EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER.(GCC 0202)

NCT00270790 | Completed Phase 2 Results DMC

• 1 other identifier: HP-00021746
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose of this study: There is some evidence that the best treatment for head and neck cancer involves a combination of radiation therapy and chemotherapy. Radiation therapy is a form of cancer treatment using high energy x-rays. Chemotherapy is a form of cancer treatment that uses special medications. This study uses two chemotherapy drugs (Taxol and Carboplatin), which are FDA approved for treating head and neck cancers. This treatment combination has been associated with difficulty, pain, or a burning sensation upon swallowing (called esophagitis), and decrease in blood cells (cells in the blood which fight against infection). The purpose of this study is to investigate whether the addition of another drug, Amifostine, can reduce the side effects of current combination treatment (radiation and chemotherapy which is standard of care). The addition of Amifostine is the investigational part of the study. The research study is also looking at the side effects of Amifostine and cancer's growth response to this combination treatment.

Conditions

Head and Neck Cancer

Keywords

Head and Neck cancer

Outcome Measures

Primary Outcomes (1)

• Participants With Mucositis and Hematological Toxicities With the Addition of Radioprotector Amifostine

  Blood work (CMP was collected and evaluated for neutropenia, leukopenia and anemia) is taken prior to chemotherapy administration. The toxicity levels were measured using Common Terminology Criteria for Adverse Events (CTCAE 3.0) and monitored based on the dose of Amifostine given.

  3 years

Secondary Outcomes (1)

• Response Rates Based on the Study Regimen

  3 years

Study Arms (1)

AMIFOSTINE +CARBOPLATIN, TAXOL +RT

EXPERIMENTAL

EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER.

Drug: Amifostine; Drug: Carboplatin; Drug: Taxol; Device: Radiotherapy

Interventions

Amifostine DRUG

Amifostine will be given at dose of 500 mg IV within one hour before radiation

AMIFOSTINE +CARBOPLATIN, TAXOL +RT

Carboplatin DRUG

Carboplatin for 100 mg/m2 and will be administered after the taxol infusion

AMIFOSTINE +CARBOPLATIN, TAXOL +RT

Taxol DRUG

Taxol will be given at a dose of 40 mg/m2 as a 3 hour infusion dose

AMIFOSTINE +CARBOPLATIN, TAXOL +RT

Radiotherapy DEVICE

Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy

AMIFOSTINE +CARBOPLATIN, TAXOL +RT

Eligibility Criteria

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

You may qualify if:

• Histologically proved locally advanced squamous cell carcinoma of the head and neck of all primary sites. The following TNM stages by sites will be eligible.
• Oral cavity, Pharynx, Larynx, Nasopharynx, paranasal sinuses: T4 N0-3, A,B,C T3 N1-3 A,B,C any T, N3 A,B,C Unknown primary: Tx, N3 A,B,C Note: Only clearly unresectable T4 N0 lesions are eligible for study provided the reasons for unresectability are due to extensive anatomic involvement and are outlined by the surgeon.
• Karnofsky performance status of 70% or better at screen and on first day of treatment.
• Patients with loco-regional recurrences from any site with no prior radiation therapy and not amenable for salvage surgery are eligible for study.
• No evidence of distant metastatic disease.
• No previous radiation therapy
• No previous chemotherapy.
• Adequate renal \& bone marrow function determined by the following laboratory parameters.
• WBC 3500/ul or higher Platelet count 100.000/ul or higher Hemoglobin 9.0 g/dl or higher BUN 25 mg/dl or less, and Screatinine 2.0 mg/dl or less Total bilirubin less than 2.0 mg/dl, AST/ALT less than 3 times the ULN Creatinine Clearance 50 cc/min or higher
• Evidence of measurable disease.
• No evidence of concomitant malignancy except for non-melanomatous skin cancer (controlled or controllable) or carcinoma in situ of the cervix.
• Signed informed consent.
• No concomitant life threatening or uncontrolled serious medical illness such as end stage congestive heart failure cardiac arrythmia, liver disease and organic brain syndrome.
• Age 18 years or older.

You may not qualify if:

• Preexisting clinically significant neuropathy.
• Patients currently taking antiarrhythmic medications are excluded.
• History of poorly-controlled hypertension, angina, arrhythmias, or a history within the past 6 months of myocardial infarction or acute congestive heart failure.
• Requirement for concurrent use of pilocarpine.
• Treatment with any investigational drugs within 4 weeks of study entry.
• Pregnant or lactating females or females of child bearing potential not employing adequate contraception.

Sponsors & Collaborators

• Mohan Suntharalingam: lead
• MedImmune LLC: collaborator

Study Sites (1)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Amifostine; Carboplatin; Paclitaxel; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

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; Therapeutics

Results Point of Contact

• Title: Mohan Suntharalingam
• Organization: University of Maryland School of Medicine

msuntha@umm.edu

410-328-2328

Study Officials

• Mohan Suntharalingam, MD

  University of Maryland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 23, 2005
• First Posted: December 28, 2005
• Study Start: May 1, 2002
• Primary Completion: December 1, 2005
• Study Completion: February 1, 2009
• Last Updated: February 1, 2017
• Results First Posted: August 8, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)