Phase 2
N=21
EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER.(GCC 0202)
Head and Neck Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00270790 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcome: Primary: Participants With Mucositis and Hematological Toxicities With the Addition of Radioprotector Amifostine — 16 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Amifostine (Drug); Carboplatin (Drug); Taxol (Drug); Radiotherapy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mohan Suntharalingam
- Primary completion
- Dec 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With Mucositis and Hematological Toxicities With the Addition of Radioprotector Amifostine |
16 | — |
| SECONDARY Response Rates Based on the Study Regimen |
16 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00270790). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.