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Cisplatin With or Without Monoclonal Antibody Therapy in Treating Patients With Metastatic or Recurrent Head and Neck Cancer

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
cetuximab
cisplatin
Sponsored by
Eastern Cooperative Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring untreated metastatic squamous neck cancer with occult primary, recurrent metastatic squamous neck cancer with occult primary, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically proven squamous cell carcinoma of the head and neck that is incurable with surgery or radiotherapy No nasopharyngeal primaries Measurable or evaluable disease Newly diagnosed with extensive, incurable local regional disease AND distant metastases OR Local regional recurrence/persistence or distant metastases after surgery or radiotherapy Persistent or progressive disease after radiotherapy must be histologically proven at least 8 weeks after therapy No brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT and SGPT no greater than 2 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2 times ULN Renal: Creatinine no greater than 1.2 mg/dL OR Creatinine clearance at least 50 mL/min Calcium no greater than ULN No history of hypercalcemia Other: No active infection No other concurrent malignancy within past 2 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No known hypersensitivity to murine proteins Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior chimeric antibody or kinase inhibitor for recurrent or metastatic disease No more than 1 prior biotherapy regimen for recurrent or metastatic disease Chemotherapy: At least 3 months since prior induction or adjuvant chemotherapy concurrent with radiotherapy No prior chemotherapy for recurrent disease Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics Recovered from prior major surgery

Sites / Locations

  • CCOP - Scottsdale Oncology Program
  • Mayo Clinic Scottsdale
  • Beckman Research Institute, City of Hope
  • Veterans Affairs Medical Center - Palo Alto
  • Stanford University Medical Center
  • CCOP - Colorado Cancer Research Program, Inc.
  • Yale Comprehensive Cancer Center
  • CCOP - Christiana Care Health Services
  • Walter Reed Army Medical Center
  • Veterans Affairs Medical Center - Gainsville
  • Sylvester Cancer Center, University of Miami
  • H. Lee Moffitt Cancer Center and Research Institute
  • Veterans Affairs Medical Center - Tampa (Haley)
  • Emory University Hospital - Atlanta
  • Veterans Affairs Medical Center - Atlanta (Decatur)
  • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
  • Veterans Affairs Medical Center - Lakeside Chicago
  • CCOP - Central Illinois
  • CCOP - Evanston
  • CCOP - Illinois Oncology Research Association
  • CCOP - Carle Cancer Center
  • Indiana University Cancer Center
  • Veterans Affairs Medical Center - Indianapolis (Roudebush)
  • CCOP - Cedar Rapids Oncology Project
  • CCOP - Iowa Oncology Research Association
  • CCOP - Wichita
  • MBCCOP - LSU Medical Center
  • CCOP - Ochsner
  • Johns Hopkins Oncology Center
  • New England Medical Center Hospital
  • Beth Israel Deaconess Medical Center
  • CCOP - Ann Arbor Regional
  • CCOP - Kalamazoo
  • CCOP - Duluth
  • Veterans Affairs Medical Center - Minneapolis
  • Mayo Clinic Cancer Center
  • CCOP - Metro-Minnesota
  • CCOP - Missouri Valley Cancer Consortium
  • CCOP - Southern Nevada Cancer Research Foundation
  • CCOP - Northern New Jersey
  • Hackensack University Medical Center
  • Cancer Institute of New Jersey
  • Riverview Medical Center
  • St. Francis Medical Center
  • Veterans Affairs Medical Center - Albany
  • Albert Einstein Comprehensive Cancer Center
  • Veterans Affairs Medical Center - Brooklyn
  • Veterans Affairs Medical Center - New York
  • NYU School of Medicine's Kaplan Comprehensive Cancer Center
  • University of Rochester Cancer Center
  • CCOP - Merit Care Hospital
  • Ireland Cancer Center
  • Veterans Affairs Medical Center - Cleveland
  • CCOP - Columbus
  • CCOP - Toledo Community Hospital Oncology Program
  • CCOP - Sooner State
  • CCOP - Geisinger Clinic and Medical Center
  • Penn State Geisinger Cancer Center
  • Hahnemann University Hospital
  • University of Pennsylvania Cancer Center
  • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
  • Fox Chase Cancer Center
  • University of Pittsburgh Cancer Institute
  • Veterans Affairs Medical Center - Pittsburgh
  • CCOP - MainLine Health
  • CCOP - Sioux Community Cancer Consortium
  • Veterans Affairs Medical Center - Nashville
  • Vanderbilt-Ingram Cancer Center
  • Veterans Affairs Medical Center - Madison
  • University of Wisconsin Comprehensive Cancer Center
  • CCOP - Marshfield Medical Research and Education Foundation
  • Medical College of Wisconsin
  • Veterans Affairs Medical Center - Milwaukee (Zablocki)
  • MBCCOP - San Juan
  • Veterans Affairs Medical Center - San Juan
  • Pretoria Academic Hospitals

