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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01693718
Recruitment Status : Completed
First Posted : September 26, 2012
Last Update Posted : September 5, 2013
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment Phase
Head and Neck Drug: Hydroxyurea Drug: 5- Fluorouracil Drug: Cisplatin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Phase II Study of Intensive Concomitant Chemoradiotherapy With Filgrastim (GCSF) for Patients With Locoregionally Advanced Head and Neck Cancer
Study Start Date : March 2003
Actual Primary Completion Date : September 2003
Actual Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Filgrastim
U.S. FDA Resources

Intervention Details:
    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.
    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.

    Drug: 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.

Primary Outcome Measures :
  1. Response Rates [ Time Frame: 2-5 years ]
    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 :
  1. Feasibility of administering adjuvant CRA and interferon alfa2a [ Time Frame: 2-5 years ]
    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. Side effects of study regimen [ Time Frame: 2-5 years ]
    To determine the pattern and degree of clinical toxicity of this regimen

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Ages Eligible for Study:   59 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01693718

United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60653
Sponsors and Collaborators
University of Chicago
Principal Investigator: Everett Vokes, MD The University of Chicago Medical Center

Responsible Party: University of Chicago Identifier: NCT01693718     History of Changes
Other Study ID Numbers: 12141B
First Posted: September 26, 2012    Key Record Dates
Last Update Posted: September 5, 2013
Last Verified: September 2013

Keywords provided by University of Chicago:
oral cavity

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Antisickling Agents
Enzyme Inhibitors
Nucleic Acid Synthesis Inhibitors