Phase II Evaluation of E7389 (NSC-707389) in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck
Phase II Evaluation of E7389 (NSC-707389) in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck
RATIONALE: Drugs used in chemotherapy, such as E7389, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well E7389 works in treating patients with metastatic or recurrent head and neck cancer.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive E7389 IV on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
After completion of study treatment, patients are followed periodically for up to 3 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (SCCHN)
Measurable disease
No active or prior CNS metastasis
PATIENT CHARACTERISTICS:
Zubrod performance status 0-1
Absolute granulocyte count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Bilirubin ≤ 2 times upper limit of normal (ULN)
SGOT and SGPT ≤ 2 times ULN
Creatinine ≤ 2 times ULN
Not pregnant or nursing
Fertile patients must use effective contraception
No known HIV positivity
No prior malignancies except for the following:
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
No prior chemotherapy for recurrent or newly diagnosed metastatic disease
At least 6 months since prior induction or adjuvant chemotherapy for patients who relapsed after receiving this therapy
More than 2 weeks since prior biologic therapy (i.e., epidermal growth factor inhibitors and vascular endothelial growth factor inhibitors)
More than 28 days since prior radiotherapy and recovered
More than 28 days since prior surgery and recovered
No other concurrent therapy (i.e., radiotherapy, chemotherapy, immunotherapy, biologic therapy, or gene therapy) for SCCHN
No concurrent combination antiretroviral therapy for HIV-positive patients
No concurrent prophylactic colony-stimulating factors during course 1
Little Rock, Arkansas 72205, United States
Orange, California 92868, United States
Valdosta, Georgia 31603, United States
Beech Grove, Indiana 46107, United States
Wichita, Kansas 67214, United States
Lexington, Kentucky 40536-0093, United States
Dearborn, Michigan 48123-2500, United States
Grosse Pointe Woods, Michigan 48236, United States
Billings, Montana 59101, United States
Missoula, Montana 59807, United States
Middletown, New York 10940-4199, United States
Rochester, New York 14642, United States
Portland, Oregon 97210, United States
Portland, Oregon 97213-2967, United States
Portland, Oregon 97227, United States
Spartanburg, South Carolina 29303, United States
Knoxville, Tennessee 37920-6999, United States
Murray, Utah 84157, United States
Martinsville, Virginia 24115, United States
Seattle, Washington 98122-4307, United States
Seattle, Washington 98195-6043, United States