S0618 E7389 in Treating Patients With Metastatic or Recurrent Head and Neck Cancer

Exclusion Criteria

• •Measurable disease
• •* Measurable disease within a previous radiotherapy port must demonstrate clearly progressive 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:
• •* Adequately treated basal cell or squamous cell skin cancer
• •* In situ cervical cancer
• •* Adequately treated stage I or II cancer currently in complete remission
• •* Any other cancer for which the patient has been disease free for ≥ 5 years
• •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
• •* No more than 1 prior induction or adjuvant regimen (may have included a taxane)
• •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