A Multicenter Study of Intensive Concomitant Chemoradiotherapy With Filgrastim (GCSF) for Patients With Locoregionally Advanced Head and Neck Cancer
This study has been completed.
Information provided by (Responsible Party):
University of Chicago
First received: August 20, 2010
Last updated: September 4, 2013
Last verified: September 2013
The goal of the study is to test a particular combination of drugs and determine their ability to completely eliminate head and neck cancer.
Head and Neck
Drug: 5- Fluorouracil
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Multicenter Phase II Study of Intensive Concomitant Chemoradiotherapy With Filgrastim (GCSF) for Patients With Locoregionally Advanced Head and Neck Cancer
Primary Outcome Measures:
Secondary Outcome Measures:
- Feasibility of administering adjuvant CRA and interferon alfa2a [ Time Frame: 2-5 years ] [ Designated as safety issue: No ]
To determine the feasibility of administering adjuvant CRA and interferon alfa2a for up to one or until tumor progression in patients completing local therapy.
- Side effects of study regimen [ Time Frame: 2-5 years ] [ Designated as safety issue: Yes ]
To determine the pattern and degree of clinical toxicity of this regimen
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2003 (Final data collection date for primary outcome measure)
Hydroxyurea at 1gm(PO)12hrs x 11days(2gm/day). The first daily dose of hydroxyurea on days 1-5 is given 2 hrs prior to the first fraction of daily radiotherapy.
Drug: 5- Fluorouracil
Start continuous infusion of 5-Fluorouracil at 800mg/m2/day x 5 days (120 hrs.
Radiation therapy is administered twice daily at 150 cGY per fraction, every other week with chemotherapy.
Cisplatin 100mg/m2 I.V. on the evening of the day 1, on cycles 1,3,and 5 only in 200cc NS IV over 2 h. Ensure adequate hydration to keep urine output > 100 cc/ hour.
|Ages Eligible for Study:
||59 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients with Stage IV carcinoma of the nasal or oral cavity, nasopharynx pharynx, larynx, paranasal sinuses, cervical esophagus, or hypopharynx are eligible. Patients with Stage III carcinoma of the nasopharynx, base of tongue and hypopharynx are also eligible. Therapy is given with curative intent.
Prior to entry in the study the resectability and standard treatment options for each patient will be determined during a joint evaluation by a team composed of an attending surgeon, a radiation oncologist and a medical oncologist. In addition the timing and feasibility of surgery will be determined in each patient prior to initiation of therapy. The unequivocal demonstration of distant metastasis confers in eligibility.
- Measurable disease is not required, but all disease will be carefully evaluated.
- Patients must have a histologically or cytologically confirmed diagnosis of squamous cell carcinoma or lymphoepithelioma.
- Patients must have not received prior chemotherapy or radiotherapy.
- Patients must have performance status of >60%
- Patients must have a WBC count of >3.5, an ANC count >1500 and a platlet count of >100,000.
- The serum creatinine must be equal to or less than 1.5 m/dlor the calculated creatinine clearance must exceed 50cc/min.
- Patient must be free of significant infection or other severe complicating medical illness.
- Pregnancy will constitute an absolute contraindication to entrance on this protocol. Females of child-bearing age should be using adequate contraception.
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01693718
|The University of Chicago
|Chicago, Illinois, United States, 60653 |
University of Chicago
||Everett Vokes, MD
||The University of Chicago Medical Center
No publications provided
||University of Chicago
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 20, 2010
||September 4, 2013
||United States: Institutional Review Board
Keywords provided by University of Chicago:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 28, 2014
Head and Neck Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors