A Multicenter Study of Intensive Concomitant Chemoradiotherapy With Filgrastim (GCSF) for Patients With Locoregionally Advanced Head and Neck Cancer

Head and Neck Clinical Trial

Official title:

A Multicenter Phase II Study of Intensive Concomitant Chemoradiotherapy With Filgrastim (GCSF) for Patients With Locoregionally Advanced Head and Neck Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01693718
• Other study ID #: 12141B
• Status: Completed
• Phase: Phase 2
• Start date: March 2003
• Est. completion date: September 2004

Study information

• Verified date: January 2024
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of the study is to test a particular combination of drugs and determine their ability to completely eliminate head and neck cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: September 2004
• Est. primary completion date: September 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 59 Years and older

Eligibility

Eligibility Criteria:

1. 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.

2. Measurable disease is not required, but all disease will be carefully evaluated.

3. Patients must have a histologically or cytologically confirmed diagnosis of squamous cell carcinoma or lymphoepithelioma.

4. Patients must have not received prior chemotherapy or radiotherapy.

5. Patients must have performance status of >60%

6. Patients must have a WBC count of >3.5, an ANC count >1500 and a platlet count of >100,000.

7. The serum creatinine must be equal to or less than 1.5 m/dlor the calculated creatinine clearance must exceed 50cc/min.

8. Patient must be free of significant infection or other severe complicating medical illness.

9. Pregnancy will constitute an absolute contraindication to entrance on this protocol. Females of child-bearing age should be using adequate contraception.

Related Conditions & MeSH terms

• Head and Neck
• Head and Neck Neoplasms

Intervention

Drug:
• Hydroxyurea
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.
• 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
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.

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rates	To evaluate the activity of 5 cycles of C-FHX/G-CSF in previously untreated patients with stage II and IV locoregionally advanced head and neck cancer.	2-5 years
Secondary	Feasibility of administering adjuvant CRA and interferon alfa2a	To determine the feasibility of administering adjuvant CRA and interferon alfa2a for up to one or until tumor progression in patients completing local therapy.	2-5 years
Secondary	Side effects of study regimen	To determine the pattern and degree of clinical toxicity of this regimen	2-5 years