Randomized Amifostine For SCCHN

NCT00095927 | Completed Phase 2 DMC

• 2 other identifiers: 03018P30CA006516
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 9

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.

Conditions

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

Keywords

radiation toxicity; chemotherapeutic agent toxicity; mucositis; xerostomia; stage II squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the lip and oral cavity; stage II squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx; stage II squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the hypopharynx; stage II squamous cell carcinoma of the larynx; stage III squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the larynx; stage II squamous cell carcinoma of the paranasal sinus and nasal cavity; stage III squamous cell carcinoma of the paranasal sinus and nasal cavity; stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity; untreated metastatic squamous neck cancer with occult primary; metastatic squamous neck cancer with occult primary squamous cell carcinoma

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• 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

• Proportion of patients with PEG dependency

  3, 6, and 12 months after completion of study treatment

• Time to disease progression

  baseline to disease progression

• 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

• LRC and overall survival at 2 years after completion of study treatment

  2 Years after completion of study treatment

Study Arms (2)

Arm A Amifostine

ACTIVE COMPARATOR

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

Drug: Amifostine; Drug: Carboplatin; Drug: Paclitaxel; Radiation: radiation

Arm B No-Amifostine

EXPERIMENTAL

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).

Drug: Carboplatin; Drug: Paclitaxel; Radiation: radiation

Interventions

Amifostine DRUG

Given subcutaneously

Also known as: Ethyo

Arm A Amifostine

Carboplatin DRUG

Given IV

Also known as: Paraplatin

Arm A Amifostine; Arm B No-Amifostine

Paclitaxel DRUG

Given IV

Also known as: Taxol, Onxal

Arm A Amifostine; Arm B No-Amifostine

radiation RADIATION

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

Arm A Amifostine; Arm B No-Amifostine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• National Cancer Institute (NCI): collaborator
• MedImmune LLC: collaborator
• AstraZeneca: collaborator

Study Sites (9)

Goodall Hospital

Sanford, Maine, 04703, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Bethke Cancer Center at Emerson Hospital

Concord, Massachusetts, 01742, United States

Location

Mass General/North Shore Cancer Center

Danvers, Massachusetts, 01923, United States

Location

Saint Anne's Hospital - Fall River

Fall River, Massachusetts, 02721, United States

Location

Lowell General Hospital

Lowell, Massachusetts, 01854, United States

Location

Wentworth Douglass Hospital

Dover, New Hampshire, 03820, United States

Location

Related 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 amifostine in patients with locally advanced head and neck cancer. Cancer. 2009 Oct 1;115(19):4514-23. doi: 10.1002/cncr.24525.

  PMID: 19634161 RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms; Mucositis; Radiation Injuries; Xerostomia; Squamous Cell Carcinoma of Head and Neck

Interventions

Amifostine; Carboplatin; Paclitaxel; Radiation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases; Wounds and Injuries; Salivary Gland Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Organothiophosphates; Organophosphates; Organophosphorus Compounds; Organic Chemicals; Organothiophosphorus Compounds; Sulfur Compounds; Coordination Complexes; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Physical Phenomena

Study Officials

• Robert I. Haddad, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Haddad, Robert I.,M.D.

Study Record Dates

• First Submitted: November 9, 2004
• First Posted: November 9, 2004
• Study Start: May 1, 2003
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2008
• Last Updated: January 4, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)