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
June 20, 2023
Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003809
Brief Title
Cisplatin With or Without Monoclonal Antibody Therapy in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
Official Title
Randomized, Double Blind, Placebo Controlled Phase III Evaluation of Cisplatin + Placebo Versus Cisplatin + C225 a Mouse/Human Monoclonal Antibody to the Epidermal Growth Factor Receptor, in Patients With Metastatic and/or Recurrent Squamous Cell Cancer of the Head and Neck
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
August 6, 1999 (Actual)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
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3. Sponsor/Collaborators

Name of the Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate cancer cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether cisplatin plus monoclonal antibody therapy is more effective than cisplatin alone for metastatic or recurrent head and neck cancer. PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of cisplatin with or without monoclonal antibody in treating patients who have metastatic or recurrent head and neck cancer.
Detailed Description
OBJECTIVES: I. Compare the efficacy (survival and response rates) and toxicity of cisplatin with or without monoclonal antibody C225 in patients with metastatic and/or recurrent squamous cell head and neck cancer. II. Compare the correlation between epidermal growth factor receptor density and response and progression-free survival in these patients. III. Determine the steady state serum levels of monoclonal antibody C225 and the frequency of human antibody response to this monoclonal antibody in patients treated with the combination therapy. OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to disease status (newly diagnosed vs recurrent) and ECOG status (0 vs 1). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive monoclonal antibody C225 IV over 2 hours followed 1 hour later by cisplatin IV over 2 hours on day 1 of course 1. Monoclonal antibody C225 is administered over 1 hour on subsequent courses. Arm II: Patients receive placebo IV over 2 hours followed 1 hour later by cisplatin as in arm I on day 1 of course 1. Placebo is administered over 1 hour on subsequent courses. Treatment continues every 4 weeks for at least 6 courses in the absence of disease progression or unacceptable toxicity. Arm II patients who develop disease progression may then crossover to arm I treatment. Patients are followed at 1 and 3 months and then every 3 months until disease progression. PROJECTED ACCRUAL: A total of 114 patients will be accrued for this study within 14 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
untreated metastatic squamous neck cancer with occult primary, recurrent metastatic squamous neck cancer with occult primary, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
cetuximab
Intervention Type
Drug
Intervention Name(s)
cisplatin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven squamous cell carcinoma of the head and neck that is incurable with surgery or radiotherapy No nasopharyngeal primaries Measurable or evaluable disease Newly diagnosed with extensive, incurable local regional disease AND distant metastases OR Local regional recurrence/persistence or distant metastases after surgery or radiotherapy Persistent or progressive disease after radiotherapy must be histologically proven at least 8 weeks after therapy No brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT and SGPT no greater than 2 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2 times ULN Renal: Creatinine no greater than 1.2 mg/dL OR Creatinine clearance at least 50 mL/min Calcium no greater than ULN No history of hypercalcemia Other: No active infection No other concurrent malignancy within past 2 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No known hypersensitivity to murine proteins Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior chimeric antibody or kinase inhibitor for recurrent or metastatic disease No more than 1 prior biotherapy regimen for recurrent or metastatic disease Chemotherapy: At least 3 months since prior induction or adjuvant chemotherapy concurrent with radiotherapy No prior chemotherapy for recurrent disease Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics Recovered from prior major surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara A. Burtness, MD
Organizational Affiliation
Yale University
Official's Role
Study Chair
Facility Information:
Facility Name
CCOP - Scottsdale Oncology Program
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259-5404
Country
United States
Facility Name
Mayo Clinic Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Beckman Research Institute, City of Hope
City
Los Angeles
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Veterans Affairs Medical Center - Palo Alto
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5408
Country
United States
Facility Name
CCOP - Colorado Cancer Research Program, Inc.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209-5031
Country
United States
Facility Name
Yale Comprehensive Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8028
Country
United States
Facility Name
CCOP - Christiana Care Health Services
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19899
Country
United States
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307-5000
Country
United States
Facility Name
Veterans Affairs Medical Center - Gainsville
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608-1197
Country
United States
Facility Name
Sylvester Cancer Center, University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Veterans Affairs Medical Center - Tampa (Haley)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Emory University Hospital - Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Veterans Affairs Medical Center - Atlanta (Decatur)
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Veterans Affairs Medical Center - Lakeside Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
CCOP - Central Illinois
