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Randomized Amifostine For SCCHN

Primary Purpose

Chemotherapeutic Agent Toxicity, Head and Neck Cancer, Mucositis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Amifostine
Carboplatin
Paclitaxel
radiation
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chemotherapeutic Agent Toxicity focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Goodall Hospital
  • Massachusetts General Hospital
  • Dana-Farber Cancer Institute
  • Beth Israel Deaconess Medical Center
  • Bethke Cancer Center at Emerson Hospital
  • Mass General/North Shore Cancer Center
  • Saint Anne's Hospital - Fall River
  • Lowell General Hospital
  • Wentworth Douglass Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A Amifostine

Arm B No-Amifostine

Arm Description

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

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).

Outcomes

Primary Outcome Measures

Rate of local/regional control (LRC) 1 year after beginning treatment
Proportion of patients with grade 2 or 3 chronic xerostomia at 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
Median duration of dependence on percutaneous endoscopic gastrectomy (PEG) for adequate nutrition at 8, 12, 24, and 52 weeks after completion of study treatment

Secondary Outcome Measures

Duration of grade 3 and 4 mucositis once weekly during treatment and at 8, 12, 24, and 52 weeks after completion of study treatment
Proportion of patients with PEG dependency
Time to disease progression
Kaplan and Meier
Quality of life as assessed by Functional Assessment of Cancer Therapy for Head and Neck Cancer (FACT-H&N) Survey
LRC and overall survival at 2 years after completion of study treatment
Swallowing function

Full Information

First Posted
November 9, 2004
Last Updated
January 3, 2017
Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI), MedImmune LLC, AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00095927
Brief Title
Randomized Amifostine For SCCHN
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 Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI), MedImmune LLC, AstraZeneca

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A Amifostine
Arm Type
Active Comparator
Arm Description
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
Arm Title
Arm B No-Amifostine
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Amifostine
Other Intervention Name(s)
Ethyo
Intervention Description
Given subcutaneously
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Paraplatin
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol, Onxal
Intervention Description
Given IV
Intervention Type
Radiation
Intervention Name(s)
radiation
Intervention Description
Given once daily for 4 weeks and then twice daily for 2 weeks.
Primary Outcome Measure Information:
Title
Rate of local/regional control (LRC) 1 year after beginning treatment
Time Frame
One year after beginning of treatment
Title
Proportion of patients with grade 2 or 3 chronic xerostomia at 3, 6 months
Time Frame
3, 6 Months
Title
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
Title
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 Measure Information:
Title
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
Title
Proportion of patients with PEG dependency
Time Frame
3, 6, and 12 months after completion of study treatment
Title
Time to disease progression
Description
Kaplan and Meier
Time Frame
baseline to disease progression
Title
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
Title
LRC and overall survival at 2 years after completion of study treatment
Time Frame
2 Years after completion of study treatment
Title
Swallowing function
Time Frame
2 years Post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert I. Haddad, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Goodall Hospital
City
Sanford
State/Province
Maine
ZIP/Postal Code
04703
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Bethke Cancer Center at Emerson Hospital
City
Concord
State/Province
Massachusetts
ZIP/Postal Code
01742
Country
United States
Facility Name
Mass General/North Shore Cancer Center
City
Danvers
State/Province
Massachusetts
ZIP/Postal Code
01923
Country
United States
Facility Name
Saint Anne's Hospital - Fall River
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02721
Country
United States
Facility Name
Lowell General Hospital
City
Lowell
State/Province
Massachusetts
ZIP/Postal Code
01854
Country
United States
Facility Name
Wentworth Douglass Hospital
City
Dover
State/Province
New Hampshire
ZIP/Postal Code
03820
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19634161
Citation
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.
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Randomized Amifostine For SCCHN

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