Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

Randomized Amifostine For SCCHN

Lead Sponsor:

Dana-Farber Cancer Institute

Collaborating Sponsors:

National Cancer Institute (NCI)

MedImmune LLC

Conditions:

Chemotherapeutic Agent Toxicity

Head and Neck Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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....

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    May 1 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 1 2008

    Estimated Enrollment :

    58 Patients enrolled

    Trial Details

    Trial ID

    NCT00095927

    Start Date

    May 1 2003

    End Date

    June 1 2008

    Last Update

    January 4 2017

    Active Locations (9)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (9 locations)

    1

    Goodall Hospital

    Sanford, Maine, United States, 04703

    2

    Massachusetts General Hospital

    Boston, Massachusetts, United States, 02114

    3

    Dana-Farber Cancer Institute

    Boston, Massachusetts, United States, 02115

    4

    Beth Israel Deaconess Medical Center

    Boston, Massachusetts, United States, 02215