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
CCOP - Evanston
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
CCOP - Illinois Oncology Research Association
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
CCOP - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5265
Country
United States
Facility Name
Veterans Affairs Medical Center - Indianapolis (Roudebush)
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
CCOP - Cedar Rapids Oncology Project
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403-1206
Country
United States
Facility Name
CCOP - Iowa Oncology Research Association
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309-1016
Country
United States
Facility Name
CCOP - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214-3882
Country
United States
Facility Name
MBCCOP - LSU Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
CCOP - Ochsner
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Johns Hopkins Oncology Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
New England Medical Center Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
CCOP - Ann Arbor Regional
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
CCOP - Kalamazoo
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
CCOP - Duluth
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Veterans Affairs Medical Center - Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
CCOP - Metro-Minnesota
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
CCOP - Missouri Valley Cancer Consortium
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
CCOP - Southern Nevada Cancer Research Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
CCOP - Northern New Jersey
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Riverview Medical Center
City
Red Bank
State/Province
New Jersey
ZIP/Postal Code
07701
Country
United States
Facility Name
St. Francis Medical Center
City
Trenton
State/Province
New Jersey
ZIP/Postal Code
08629
Country
United States
Facility Name
Veterans Affairs Medical Center - Albany
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Albert Einstein Comprehensive Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Veterans Affairs Medical Center - Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11209
Country
United States
Facility Name
Veterans Affairs Medical Center - New York
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
NYU School of Medicine's Kaplan Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
University of Rochester Cancer Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
CCOP - Merit Care Hospital
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
Veterans Affairs Medical Center - Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
CCOP - Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43206
Country
United States
Facility Name
CCOP - Toledo Community Hospital Oncology Program
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623-3456
Country
United States
Facility Name
CCOP - Sooner State
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
CCOP - Geisinger Clinic and Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-2001
Country
United States
Facility Name
Penn State Geisinger Cancer Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Hahnemann University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102-1192
Country
United States
Facility Name
University of Pennsylvania Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
University of Pittsburgh Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Veterans Affairs Medical Center - Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Facility Name
CCOP - MainLine Health
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
CCOP - Sioux Community Cancer Consortium
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105-1080
Country
United States
Facility Name
Veterans Affairs Medical Center - Nashville
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States
Facility Name
Veterans Affairs Medical Center - Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
CCOP - Marshfield Medical Research and Education Foundation
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Veterans Affairs Medical Center - Milwaukee (Zablocki)
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53295
Country
United States
Facility Name
MBCCOP - San Juan
City
San Juan
ZIP/Postal Code
00927-5800
Country
Puerto Rico
Facility Name
Veterans Affairs Medical Center - San Juan
City
San Juan
ZIP/Postal Code
00927-5800
Country
Puerto Rico
Facility Name
Pretoria Academic Hospitals
City
Pretoria
ZIP/Postal Code
0001
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
16314626
Citation
Burtness B, Goldwasser MA, Flood W, Mattar B, Forastiere AA; Eastern Cooperative Oncology Group. Phase III randomized trial of cisplatin plus placebo compared with cisplatin plus cetuximab in metastatic/recurrent head and neck cancer: an Eastern Cooperative Oncology Group study. J Clin Oncol. 2005 Dec 1;23(34):8646-54. doi: 10.1200/JCO.2005.02.4646. Erratum In: J Clin Oncol. 2006 Feb 1;24(4):724.
Results Reference
result
Citation
Burtness BA, Li Yi, Flood W, et al.: Phase III trial comparing cisplatin (C) + placebo (P) to C + anti-epidermal growth factor antibody (EGF-R) C225 in patients (pts) with metastatic/recurrent head & neck cancer (HNC). [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-901, 2002.
Results Reference
result
PubMed Identifier
25081901
Citation
Chung CH, Lee JW, Slebos RJ, Howard JD, Perez J, Kang H, Fertig EJ, Considine M, Gilbert J, Murphy BA, Nallur S, Paranjape T, Jordan RC, Garcia J, Burtness B, Forastiere AA, Weidhaas JB. A 3'-UTR KRAS-variant is associated with cisplatin resistance in patients with recurrent and/or metastatic head and neck squamous cell carcinoma. Ann Oncol. 2014 Nov;25(11):2230-2236. doi: 10.1093/annonc/mdu367. Epub 2014 Jul 31. Erratum In: Ann Oncol. 2015 May;26(5):1038-9.
Results Reference
derived

Learn more about this trial

Cisplatin With or Without Monoclonal Antibody Therapy in Treating Patients With Metastatic or Recurrent Head and Neck Cancer

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