NCT00005814

Brief Summary

RATIONALE: Monoclonal antibodies, such as cetuximab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use 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. Combining chemotherapy with monoclonal antibody therapy and radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining cetuximab, cisplatin, and radiation therapy in treating patients who have advanced stage III or stage IV head and neck cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Dec 1999

Typical duration for phase_2 head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1999

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2000

Completed
4 years until next milestone

First Posted

Study publicly available on registry

May 20, 2004

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

June 19, 2013

Status Verified

June 1, 2013

Enrollment Period

5.8 years

First QC Date

June 2, 2000

Last Update Submit

June 17, 2013

Conditions

Head and Neck Cancer

Keywords

stage III squamous cell carcinoma of the lip and oral cavitystage IV squamous cell carcinoma of the lip and oral cavityrecurrent squamous cell carcinoma of the lip and oral cavitystage III squamous cell carcinoma of the oropharynxstage IV squamous cell carcinoma of the oropharynxrecurrent squamous cell carcinoma of the oropharynxstage III squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the hypopharynxrecurrent squamous cell carcinoma of the hypopharynxstage III squamous cell carcinoma of the larynxstage IV squamous cell carcinoma of the larynxrecurrent squamous cell carcinoma of the larynxstage III squamous cell carcinoma of the paranasal sinus and nasal cavitystage IV squamous cell carcinoma of the paranasal sinus and nasal cavityrecurrent squamous cell carcinoma of the paranasal sinus and nasal cavity

Interventions

cetuximabBIOLOGICAL
cisplatinDRUG
radiation therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Newly diagnosed or recurrent, advanced stage III or IV squamous cell carcinoma of the larynx, hypopharynx, oropharynx, oral cavity, or paranasal sinus/nasal cavity M0 No nasopharyngeal cancer Measurable or evaluable disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Hemoglobin at least 9 g/dL Platelet count at least 100,000/mm3 Hepatic: Alkaline phosphatase no greater than 2.5 times upper limit of normal (ULN) AST no greater than 2.5 times ULN Bilirubin no greater than 1.5 times ULN Renal: Creatinine no greater than 1 times ULN Creatinine clearance at least 60 mL/min Calcium no greater than 11.5 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: No prior murine monoclonal antibody therapy No prior cetuximab No prior immunotherapy Chemotherapy: At least 3 years since prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the head or neck region No other concurrent radiotherapy Surgery: At least 60 days since prior surgery Diagnostic biopsy allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

CetuximabCisplatinRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsTherapeutics

Study Officials

  • Michael J. Zelefsky, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 2, 2000

First Posted

May 20, 2004

Study Start

December 1, 1999

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

June 19, 2013

Record last verified: 2013-06

Locations

US(1)