Randomized Amifostine For SCCHN

NCT ID: NCT00095927

Last Updated: 2017-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-05-31
• Study Completion Date: 2008-06-30

Brief Summary

This research study is studying a drug called Amifostine as a treatment for squamous cell carcinoma in the head and/or neck area.

Detailed Description

Amifostine is a drug that is used to treat moderate to severe xerostomia (dry mouth) for those who receive radiation therapy for head and neck cancer. It was approved by the FDA for use intravenously. This study plans to examine the effects of xerostomia when Amifostine is used subcutaneously (by injection). Amifostine has been seen to be effective when used to combat the effects of dry mouth, but also has some side effects which are listed later in this consent form.

The purpose of this study is to examine the effectiveness of twice a day radiation therapy given with chemotherapy consisting of carboplatin and paclitaxel (Taxo 1). This study will examine the effectiveness of adding Amifostine in the hopes of reducing the side effects of radiation.

Conditions

Chemotherapeutic Agent Toxicity; Head and Neck Cancer; Mucositis; Radiation Toxicity; Xerostomia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A Amifostine

Patients with newly diagnosed, locally advanced stage ill or IV SCCHN received;

• 4 weekly doses of carboplatin (area under the curve, 1.5) and paclitaxel (45 mg/m 2) concurrently with concomitant boost radiation consisting of 72 grays in 42 fractions over 6 weeks (every day for 18 days, twice a day for 12 days) (grading determined according to the TNM staging system).
• Subcutaneous daily amifostine at a dose of 500 mg

Group Type: ACTIVE_COMPARATOR

Amifostine

Intervention Type: DRUG

Given subcutaneously

Carboplatin

Intervention Type: DRUG

Given IV

Paclitaxel

Intervention Type: DRUG

Given IV

radiation

Intervention Type: RADIATION

Given once daily for 4 weeks and then twice daily for 2 weeks.

Arm B No-Amifostine

Patients with newly diagnosed, locally advanced stage ill or IV SCCHN

• 4 weekly doses of carboplatin (area under the curve, 1.5) and paclitaxel (45 mg/m 2) concurrently with concomitant boost radiation consisting of 72 grays in 42 fractions over 6 weeks (every day for 18 days, twice a day for 12 days) (grading determined according to the TNM staging system).

Group Type: EXPERIMENTAL

Carboplatin

Intervention Type: DRUG

Given IV

Paclitaxel

Intervention Type: DRUG

Given IV

radiation

Intervention Type: RADIATION

Given once daily for 4 weeks and then twice daily for 2 weeks.

Interventions

Amifostine

Given subcutaneously

Intervention Type: DRUG

Carboplatin

Given IV

Intervention Type: DRUG

Paclitaxel

Given IV

Intervention Type: DRUG

radiation

Given once daily for 4 weeks and then twice daily for 2 weeks.

Intervention Type: RADIATION

Other Intervention Names

Ethyo; Paraplatin; Taxol; Onxal

Eligibility Criteria

Inclusion Criteria

• Histologically or cytologically proven squamous cell carcinoma of the head and neck. Biopsy is preferred unless medically contraindicated.
• Primary tumor sites eligible: oral cavity, oropharynx, hypopharynx or larynx. Tumors of the nasal and paranasal cavities will also be included. Unknown primary SCC in the neck will also be eligible.
• Stage 2, 3 or 4 disease without evidence of distant metastases verified by chest X-Ray, abdominal ultrasound or CT (in case of liver function test abnormalities); bone scan in case of local symptoms.
• At least one uni- or bidimensionally measurable lesion at the start of all therapy (induction therapy ag well as chemoradiation).
• No previous head and neck radiotherapy and no previous curative surgery for SCCHN (other than biopsy) are allowed at time of study entry.
• Age ≥ 18 years.
• WHO performance status of 0 or 1 (section 13, Appendix I)
• No active alcohol addiction (as assessed by medical caregiver).
• Life expectancy ≥ 12 weeks.
• Signed informed consent prior to beginning protocol specific procedures.
• Adequate bone marrow, hepatic and renal functions as evidenced by the following:

• Hematology:

• neutrophil count ≥ 2.0 x 10 9/1.
• platelet count ≥ 100 x 10 9/1.
• hemoglobin ≥ 10 g/dl.
• Hepatic function:

• total bilinthin WNL.
• ASAT (SGOT) and ALAT (SGPT) ≤ 2.5 x 1JLN.
• alkaline phosphatase ≤ 5 x ULN.
• patients with ASAT or ALAT > 1.5 x ULN associated with alkaline phosphatase > 2.5
• x ULN are not eligible for the study.
• Renal function: the creatinine clearance ≥ 60 ml/min (actual or calculated by the Cockcroft-Gault method as follows:

• Weight(kg) x (140 - age)/K x serum creatinine
• serum creatinine in mg/dL

• K: 72 in man
• K: 85 in woman
• serum creatinine in µmon/L

• K: 0.814 in man
• K: 0.96 in woman
• Patients must be available for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centers
• Previous chemotherapy is permitted, provided that it is in induction form before starting radiation therapy and that it is being used to treat head and neck cancers.

Exclusion Criteria

• Pregnant or lactating women, or women of childbearing potential not using adequate contraception.
• Previous or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma of the skin or other cancer curatively treated by surgery and with no evidence of disease for at least 3 years.
• Symptomatic peripheral neuropathy ≥ grade 2 by NCIC-CTG criteria.
• Other serious illnesses or medical conditions including but not limited to:

• Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
• History of significant neurologic or psychiatric disorders including dementia or seizures.
• Active uncontrolled infection.
• Active peptic ulcer.
• Hypercalcemia.
• Chronic obstructive pulmonary disease requiring hospitalization during the year preceding study entry.
• Patients requiring intravenous alimentation.
• Patients who experienced a weight loss of more than 20% of their body weight in the 3 months preceding study entry (unless purposeful)
• Concurrent treatment with any other anticancer therapy.
• Participation in an investigational trial within 30 days of study entry.
• Previous treatment with any biologic therapy is not permitted.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

MedImmune LLC

INDUSTRY

Sponsor Role: collaborator

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Robert I. Haddad, MD

Haddad, Robert I.,M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert I. Haddad, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Goodall Hospital

Sanford, Maine, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Bethke Cancer Center at Emerson Hospital

Concord, Massachusetts, United States

Mass General/North Shore Cancer Center

Danvers, Massachusetts, United States

Saint Anne's Hospital - Fall River

Fall River, Massachusetts, United States

Lowell General Hospital

Lowell, Massachusetts, United States

Wentworth Douglass Hospital

Dover, New Hampshire, United States

Countries

United States

References

Haddad R, Sonis S, Posner M, Wirth L, Costello R, Braschayko P, Allen A, Mahadevan A, Flynn J, Burke E, Li Y, Tishler RB. Randomized phase 2 study of concomitant chemoradiotherapy using weekly carboplatin/paclitaxel with or without daily subcutaneous amifostine in patients with locally advanced head and neck cancer. Cancer. 2009 Oct 1;115(19):4514-23. doi: 10.1002/cncr.24525.

Reference Type: RESULT

PMID: 19634161 (View on PubMed)

Other Identifiers

P30CA006516

Identifier Type: NIH

Identifier Source: secondary_id

View Link

03018

Identifier Type: -

Identifier Source: org_study_id