Cisplatin Plus Gemcitabine in Treating Patients With Advanced Squamous Cell Head and Neck Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT00003264
First received: November 1, 1999
Last updated: April 16, 2013
Last verified: April 2013
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of cisplatin plus gemcitabine in treating patients with advanced squamous cell head and neck cancer that cannot be treated by surgery or radiation therapy.


Condition Intervention Phase
Head and Neck Cancer
Drug: cisplatin
Drug: gemcitabine hydrochloride
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Evaluation of Weekly Cisplatin and Gemcitabine in the Treatment of Advanced (Recurrent or Metastatic) Carcinoma of the Head and Neck

Resource links provided by NLM:


Further study details as provided by Fox Chase Cancer Center:

Enrollment: 22
Study Start Date: October 1997
Study Completion Date: June 2002
Primary Completion Date: February 2002 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003264

Locations
United States, New Jersey
Hunterdon Regional Cancer Center
Flemington, New Jersey, United States, 08822
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
Mount Holly, New Jersey, United States, 08060
Riverview Medical Center - Booker Cancer Center
Red Bank, New Jersey, United States, 07701
St. Francis Medical Center
Trenton, New Jersey, United States, 08629
United States, Pennsylvania
St. Luke's Network - Bethlehem
Bethlehem, Pennsylvania, United States, 18015
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States, 19026
Harrisburg Polyclinic Medical Center
Harrisburg, Pennsylvania, United States, 17101
Saint Mary Regional Center
Langhorne, Pennsylvania, United States, 19047
North Penn Hospital
Lansdale, Pennsylvania, United States, 19446-1200
Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301-1792
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
Sponsors and Collaborators
Fox Chase Cancer Center
Investigators
Study Chair: Corey J. Langer, MD Fox Chase Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003264     History of Changes
Other Study ID Numbers: CDR0000066159, P30CA006927, FCCC-97021, NCI-G98-1403
Study First Received: November 1, 1999
Last Updated: April 16, 2013
Health Authority: United States: Federal Government

Keywords provided by Fox Chase Cancer Center:
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Gemcitabine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on April 23, 2014