S0618 E7389 in Treating Patients With Metastatic or Recurrent Head and Neck Cancer - Full Text View

Purpose

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.

Condition	Intervention	Phase
Head and Neck Cancer	Drug: eribulin mesylate	Phase 2

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Evaluation of E7389 (NSC-707389) in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Eribulin Eribulin mesylate

U.S. FDA Resources

Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Progression-Free Survival [ Time Frame: Every 6 weeks until progression of disease up to a maximum of 3 years after registration. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
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.
Toxicity [ Time Frame: Every 3 weeks while on protocol therapy ] [ Designated as safety issue: Yes ]
The NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0 was utilized.

Enrollment:	42
Study Start Date:	May 2006
Study Completion Date:	January 2010
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: eribulin mesylate eribulin mesylate	Drug: eribulin mesylate 1.4 mg/m2 by IV bolus on Days 1 and 8 of an every 21-day cycle. Other Name: E7389

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00337129

Show 139 Study Locations

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Susanne M. Arnold, MD

Lucille P. Markey Cancer Center at University of Kentucky

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Southwest Oncology Group
ClinicalTrials.gov Identifier:	NCT00337129 History of Changes
Other Study ID Numbers:	CDR0000481530, U10CA032102, S0618
Study First Received:	June 13, 2006
Results First Received:	July 20, 2012
Last Updated:	July 20, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Southwest Oncology Group:

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

Additional relevant MeSH terms:

Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site

ClinicalTrials.gov processed this record on May 19, 2013