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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Everett Vokes, University of Chicago
ClinicalTrials.gov Identifier:
NCT01693718
First received: August 20, 2010
Last updated: September 24, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Intervention Phase
Head and Neck
 Drug: Hydroxyurea
Drug: 5- Fluorouracil
Drug: Cisplatin
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Response Rates [ Time Frame: 2-5 years ] [ Designated as safety issue: No ]
    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 [ 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


Enrollment: 44
Study Start Date: March 2003
Study Completion Date: September 2004
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   59 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01693718

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

No publications provided

Responsible Party: Everett Vokes, Department Chair, Professor, University of Chicago
ClinicalTrials.gov Identifier: NCT01693718     History of Changes
Other Study ID Numbers: 12141B
Study First Received: August 20, 2010
Last Updated: September 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
cancer
advanced
oral cavity
larynx

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Cisplatin
Fluorouracil
Hydroxyurea
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
 Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Antisickling Agents
Hematologic Agents
Enzyme Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on June 17, 2013