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Phase II Evaluation of E7389 (NSC-707389) in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck

Phase 2
18 Years
Not Enrolling
Head and Neck Cancer

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Trial Information

Phase II Evaluation of E7389 (NSC-707389) in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck


- 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.

Inclusion Criteria


- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Probability (Confirmed Complete and Partial Responses)

Outcome Description:

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.

Outcome Time Frame:

Every 6 weeks until progression of disease up to a maximum of 3 years after registration

Safety Issue:


Principal Investigator

Susanne M. Arnold, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Lucille P. Markey Cancer Center at University of Kentucky


United States: Food and Drug Administration

Study ID:




Start Date:

May 2006

Completion Date:

January 2010

Related Keywords:

  • Head and Neck Cancer
  • metastatic squamous neck cancer with occult primary squamous cell carcinoma
  • recurrent metastatic squamous neck cancer with occult primary
  • recurrent squamous cell carcinoma of the hypopharynx
  • recurrent squamous cell carcinoma of the larynx
  • recurrent squamous cell carcinoma of the lip and oral cavity
  • recurrent squamous cell carcinoma of the oropharynx
  • recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage IV squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
  • untreated metastatic squamous neck cancer with occult primary
  • salivary gland squamous cell carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms



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