except adjuvant chemotherapy)

Endocrine therapy:

Not specified

Radiotherapy:

See Disease Characteristics
At least 6 months since prior radiotherapy
Prior radiotherapy treatment records must be available

Surgery:

No prior salvage surgery consisting of partial laryngectomy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003777

Locations

United States, Pennsylvania
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104-4283

Sponsors and Collaborators

University of Pennsylvania

Investigators

Study Chair:

Mitchell Machtay, MD

Abramson Cancer Center of the University of Pennsylvania

More Information

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000066906, UPCC-6398, ALZA-98-023-ii, NCI-V99-1518
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00003777 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage III lip and oral cavity cancer
stage IV lip and oral cavity cancer
recurrent lip and oral cavity cancer
stage III hypopharyngeal cancer
stage IV hypopharyngeal cancer
recurrent hypopharyngeal cancer
stage III laryngeal cancer
stage IV laryngeal cancer

recurrent laryngeal cancer
stage III paranasal sinus and nasal cavity cancer
stage IV paranasal sinus and nasal cavity cancer
recurrent paranasal sinus and nasal cavity cancer
stage III oropharyngeal cancer
stage IV oropharyngeal cancer
recurrent oropharyngeal cancer

Additional relevant MeSH terms:

Antimetabolites
Radiation-Protective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Amifostine
Antineoplastic Agents
Physiological Effects of Drugs
Immunosuppressive Agents

Protective Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Cisplatin
Radiation-Sensitizing Agents
Head and Neck Neoplasms
Fluorouracil
Therapeutic Uses

ClinicalTrials.gov processed this record on February 08, 2010