Randomized Amifostine For SCCHN

Head and Neck Cancer Clinical Trial

Official title:

Phase II, Randomized Study of Concomitant Chemoradiation Using Weekly Carboplatinum/Paclitaxel With (Arm A) or Without (Arm B) Daily Subcutaneous Amifostine in Patients With Newly Diagnosed Locally Advanced Squamous Cell Cancer of the Head and Neck

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00095927
• Other study ID #: 03018
• Secondary ID: P30CA006516
• Status: Completed
• Phase: Phase 2
• First received: November 9, 2004
• Last updated: January 3, 2017
• Start date: May 2003
• Est. completion date: June 2008

Study information

• Verified date: January 2017
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: June 2008
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chemotherapeutic Agent Toxicity
• Head and Neck Cancer
• Head and Neck Neoplasms
• Mucositis
• Radiation Injuries
• Radiation Toxicity
• Xerostomia

Intervention

Drug:
• Amifostine
Given subcutaneously
• Carboplatin
Given IV
• Paclitaxel
Given IV

Radiation:
• radiation
Given once daily for 4 weeks and then twice daily for 2 weeks.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Bethke Cancer Center at Emerson Hospital	Concord	Massachusetts
United States	Mass General/North Shore Cancer Center	Danvers	Massachusetts
United States	Wentworth Douglass Hospital	Dover	New Hampshire
United States	Saint Anne's Hospital - Fall River	Fall River	Massachusetts
United States	Lowell General Hospital	Lowell	Massachusetts
United States	Goodall Hospital	Sanford	Maine

Sponsors (4)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	AstraZeneca, MedImmune LLC, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 amif — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of local/regional control (LRC) 1 year after beginning treatment		One year after beginning of treatment	No
Primary	Proportion of patients with grade 2 or 3 chronic xerostomia at 3, 6 months		3, 6 Months	No
Primary	Proportion of patients with grade 3 and 4 mucositis as assessed by RTOG criteria once weekly during and after completion of radiotherapy		End of Radiotherapy	No
Primary	Median duration of dependence on percutaneous endoscopic gastrectomy (PEG) for adequate nutrition at 8, 12, 24, and 52 weeks after completion of study treatment		8,12, 24 and 52 weeks	No
Secondary	Duration of grade 3 and 4 mucositis once weekly during treatment and at 8, 12, 24, and 52 weeks after completion of study treatment		8, 12, 24, and 52 weeks	No
Secondary	Proportion of patients with PEG dependency		3, 6, and 12 months after completion of study treatment	No
Secondary	Time to disease progression	Kaplan and Meier	baseline to disease progression	No
Secondary	Quality of life as assessed by Functional Assessment of Cancer Therapy for Head and Neck Cancer (FACT-H&N) Survey		baseline, 8, 12, 24, and 52 weeks after completion of study treatment	No
Secondary	LRC and overall survival at 2 years after completion of study treatment		2 Years after completion of study treatment	No
Secondary	Swallowing function		2 years Post treatment	No