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

NCT00003264 | Completed Phase 2

• 4 other identifiers: CDR0000066159P30CA006927FCCC-97021NCI-G98-1403
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 12

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.

Conditions

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

Interventions

cisplatin DRUG

gemcitabine hydrochloride DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (12)

Hunterdon Regional Cancer Center

Flemington, New Jersey, 08822, United States

Location

Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County

Mount Holly, New Jersey, 08060, United States

Location

Riverview Medical Center - Booker Cancer Center

Red Bank, New Jersey, 07701, United States

Location

St. Francis Medical Center

Trenton, New Jersey, 08629, United States

Location

St. Luke's Network - Bethlehem

Bethlehem, Pennsylvania, 18015, United States

Location

Delaware County Memorial Hospital

Drexel Hill, Pennsylvania, 19026, United States

Location

Harrisburg Polyclinic Medical Center

Harrisburg, Pennsylvania, 17101, United States

Location

Saint Mary Regional Center

Langhorne, Pennsylvania, 19047, United States

Location

North Penn Hospital

Lansdale, Pennsylvania, 19446-1200, United States

Location

Paoli Memorial Hospital

Paoli, Pennsylvania, 19301-1792, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Reading Hospital and Medical Center

Reading, Pennsylvania, 19612-6052, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Salivary Gland Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Cisplatin; Gemcitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Corey J. Langer, MD

  Fox Chase Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: March 1, 2004
• Study Start: October 1, 1997
• Primary Completion: February 1, 2002
• Study Completion: June 1, 2002
• Last Updated: April 17, 2013

Record last verified: 2013-04

Locations

US (12)