Paclitaxel, Cisplatin, and Filgrastim Combined With Radiation Therapy in Treating Patients With Locally Recurrent Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT00005087|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : November 17, 2015
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. Radiation therapy uses high-energy x-rays to damage tumor cells.
PURPOSE: Phase II trial to study the effectiveness of paclitaxel, cisplatin, and filgrastim combined with radiation therapy in treating patients who have locally recurrent head and neck cancer and have received previous treatment with radiation therapy.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Biological: filgrastim Drug: cisplatin Drug: paclitaxel Procedure: conventional surgery Radiation: radiation therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||105 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2000|
|Actual Primary Completion Date :||November 2004|
|Actual Study Completion Date :||November 2013|
Experimental: Radiation (BID) and chemotherapy
Radiation (BID), cisplatin and paclitaxel given on days 1-5 (Monday-Friday) in weeks 1, 3, 5 and 7. G-CSF given on days 6-13.
Procedure: conventional surgery
Radiation: radiation therapy
- Overall Survival [ Time Frame: From registration to 1 year ]
- Disease-free Survival [ Time Frame: From registration to 1 year ]
- Grade 4-5 toxicity [ Time Frame: From one year after the start of radiation therapy to last follow-up. ]
- Pattern of failure (local-regional, distant, new primary, death) [ Time Frame: From registration to last follow-up. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005087
Show 235 Study Locations
|Study Chair:||Corey J. Langer, MD||Fox Chase Cancer Center|