Clinical trial NCT00021333: Paclitaxel and Cisplatin Plus Radiation Therapy Followed by Filgrastim in Treating Patients With Recurrent Head and Neck Cancer or Lung Cancer
Official title: Phase II Evaluation Of Paclitaxel And Cisplatin In Combination With Split Course Hyperfractionated Radiation Therapy And Granulocyte-Colony Stimulating Factor In Previously Irradiated Patients With Locally Recurrent Carcinoma Of The Head And Neck, And Lung
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Lung Cancer
Keywords: recurrent non-small cell lung cancer
recurrent small cell lung cancer
recurrent thyroid cancer
recurrent salivary gland cancer
recurrent squamous cell carcinoma of the lip and oral cavity
recurrent basal cell carcinoma of the lip
recurrent verrucous carcinoma of the oral cavity
recurrent mucoepidermoid carcinoma of the oral cavity
recurrent adenoid cystic carcinoma of the oral cavity
recurrent squamous cell carcinoma of the oropharynx
recurrent lymphoepithelioma of the oropharynx
recurrent squamous cell carcinoma of the nasopharynx
recurrent lymphoepithelioma of the nasopharynx
recurrent squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the larynx
recurrent verrucous carcinoma of the larynx
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
recurrent inverted papilloma of the paranasal sinus and nasal cavity
recurrent midline lethal granuloma of the paranasal sinus and nasal cavity
recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-01-14
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may make tumor cells more sensitive to radiation therapy.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel and cisplatin plus radiation therapy followed by filgrastim in treating patients who have recurrent head and neck cancer or lung cancer.

Detailed description: OBJECTIVES: I. Determine the response rate of patients with locally recurrent carcinoma of the head and neck or lung treated with paclitaxel and cisplatin with concurrent radiotherapy followed by filgrastim (G-CSF). II. Assess the toxicity of this regimen in these patients. III. Determine the time to progression and the sites and pattern of progression in patients treated with this regimen. IV. Determine the median, 1-year, and 2-year survival rates of patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to disease (squamous cell carcinoma of the head and neck vs salivary gland malignancy or other non-squamous cell carcinoma of the head and neck vs lung cancer). Patients receive paclitaxel IV over 1 hour and cisplatin IV over 30-120 minutes on days 1-5. Patients undergo radiotherapy twice daily on days 1-5. Patients receive filgrastim (G-CSF) subcutaneously on days 6-13 or until blood counts recover. Treatment repeats every 2 weeks for a total of 4 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 42-84 patients (14-28 per stratum) will be accrued for this study within 2-4 years.

Eligibility criteria: DISEASE CHARACTERISTICS: Diagnosis of 1 of the following: Previously irradiated, locally recurrent squamous cell carcinoma of the head and neck (SCCHN) or head and neck skin/appendages with no distant metastases New second or subsequent primary SCCHN in a previously irradiated field with no distant metastases Salivary gland malignancy or other non-squamous cell primary head and neck cancer Previously irradiated, locally recurrent carcinoma of the lung No clinical evidence of symptomatic bone or brain metastases requiring radiotherapy No leptomeningeal metastases requiring intrathecal therapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 3 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No active, uncontrolled congestive heart failure or arrhythmia within the past 6 months Other: No pre-existing neuropathy grade 2 or greater interfering with daily activities No prior allergy to drugs using Cremophor EL No hypersensitivity to E. coli-derived proteins No significant concurrent medical or psychiatric disorder that would preclude study No other condition that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 3 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 3 months since prior radiotherapy Prior or concurrent cumulative radiotherapy dose to spinal cord no greater than 5,000 cGy Surgery: Not specified Other: Concurrent beta-blockers, digitalis derivatives, or calcium-channel blocking agents allowed if cardiac conditions are stable

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Flemington
country: United States
facility: Hunterdon Regional Cancer Center
state: New Jersey
city: Lakewood
country: United States
facility: Kimball Medical Center
state: New Jersey
city: Millville
country: United States
facility: South Jersey Regional Cancer Center
state: New Jersey
city: Mount Holly
country: United States
facility: Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County
state: New Jersey
city: Red Bank
country: United States
facility: Riverview Medical Center - Booker Cancer Center
state: New Jersey
city: Toms River
country: United States
facility: Community Medical Center
state: New Jersey
city: Trenton
country: United States
facility: St. Francis Medical Center
state: New Jersey
city: Altoona
country: United States
facility: Bon Secours-Holy Family Health System
state: Pennsylvania
city: Drexel Hill
country: United States
facility: Delaware County Memorial Hospital
state: Pennsylvania
city: Harrisburg
country: United States
facility: Pinnacle Health Hospitals
state: Pennsylvania
city: Johnstown
country: United States
facility: Conemaugh Memorial Hospital
state: Pennsylvania
city: Langhorne
country: United States
facility: Saint Mary Regional Center
state: Pennsylvania
city: Lansdale
country: United States
facility: Central Montgomery Medical Center
state: Pennsylvania
city: Paoli
country: United States
facility: Paoli Memorial Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pottstown
country: United States
facility: Pottstown Memorial Regional Cancer Center
state: Pennsylvania
city: Reading
country: United States
facility: Reading Hospital and Medical Center
state: Pennsylvania
city: West Grove
country: United States
facility: Southern Chester County Medical Center
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Corey J. Langer, MD
role: STUDY_CHAIR
References: