Randomized Amifostine For SCCHN

Phase 2

Completed

• Conditions: Head and Neck Cancer; Mucositis; Chemotherapeutic Agent Toxicity; Radiation Toxicity; Xerostomia
• Interventions: Drug: Amifostine; Drug: Carboplatin; Radiation: radiation; Drug: Paclitaxel

• Registration Number: NCT00095927
• Lead Sponsor: Dana-Farber Cancer Institute

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.

Study Timeline

• Study Start: 2003-05
• Study First Submitted QC: 2004-11-08
• Study First Submitted: 2004-11-09
• Study First Posted: 2004-11-09
• Primary Completion: 2007-06
• Study Completion: 2008-06
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-03
• Last Update Posted: 2017-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Not provided

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B No-Amifostine	radiation	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).
Arm A Amifostine	radiation	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
Arm A Amifostine	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
Arm A Amifostine	Carboplatin	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
Arm A Amifostine	Paclitaxel	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
Arm B No-Amifostine	Carboplatin	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).
Arm B No-Amifostine	Paclitaxel	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).

Primary Outcome Measures

Name	Time	Method
Rate of local/regional control (LRC) 1 year after beginning treatment	One year after beginning of treatment
Proportion of patients with grade 2 or 3 chronic xerostomia at 3, 6 months	3, 6 Months
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
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

Secondary Outcome Measures

Name	Time	Method
Swallowing function	2 years Post treatment
Proportion of patients with PEG dependency	3, 6, and 12 months after completion of study treatment
Time to disease progression	baseline to disease progression	Kaplan and Meier
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
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
LRC and overall survival at 2 years after completion of study treatment	2 Years after completion of study treatment

Trial Locations

Locations (9)

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

Lowell General Hospital; 🇺🇸 Lowell, 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

Wentworth Douglass Hospital; 🇺🇸 Dover, New Hampshire, United States