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A Phase II Study of Oxaliplatin in Patients With Advanced Carcinoma of the Head and Neck


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

A Phase II Study of Oxaliplatin in Patients With Advanced Carcinoma of the Head and Neck


OBJECTIVES: I. Determine the response rate of patients with advanced squamous cell carcinoma
of the head and neck when treated with oxaliplatin. II. Characterize the toxicities and
pharmacokinetics of this drug in this patient population. III. Determine the duration of
response, time to progression, and survival of these patients receiving this drug.

OUTLINE: Patients are stratified according to prior treatment with neoadjuvant chemotherapy
(yes vs no). Patients receive oxaliplatin IV over 2 hours weekly for 4 weeks followed by 2
weeks of rest. Treatment continues every 6 weeks in the absence of unacceptable toxicity or
disease progression. Patients are followed until toxicity resolves or for no less than 30
days.

PROJECTED ACCRUAL: A total of 34-74 patients will be accrued for this study within 17
months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically or cytologically confirmed squamous cell carcinoma
of the head and neck Recurrent or metastatic OR Locally advanced and judged incurable by
surgery or radiotherapy Bidimensionally measurable disease New and unirradiated lesion
within prior radiation field acceptable as measurable disease if at least 3 months since
prior radiotherapy No known brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR Karnofsky
50-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Absolute
neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin
normal AST/ALT no greater than 2.5 times upper limit of normal Renal: Creatinine normal OR
Creatinine clearance at least 60 mL/min Cardiovascular: No symptomatic congestive heart
failure, unstable angina pectoris, or cardiac arrhythmia Other: Not pregnant or nursing
Negative pregnancy test Fertile patients must use effective contraception No evidence of
neuropathy No history of allergy to platinum compounds or to antiemetics appropriate for
administration in conjunction with protocol therapy No other concurrent uncontrolled
illness (e.g., ongoing or active infection) Not HIV positive AND receiving antiretroviral
therapy (HAART)

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy for head and neck
cancer No concurrent colony stimulating factors during first course of therapy
Chemotherapy: No prior chemotherapy for recurrent or metastatic disease At least 3 months
since prior chemotherapy as initial treatment Endocrine therapy: No prior hormonal therapy
for head and neck cancer Radiotherapy: See Disease Characteristics At least 3 months since
prior radiotherapy as initial treatment Surgery: See Disease Characteristics Prior surgery
allowed Other: No other concurrent investigational or commercial agents or therapies

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Chris A. Rhoades, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ohio State University Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067571

NCT ID:

NCT00005035

Start Date:

December 1999

Completion Date:

March 2004

Related Keywords:

  • Head and Neck Cancer
  • metastatic squamous neck cancer with occult primary squamous cell carcinoma
  • 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 nasopharynx
  • stage IV squamous cell carcinoma of the nasopharynx
  • recurrent squamous cell carcinoma of the nasopharynx
  • 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
  • Head and Neck Neoplasms

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Lutheran General Cancer Care CenterPark Ridge, Illinois  60068
Evanston Northwestern Health CareEvanston, Illinois  60201
Louis A. Weiss Memorial HospitalChicago, Illinois  60640
Oncology/Hematology Associates of Central Illinois, P.C.Peoria, Illinois  61602
Central Illinois Hematology Oncology CenterSpringfield, Illinois  62701
Fort Wayne Medical Oncology and Hematology, Inc.Fort Wayne, Indiana  46885-5099
Cancer Centers of the CarolinasGreenville, South Carolina  29605
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Saint Joseph's Regional Medical CenterSouth Bend, Indiana  46634-1935