Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Paclitaxel, Cisplatin, and Filgrastim Combined With Radiation Therapy in Treating Patients With Locally Recurrent Head and Neck Cancer

Basic Trial Information

Objectives

1. 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.
2. Determine the rates of acute and late toxic effects of this regimen in these patients.
3. Determine the pattern of disease progression in patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• 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

Radiotherapy:

• See Disease Characteristics
• At least 6 months since prior radiotherapy

Surgery:

• See Disease Characteristics

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Zubrod 0 or 1

Life expectancy:

• No other concurrent illness that would limit survival

Hematopoietic:

• Granulocyte count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic:

• 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

Renal:

• Creatinine no greater than 1.5 mg/dL

Other:

• 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

Expected Enrollment

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

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.

Langer CJ, Harris J, Horwitz EM, et al.: Phase II study of low-dose paclitaxel and cisplatin in combination with split-course concomitant twice-daily reirradiation in recurrent squamous cell carcinoma of the head and neck: results of Radiation Therapy Oncology Group Protocol 9911. J Clin Oncol 25 (30): 4800-5, 2007.[PUBMED Abstract]

Horwitz EM, Harris J, Langer CJ, et al.: Concurrent split course hyperfractionated radiotherapy (Hfx RT), cisplatin (DDP) and paclitaxel (P) in patients with recurrent, previously irradiated squamous cell carcinoma of the head and neck (SCCHN): update of RTOG 9911 . [Abstract] J Clin Oncol 23 (Suppl 16): A-5577, 519s, 2005.

Horwitz EM, Harris J, Langer CJ, et al.: Phase II study of paclitaxel and cisplatin in combination with split course concomitant hyperfractioned re-irradiation in patients with recurrent squamous cell cancer of the head and neck : results of RTOG 99-11. [Abstract] Int J Radiat Oncol Biol Phys 63 (2 Suppl 1): A-119, S72, 2005.

Langer CJ, Harris J, Horwitz E, et al.: Phase II trial of concurrent split course hyperfractionated radiotherapy (Hfx RT), cisplatin (DDP) and paclitaxel (P) in patients with recurrent, previously irradiated squamous cell carcinoma of the head and neck (SCCHN): results of RTOG 9911. [Abstract] J Clin Oncol 22 (Suppl 14): A-5509, 490s, 2004.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

Corey Langer, MD, Protocol chair		Ph: 215-728-2985; 888-369-2427 Email: cj_langer@fccc.edu

Registry Information
Official Title		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
Trial Start Date		2000-03-30
Registered in ClinicalTrials.gov		NCT00005087
Date Submitted to PDQ		2000-02-29
Information Last Verified		2003-05-28
NCI Grant/Contract Number		CA21661

Back to Top