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Phase II Study of Paclitaxel and Cisplatin in Combination With Split Course Concomitant Hyperfractionated Re-Irradiation in Patients With Recurrent Squamous Cell Cancer of the Head and Neck

Phase 2
18 Years
Not Enrolling
Head and Neck Cancer

Thank you

Trial Information

Phase II Study of Paclitaxel and Cisplatin in Combination With Split Course Concomitant Hyperfractionated Re-Irradiation in Patients With Recurrent Squamous Cell Cancer of the Head and Neck


- Determine the median, one-year, and long-term (defined as two-year) disease-free
survival and overall survival in patients with previously irradiated locally recurrent
squamous cell cancer of the head and neck treated with paclitaxel, cisplatin, and
filgrastim (G-CSF) combined with radiotherapy.

- Determine the rates of acute and late toxic effects of this regimen in these patients.

- Determine the pattern of disease progression in patients treated with this regimen.

OUTLINE: Patients undergo radiotherapy twice daily (4-6 hours apart) on days 1-5. Patients
receive paclitaxel IV over 1 hour beginning immediately after completion of the first
fraction of radiotherapy and completing less than 3 hours before starting the second
fraction of radiotherapy on days 1-5. Patients receive cisplatin IV over 30 minutes
beginning immediately after completion of paclitaxel infusion on days 1-5 and filgrastim
(G-CSF) subcutaneously on days 6-13. Treatment repeats every 2 weeks for 4 courses in the
absence of disease progression or unacceptable toxicity. Patients who initially respond to
therapy but develop a recurrence with a resectable lesion (inside or outside the retreatment
field) may undergo surgical resection.

Patients are followed at 4 weeks after completion of radiotherapy, every 3 months for 2
years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 34 months.

Inclusion Criteria


- Histologically proven locally recurrent primary squamous cell cancer (SCC) of the
head and neck or second primary SCC of the head and neck

- More than 1 prior recurrence allowed if the first recurrence occurred at least 6
months after completion of prior radiotherapy

- Disease must be confined to the head and neck (above the clavicles)

- No primary SCC of the nasopharynx or salivary gland

- Prior irradiation of 45-75 Gy to the majority (75% or greater) of tumor volume

- Entire tumor volume must be included in a treatment field that limits the total
spinal cord dose (prior and anticipated) to 50 Gy

- Prior radiotherapy records, including simulation and portal films, available in
order to assure that cord tolerance is not exceeded

- Measurable disease

- Ineligible for complete surgical resection

- No distant metastases



- 18 and over

Performance status:

- Zubrod 0 or 1

Life expectancy:

- No other concurrent illness that would limit survival


- Granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than 1.5 mg/dL

- SGOT and SGPT no greater than 2 times normal*

- Alkaline phosphatase no greater than 2 times normal*

- * Greater than 2 times normal allowed if no metastases by liver ultrasound or CT scan


- Creatinine no greater than 1.5 mg/dL


- No other invasive malignancy within the past 2 years except in situ malignancies
(e.g., carcinoma in situ of the cervix, carcinoma in situ of the breast, or
nonmelanoma skin cancer)

- No other concurrent illness that would impair tolerance to therapy

- No grade 2 or worse pre-existing peripheral sensory neuropathy

- No hypersensitivity to E. coli derived products

- Not pregnant or nursing

- Fertile patients must use effective contraception


Biologic therapy:

- Not specified


- Prior chemotherapy allowed as a component of the primary treatment

- No prior chemotherapy for recurrent disease

- At least 6 months since prior chemotherapy

Endocrine therapy:

- Not specified


- See Disease Characteristics

- At least 6 months since prior radiotherapy


- See Disease Characteristics

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Corey J. Langer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center


United States: Federal Government

Study ID:




Start Date:

March 2000

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • recurrent metastatic squamous neck cancer with occult primary
  • metastatic squamous neck cancer with occult primary squamous cell carcinoma
  • stage I squamous cell carcinoma of the lip and oral cavity
  • stage II squamous cell carcinoma of the lip and oral cavity
  • stage III squamous cell carcinoma of the lip and oral cavity
  • recurrent squamous cell carcinoma of the lip and oral cavity
  • stage I squamous cell carcinoma of the oropharynx
  • stage II squamous cell carcinoma of the oropharynx
  • stage III squamous cell carcinoma of the oropharynx
  • recurrent squamous cell carcinoma of the oropharynx
  • stage I squamous cell carcinoma of the hypopharynx
  • stage II squamous cell carcinoma of the hypopharynx
  • stage III squamous cell carcinoma of the hypopharynx
  • recurrent squamous cell carcinoma of the hypopharynx
  • stage I squamous cell carcinoma of the larynx
  • stage II squamous cell carcinoma of the larynx
  • stage III squamous cell carcinoma of the larynx
  • recurrent squamous cell carcinoma of the larynx
  • stage I squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage II squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
  • recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
  • Neoplasms, Squamous Cell
  • Head and Neck Neoplasms



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