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Trial record 33 of 62 for:    dry mouth | NIH

Randomized Amifostine For SCCHN

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ClinicalTrials.gov Identifier: NCT00095927
Recruitment Status : Completed
First Posted : November 9, 2004
Last Update Posted : January 4, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
MedImmune LLC
AstraZeneca
Information provided by (Responsible Party):
Robert I. Haddad, MD, 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.

Condition or disease Intervention/treatment Phase
Chemotherapeutic Agent Toxicity Head and Neck Cancer Mucositis Radiation Toxicity Xerostomia Drug: Amifostine Drug: Carboplatin Drug: Paclitaxel Radiation: radiation Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II, Randomized Study of Concomitant Chemoradiation Using Weekly Carboplatinum/Paclitaxel With (Arm A) or Without (Arm B) Daily Subcutaneous Amifostine in Patients With Newly Diagnosed Locally Advanced Squamous Cell Cancer of the Head and Neck
Study Start Date : May 2003
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2008


Arm Intervention/treatment
Active Comparator: Arm A 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
Drug: Amifostine
Given subcutaneously
Other Name: Ethyo

Drug: Carboplatin
Given IV
Other Name: Paraplatin

Drug: Paclitaxel
Given IV
Other Names:
  • Taxol
  • Onxal

Radiation: radiation
Given once daily for 4 weeks and then twice daily for 2 weeks.

Experimental: Arm B No-Amifostine

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
Given IV
Other Name: Paraplatin

Drug: Paclitaxel
Given IV
Other Names:
  • Taxol
  • Onxal

Radiation: radiation
Given once daily for 4 weeks and then twice daily for 2 weeks.




Primary Outcome Measures :
  1. Rate of local/regional control (LRC) 1 year after beginning treatment [ Time Frame: One year after beginning of treatment ]
  2. Proportion of patients with grade 2 or 3 chronic xerostomia at 3, 6 months [ Time Frame: 3, 6 Months ]
  3. Proportion of patients with grade 3 and 4 mucositis as assessed by RTOG criteria once weekly during and after completion of radiotherapy [ Time Frame: End of Radiotherapy ]
  4. Median duration of dependence on percutaneous endoscopic gastrectomy (PEG) for adequate nutrition at 8, 12, 24, and 52 weeks after completion of study treatment [ Time Frame: 8,12, 24 and 52 weeks ]

Secondary Outcome Measures :
  1. Duration of grade 3 and 4 mucositis once weekly during treatment and at 8, 12, 24, and 52 weeks after completion of study treatment [ Time Frame: 8, 12, 24, and 52 weeks ]
  2. Proportion of patients with PEG dependency [ Time Frame: 3, 6, and 12 months after completion of study treatment ]
  3. Time to disease progression [ Time Frame: baseline to disease progression ]
    Kaplan and Meier

  4. Quality of life as assessed by Functional Assessment of Cancer Therapy for Head and Neck Cancer (FACT-H&N) Survey [ Time Frame: baseline, 8, 12, 24, and 52 weeks after completion of study treatment ]
  5. LRC and overall survival at 2 years after completion of study treatment [ Time Frame: 2 Years after completion of study treatment ]
  6. Swallowing function [ Time Frame: 2 years Post treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00095927


Locations
United States, Maine
Goodall Hospital
Sanford, Maine, United States, 04703
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Bethke Cancer Center at Emerson Hospital
Concord, Massachusetts, United States, 01742
Mass General/North Shore Cancer Center
Danvers, Massachusetts, United States, 01923
Saint Anne's Hospital - Fall River
Fall River, Massachusetts, United States, 02721
Lowell General Hospital
Lowell, Massachusetts, United States, 01854
United States, New Hampshire
Wentworth Douglass Hospital
Dover, New Hampshire, United States, 03820
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
MedImmune LLC
AstraZeneca
Investigators
Principal Investigator: Robert I. Haddad, MD Dana-Farber Cancer Institute

Publications of Results:
Responsible Party: Robert I. Haddad, MD, Haddad, Robert I.,M.D., Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00095927     History of Changes
Other Study ID Numbers: 03018
P30CA006516 ( U.S. NIH Grant/Contract )
First Posted: November 9, 2004    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Robert I. Haddad, MD, Dana-Farber Cancer Institute:
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
radiation toxicity
chemotherapeutic agent toxicity
mucositis
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

Additional relevant MeSH terms:
Xerostomia
Mouth Diseases
Head and Neck Neoplasms
Mucositis
Radiation Injuries
Neoplasms by Site
Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomatognathic Diseases
Salivary Gland Diseases
Wounds and Injuries
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Amifostine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs