A Study of Chemoradiotherapy for Intermediate Stage/Selected Stage IV Cancers of the Head and Neck

NCT00203905 | Completed Phase 2 DMC

• 1 other identifier: 12652A
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to evaluate time to progression in eligible patients with cancer of the oral cavity, pharynx, larynx, paranasal sinuses, and cervical esophagus when treated with the concomitant chemoradiotherapy regimen of bevacizumab/5-fluorouracil (5-FU)/hydroxyurea/radiation therapy (B-FHX) in comparison to 5-fluorouracil hydroxyurea (FHX) alone.

Conditions

Head and Neck Cancer

Keywords

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• To evaluate the time to progression free survival in patients with cancer of the oral cavity, pharynx, larynx, paranasal sinuses, and cervical esophagus when treated with the concomitant chemoradiotherapy regimen

  From randomization until disease progression or death from any cause

Secondary Outcomes (1)

• To explore the pharmacodynamic changes induced on selected markers of angiogenesis by the addition of bevacizumab to FHX and compare them to those induced by FHX alone

  Baseline, week 2, and completion of therapy

Study Arms (2)

A

ACTIVE COMPARATOR

Hydroxyurea at 500 mg PO q 12 hours x 6 days (11 total doses); Infusion of 5-FU (600 mg/m2/day x 5 days \[120 hours\]

Drug: 5-Fluorouracil, Hydroxyurea-[FHX]

B

EXPERIMENTAL

Bevacizumab: 10 mg/kg will be given as a 90-minute infusion

Drug: 5-Fluorouracil, Hydroxyurea-[FHX], Bevacizumab

Interventions

5-Fluorouracil, Hydroxyurea-[FHX], Bevacizumab DRUG

Hydroxyurea at 500 mg PO q 12 hours x 6 days; Bevacizumab at 10 mg/kg as a 90-minute infusion; Infusion of 5-FU (600 mg/m2/day) X 5 days (120 hours)

B

5-Fluorouracil, Hydroxyurea-[FHX] DRUG

Hydroxyurea at 500 mg PO q 12 hours x 6 days; Infusion of 5-FU (600 mg/m2/day) X 5 days (120 hours)

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have stage II-III (carcinoma of head and neck, including oral cavity, pharynx, larynx, paranasal sinuses and cervical esophagus). Selected patients with stage disease (T will also be considered for enrolment). Therapy is given with curative intent. Patients with clinical N2 or N3 disease are excluded.
• 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 initial organ preserving surgery will be determined in each patient prior to therapy at the discretion of the treating surgeon. Salvage surgery and neck dissection will be allowed for suspicious or evident residual disease at the completion of the treatment regimen.
• Measurable disease is not required.
• Patients must have a histologically or cytologically confirmed diagnosis of carcinoma of the head and neck.
• No prior exposure to chemotherapy or radiotherapy for a malignancy of the head and neck.
• Patients must have ECOG performance status of 0-2.
• Age 18 years of age and older.
• Patients must have normal organ and bone marrow function.

You may not qualify if:

• Receiving any other investigational agents
• Recent (within 6 months) myocardial infarction, New York Heart Association (NYHA) - Class H or greater congestive heart failure, serious cardiac arrhythmia requiring medication, or Grade II or greater peripheral vascular disease within 1 year prior to treatment in the study
• Serious, non-healing wound, ulcer, or bone fracture.
• History of recurrent or chronic deep vein thrombosis or pulmonary embolus
• History of CNS disease (including CNS involvement from primary cancer) or hemorrhagic or thrombotic stroke within the last 6 months
• Uncontrolled hypertension
• Evidence of bleeding diathesis or coagulopathy
• History of hemoptysis
• Anatomic lesion that increases the risk of serious hemorrhage (e.g. invasion of a major vessel by tumor).
• History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.
• Current ongoing treatment with any dose of warfarin or its equivalent.
• Major surgical procedure or significant traumatic injury within 28 days prior to Day 0.
• Fine needle aspirations, indwelling catheter placement, or significant traumatic injury within 7 days prior to Day 0
• Anticipation of need for major surgical procedure during the course of the study.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to rhuMAb VEUF or other agents used in the study.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Fluorouracil; Bevacizumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Everett Vokes, M.D.

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: January 1, 2004
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2008
• Last Updated: January 17, 2014

Record last verified: 2014-01

Locations

US (1)