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S0217, Adjuvant Cisplatin and Docetaxel After Complete Resection Stage III or IV Head and Neck Cancer (S0217)

Primary Purpose

Head and Neck Cancer

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cisplatin
docetaxel
radiation therapy
Sponsored by
SWOG Cancer Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral 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, stage III salivary gland cancer, stage IV salivary gland cancer, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, salivary gland squamous cell carcinoma

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Diagnosis of squamous cell carcinoma of the head and neck Selected stage III or IV (no distant metastasis) disease The following TNM stages are excluded: T3, N0, M0 T4a, N0, M0 T4b, N3, M0 Any T, any N, M1 Complete total resection within the past 56 days AND has one or more of the following risk factors: Multiple pathologically confirmed lymph node metastases One or more lymph nodes with extracapsular extension of tumor Microscopically positive margin(s) of resection, including mucosal margins and/or soft tissue or deep margins of resection No primary nasopharyngeal carcinoma PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-1 Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 8.0 g/dL Hepatic Bilirubin ≤ 2 times upper limit of normal (ULN) SGOT or SGPT ≤ 1.5 times ULN Alkaline phosphatase ≤ 2.5 times ULN Renal Creatinine ≤ 1.5 mg/dL OR Creatinine clearance ≥ 60 mL/min Other No pre-existing peripheral neuropathy No known history of severe hypersensitiviy reaction to products containing Polysorbate 80 No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy for the malignancy Endocrine therapy Not specified Radiotherapy No prior radiotherapy for the malignancy Surgery See Disease Characteristics Other No concurrent amifostine

Sites / Locations

  • USC/Norris Comprehensive Cancer Center and Hospital
  • Decatur Memorial Hospital Cancer Care Institute
  • Regional Cancer Center at Memorial Medical Center
  • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
  • Feist-Weiller Cancer Center at Louisiana State University Health Sciences
  • University of Michigan Comprehensive Cancer Center
  • University of Mississippi Medical Center
  • Saint Louis University Cancer Center
  • Rutherford Hospital
  • Adena Regional Medical Center
  • Cleveland Clinic Taussig Cancer Center
  • Riverside Methodist Hospital Cancer Care
  • CCOP - Columbus
  • Grant Riverside Cancer Services
  • Mount Carmel Health - West Hospital
  • Doctors Hospital at Ohio Health
  • Grady Memorial Hospital
  • Community Oncology Group at Cleveland Clinic Cancer Center
  • Fairfield Medical Center
  • Strecker Cancer Center at Marietta Memorial Hospital
  • Licking Memorial Cancer Care Program at Licking Memorial Hospital
  • Mercy Medical Center
  • Community Hospital of Springfield and Clark County
  • Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
  • Cleveland Clinic - Wooster
  • Genesis - Good Samaritan Hospital
  • AnMed Health Cancer Center
  • CCOP - Upstate Carolina
  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

chemoRT after surgery

Arm Description

chemoRT with cisplatin and docetaxel after surgery

Outcomes

Primary Outcome Measures

Disease progression
Disease-free survival
Symptomatic deterioration
Toxicity

Secondary Outcome Measures

Full Information

First Posted
June 10, 2004
Last Updated
June 13, 2012
Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00084435
Brief Title
S0217, Adjuvant Cisplatin and Docetaxel After Complete Resection Stage III or IV Head and Neck Cancer
Acronym
S0217
Official Title
Adjuvant Chemo-RT With Cisplatin (NSC-119875) and Docetaxel (NSC-628503) After Complete Resection of Locally Advanced (Stage III and IV) Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Poor accrual and suspension of head and neck committee
Study Start Date
July 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Cisplatin and docetaxel may make the tumor cells more sensitive to radiation therapy. Giving chemoradiotherapy after surgery may kill any remaining tumor cells. PURPOSE: This phase II trial is studying how well adjuvant chemoradiotherapy using cisplatin and docetaxel works in treating patients with completely resected stage III or stage IV head and neck cancer.
Detailed Description
OBJECTIVES: Determine the disease-free survival and overall survival of patients with high-risk stage III or IV squamous cell carcinoma of the head and neck treated with adjuvant chemoradiotherapy comprising docetaxel and cisplatin. Determine the toxicity of this regimen in these patients. Categorize the site(s) of disease relapse in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 1 hour on days 1, 8, 15, 22, 29, and 36 and cisplatin IV over 1.5 hours on days 1, 22, and 43. Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-45. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 3 years from registration. PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study within 17.5-23.5 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral 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, stage III salivary gland cancer, stage IV salivary gland cancer, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, salivary gland squamous cell carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
chemoRT after surgery
Arm Type
Experimental
Arm Description
chemoRT with cisplatin and docetaxel after surgery
Intervention Type
Drug
Intervention Name(s)
cisplatin
Other Intervention Name(s)
platinol
Intervention Description
75 mg/m2 IV, Day 1, q 21 days for 3 cycles
Intervention Type
Drug
Intervention Name(s)
docetaxel
Other Intervention Name(s)
taxotere
Intervention Description
15 mg/m2 IV, Day 1, 1 7 days for 6 doses
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Other Intervention Name(s)
RT
Intervention Description
200 cGy/day, Days 1-5, q week for 6 weeks
Primary Outcome Measure Information:
Title
Disease progression
Title
Disease-free survival
Title
Symptomatic deterioration
Title
Toxicity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of squamous cell carcinoma of the head and neck Selected stage III or IV (no distant metastasis) disease The following TNM stages are excluded: T3, N0, M0 T4a, N0, M0 T4b, N3, M0 Any T, any N, M1 Complete total resection within the past 56 days AND has one or more of the following risk factors: Multiple pathologically confirmed lymph node metastases One or more lymph nodes with extracapsular extension of tumor Microscopically positive margin(s) of resection, including mucosal margins and/or soft tissue or deep margins of resection No primary nasopharyngeal carcinoma PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-1 Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 8.0 g/dL Hepatic Bilirubin ≤ 2 times upper limit of normal (ULN) SGOT or SGPT ≤ 1.5 times ULN Alkaline phosphatase ≤ 2.5 times ULN Renal Creatinine ≤ 1.5 mg/dL OR Creatinine clearance ≥ 60 mL/min Other No pre-existing peripheral neuropathy No known history of severe hypersensitiviy reaction to products containing Polysorbate 80 No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy for the malignancy Endocrine therapy Not specified Radiotherapy No prior radiotherapy for the malignancy Surgery See Disease Characteristics Other No concurrent amifostine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prakash C. Neupane, MD
Organizational Affiliation
St. Mary's Cancer Specialists at St. Mary's Health Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Harold E. Kim, MD
Organizational Affiliation
Barbara Ann Karmanos Cancer Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Stephen K. Williamson, MD
Organizational Affiliation
University of Kansas
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
George H. Yoo, MD
Organizational Affiliation
Barbara Ann Karmanos Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089-9181
Country
United States
Facility Name
Decatur Memorial Hospital Cancer Care Institute
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Regional Cancer Center at Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62781-0001
Country
United States
Facility Name
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7357
Country
United States
Facility Name
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130-3932
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0942
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Saint Louis University Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Rutherford Hospital
City
Rutherfordton
State/Province
North Carolina
ZIP/Postal Code
28139
Country
United States
Facility Name
Adena Regional Medical Center
City
Chillicothe
State/Province
Ohio
ZIP/Postal Code
45601
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Riverside Methodist Hospital Cancer Care
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214-3998
Country
United States
Facility Name
CCOP - Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Grant Riverside Cancer Services
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Mount Carmel Health - West Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43222
Country
United States
Facility Name
Doctors Hospital at Ohio Health
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43228
Country
United States
Facility Name
Grady Memorial Hospital
City
Delaware
State/Province
Ohio
ZIP/Postal Code
43015
Country
United States
Facility Name
Community Oncology Group at Cleveland Clinic Cancer Center
City
Independence
State/Province
Ohio
ZIP/Postal Code
44131
Country
United States
Facility Name
Fairfield Medical Center
City
Lancaster
State/Province
Ohio
ZIP/Postal Code
43130
Country
United States
Facility Name
Strecker Cancer Center at Marietta Memorial Hospital
City
Marietta
State/Province
Ohio
ZIP/Postal Code
45750
Country
United States
Facility Name
Licking Memorial Cancer Care Program at Licking Memorial Hospital
City
Newark
State/Province
Ohio
ZIP/Postal Code
43055
Country
United States
Facility Name
Mercy Medical Center
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45504
Country
United States
Facility Name
Community Hospital of Springfield and Clark County
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45505
Country
United States
Facility Name
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
City
Westerville
State/Province
Ohio
ZIP/Postal Code
43081
Country
United States
Facility Name
Cleveland Clinic - Wooster
City
Wooster
State/Province
Ohio
ZIP/Postal Code
44691
Country
United States
Facility Name
Genesis - Good Samaritan Hospital
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
AnMed Health Cancer Center
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
CCOP - Upstate Carolina
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States

12. IPD Sharing Statement

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S0217, Adjuvant Cisplatin and Docetaxel After Complete Resection Stage III or IV Head and Neck Cancer

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