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Phase II Evaluation of Weekly Cisplatin and Gemcitabine in the Treatment of Advanced (Recurrent or Metastatic) Carcinoma of the Head and Neck


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

Thank you

Trial Information

Phase II Evaluation of Weekly Cisplatin and Gemcitabine in the Treatment of Advanced (Recurrent or Metastatic) Carcinoma of the Head and Neck


OBJECTIVES: I. Evaluate the response rate and toxicity of weekly cisplatin and gemcitabine
in patients with recurrent or metastatic squamous cell carcinoma of the head and neck who
have received either no prior chemotherapy or no more than one prior chemotherapy regimen
for advanced disease.

OUTLINE: Patients are stratified according to prior chemotherapy status: chemotherapy naive
(no prior chemotherapy, or prior neoadjuvant or adjuvant chemotherapy at least 6 months
prior to recurrence, or prior biologic agents only) vs chemotherapy exposed (one prior
chemotherapy regimen directed at recurrent or newly diagnosed metastatic disease and/or
prior neoadjuvant or adjuvant chemotherapy less than 6 months prior to recurrence). Patients
receive gemcitabine as a 30 minute infusion weekly for 3 weeks followed by one week of rest.
Cisplatin is administered as a 30-60 minute infusion immediately preceding gemcitabine.
Treatment repeats every 28 days for 2-6 courses, depending on response. Patients with
previously untreated metastatic disease may have treatment interrupted to receive radiation
therapy to locoregional disease sites. Patients may continue treatment beyond 6 courses at
the discretion of the physician. Patients are followed every 3 months.

PROJECTED ACCRUAL: This study will accrue approximately 36 patients.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven squamous cell carcinoma of the head and
neck considered incurable with surgery or radiation therapy Bidimensionally measurable
disease or readily evaluable disease by either physical exam or radiography Biopsy proven
recurrence following completion of radiotherapy required if only site of measurable
disease is within a previous radiation port

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy:
Not specified Hematopoietic: Absolute neutrophil count at least 2000/mm3 Platelet count at
least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no
greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Neurologic: Peripheral
sensory neuropathy no greater than grade 1 Other: No significant active infection
(patients with WBC of 12,000/mm3 or greater, or fever of 100.6 degrees F or higher, must
be evaluated to rule out occult infection) Not pregnant or nursing Effective contraception
required of fertile patients No active second malignancy

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior biologic therapy (interleukin-2,
interferon, monoclonal antibodies, and/or retinoids) permitted Recovered from prior
biologic therapy Chemotherapy: No more than one prior chemotherapy regimen for advanced or
relapsed disease No chemotherapy within 4 weeks prior to study Prior neoadjuvant or
radiosensitizing chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: Prior
radiotherapy permitted Recovered from prior radiotherapy Surgery: Recovered from major
surgery

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Corey J. Langer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066159

NCT ID:

NCT00003264

Start Date:

October 1997

Completion Date:

June 2002

Related Keywords:

  • Head and Neck Cancer
  • stage IV salivary gland cancer
  • recurrent salivary gland cancer
  • recurrent metastatic squamous neck cancer with occult primary
  • metastatic squamous neck cancer with occult primary squamous cell carcinoma
  • salivary gland squamous cell carcinoma
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • recurrent squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the oropharynx
  • recurrent squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the nasopharynx
  • recurrent squamous cell carcinoma of the nasopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • recurrent squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the larynx
  • recurrent squamous cell carcinoma of the larynx
  • 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

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
St. Francis Medical CenterTrenton, New Jersey  08629
Delaware County Memorial HospitalDrexel Hill, Pennsylvania  19026
Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
St. Luke's Network - BethlehemBethlehem, Pennsylvania  18015
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington CountyMount Holly, New Jersey  08060
Hunterdon Regional Cancer CenterFlemington, New Jersey  08822
Riverview Medical Center - Booker Cancer CenterRed Bank, New Jersey  07701
Harrisburg Polyclinic Medical CenterHarrisburg, Pennsylvania  17101
Saint Mary Regional CenterLanghorne, Pennsylvania  19047
North Penn HospitalLansdale, Pennsylvania  19446-1200
Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792