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

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cisplatin
gemcitabine hydrochloride
Sponsored by
Fox Chase Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring 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

Eligibility Criteria

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

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

Sites / Locations

  • Hunterdon Regional Cancer Center
  • Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
  • Riverview Medical Center - Booker Cancer Center
  • St. Francis Medical Center
  • St. Luke's Network - Bethlehem
  • Delaware County Memorial Hospital
  • Harrisburg Polyclinic Medical Center
  • Saint Mary Regional Center
  • North Penn Hospital
  • Paoli Memorial Hospital
  • Fox Chase Cancer Center
  • Reading Hospital and Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
April 16, 2013
Sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003264
Brief Title
Cisplatin Plus Gemcitabine in Treating Patients With Advanced Squamous Cell Head and Neck Cancer
Official Title
Phase II Evaluation of Weekly Cisplatin and Gemcitabine in the Treatment of Advanced (Recurrent or Metastatic) Carcinoma of the Head and Neck
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
October 1997 (undefined)
Primary Completion Date
February 2002 (Actual)
Study Completion Date
June 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corey J. Langer, MD
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Hunterdon Regional Cancer Center
City
Flemington
State/Province
New Jersey
ZIP/Postal Code
08822
Country
United States
Facility Name
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
City
Mount Holly
State/Province
New Jersey
ZIP/Postal Code
08060
Country
United States
Facility Name
Riverview Medical Center - Booker Cancer 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
St. Luke's Network - Bethlehem
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Delaware County Memorial Hospital
City
Drexel Hill
State/Province
Pennsylvania
ZIP/Postal Code
19026
Country
United States
Facility Name
Harrisburg Polyclinic Medical Center
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17101
Country
United States
Facility Name
Saint Mary Regional Center
City
Langhorne
State/Province
Pennsylvania
ZIP/Postal Code
19047
Country
United States
Facility Name
North Penn Hospital
City
Lansdale
State/Province
Pennsylvania
ZIP/Postal Code
19446-1200
Country
United States
Facility Name
Paoli Memorial Hospital
City
Paoli
State/Province
Pennsylvania
ZIP/Postal Code
19301-1792
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Reading Hospital and Medical Center
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19612-6052
Country
United States

12. IPD Sharing Statement

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

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