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

Primary Purpose

Head and Neck

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Hydroxyurea

5- Fluorouracil

Cisplatin

About this trial

This is an interventional treatment trial for Head and Neck focused on measuring cancer, advanced, oral cavity, larynx

Eligibility Criteria

59 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Eligibility Criteria:

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.

Sites / Locations

The University of Chicago

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Side effects of study regimen

To determine the pattern and degree of clinical toxicity of this regimen

Full Information

NCT ID

NCT01693718

First Posted

August 20, 2010

Last Updated

September 4, 2013

Sponsor

University of Chicago

1. Study Identification

Unique Protocol Identification Number

NCT01693718

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Completed

Study Start Date

March 2003 (undefined)

Primary Completion Date

September 2003 (Actual)

Study Completion Date

September 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Chicago

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck

Keywords

cancer, advanced, oral cavity, larynx

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Hydroxyurea

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

5- Fluorouracil

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

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.

Primary Outcome Measure Information:

Title

Response Rates

Description

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.

Time Frame

2-5 years

Secondary Outcome Measure Information:

Title

Feasibility of administering adjuvant CRA and interferon alfa2a

Description

To determine the feasibility of administering adjuvant CRA and interferon alfa2a for up to one or until tumor progression in patients completing local therapy.

Time Frame

2-5 years

Title

Side effects of study regimen

Description

To determine the pattern and degree of clinical toxicity of this regimen

Time Frame

2-5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

59 Years

Accepts Healthy Volunteers

Eligibility Criteria

Eligibility Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Everett Vokes, MD

Organizational Affiliation

The University of Chicago Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

The University of Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60653

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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