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

National Cancer Institute (NCI)

Status and phase

Completed

Phase 2

Conditions

Head and Neck Cancer

Treatments

Drug: eribulin mesylate

Study type

Interventional

Funder types

NIH

Identifiers

NCT00337129

S0618 (Other Identifier)

NCI-2012-03046

CDR0000481530 (Registry Identifier)

U10CA032102 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

Evaluate the response probability (confirmed, complete, and partial responses) in patients with metastatic or recurrent squamous cell carcinoma of the head and neck treated with E7389.
Estimate progression-free and overall survival probability in these patients.
Evaluate the qualitative and quantitative toxicities of this treatment regimen.

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.

Enrollment

42 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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