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

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (SCCHN)

• Disease is either metastatic at diagnosis or has persisted, metastasized, or recurred after definitive surgery and/or radiotherapy

• Not amenable to surgical resection for salvage therapy

• No newly diagnosed nonmetastatic disease

• No salivary or nasopharyngeal primary disease

• Patients who have failed primary surgery alone, and who have disease that is salvageable by radiation or chemoradiation, are not eligible

• 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