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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


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

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Trial Information

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


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.

Inclusion 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

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:

CDR0000068770

NCT ID:

NCT00021333

Start Date:

September 1999

Completion Date:

May 2008

Related Keywords:

  • Head and Neck Cancer
  • Lung Cancer
  • 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
  • Head and Neck Neoplasms
  • Lung Neoplasms

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Community Medical CenterToms River, New Jersey  08755
St. Francis Medical CenterTrenton, New Jersey  08629
Delaware County Memorial HospitalDrexel Hill, Pennsylvania  19026
Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
South Jersey Regional Cancer CenterMillville, New Jersey  08332
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington CountyMount Holly, New Jersey  08060
Hunterdon Regional Cancer CenterFlemington, New Jersey  08822
Kimball Medical CenterLakewood, New Jersey  08701
Riverview Medical Center - Booker Cancer CenterRed Bank, New Jersey  07701
Saint Mary Regional CenterLanghorne, Pennsylvania  19047
Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
Pinnacle Health HospitalsHarrisburg, Pennsylvania  17105-8700
Conemaugh Memorial HospitalJohnstown, Pennsylvania  15905
Pottstown Memorial Regional Cancer CenterPottstown, Pennsylvania  19464
Bon Secours-Holy Family Health SystemAltoona, Pennsylvania  16602
Central Montgomery Medical CenterLansdale, Pennsylvania  19446-1200
Southern Chester County Medical CenterWest Grove, Pennsylvania  19390