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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00337129
Recruitment Status : Completed
First Posted : June 15, 2006
Results First Posted : August 29, 2012
Last Update Posted : August 25, 2015
Information provided by (Responsible Party):
National Cancer Institute (NCI)

June 13, 2006
June 15, 2006
July 20, 2012
August 29, 2012
August 25, 2015
May 2006
August 2008   (Final data collection date for primary outcome measure)
Response Probability (Confirmed Complete and Partial Responses) [ Time Frame: Every 6 weeks until progression of disease up to a maximum of 3 years after registration ]
Response was defined per RECIST. Complete response (CR) was defined as complete disappearance of all baseline measurable and non-measurable disease with no new lesions. Partial response (PR) was defined as at least 30% decrease under baseline of the sum of longest diameters of all target measurable lesions with no unequivocal progression of non-measurable disease and no new lesions. A CR or PR must be confirmed by a second determination at least 4 weeks apart. All disease must have been assessed using the same technique as baseline.
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Complete list of historical versions of study NCT00337129 on Archive Site
  • Progression-Free Survival [ Time Frame: Every 6 weeks until progression of disease up to a maximum of 3 years after registration. ]
    Progression-free survival was defined as the time from date of registration to the date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at date of last contact.
  • Overall Survival [ Time Frame: Every 3 months for first year, then every six months thereafter up to a maximum of 3 years from registration. ]
    Overall survival was defined as the time from the date of registration to the date of death due to any cause. Patients last known to be alive are censored at date of last contact.
  • Participants With a Given Type of AE [ Time Frame: Every 3 weeks while on protocol therapy, up to 3 years. ]
    The NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0 was utilized.
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S0618 E7389 in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
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.


  • 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.

Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Head and Neck Cancer
Drug: eribulin mesylate
1.4 mg/m2 by IV bolus on Days 1 and 8 of an every 21-day cycle.
Other Name: E7389
Experimental: eribulin mesylate
eribulin mesylate
Intervention: Drug: eribulin mesylate
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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July 2011
August 2008   (Final data collection date for primary outcome measure)


  • 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


  • 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


  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
U10CA032102 ( U.S. NIH Grant/Contract )
S0618 ( Other Identifier: SWOG )
CDR0000481530 ( Registry Identifier: PDQ (Physician Data Query) )
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National Cancer Institute (NCI)
National Cancer Institute (NCI)
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Study Chair: Susanne M. Arnold, MD Lucille P. Markey Cancer Center at University of Kentucky
National Cancer Institute (NCI)
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP