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

Phase 2

Completed

Brief 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.

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
eribulin mesylate	eribulin mesylate	eribulin mesylate

Primary Outcome Measures

Name	Time	Method
Response Probability (Confirmed Complete and Partial Responses)	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.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	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	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.
Progression-Free Survival	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.

Locations (138): Alaska Regional Hospital Cancer Center
🇺🇸
Anchorage, Alaska, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸
Little Rock, Arkansas, United States
Providence Saint Joseph Medical Center - Burbank
🇺🇸
Burbank, California, United States
City of Hope Comprehensive Cancer Center
🇺🇸
Duarte, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
🇺🇸
Orange, California, United States
Broward General Medical Center Cancer Center
🇺🇸
Fort Lauderdale, Florida, United States
M.D. Anderson Cancer Center at Orlando
🇺🇸
Orlando, Florida, United States
Northeast Georgia Medical Center
🇺🇸
Gainesville, Georgia, United States
Pearlman Comprehensive Cancer Center at South Georgia Medical Center
🇺🇸
Valdosta, Georgia, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
🇺🇸
Beech Grove, Indiana, United States
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Alaska Regional Hospital Cancer Center
🇺🇸Anchorage, Alaska, United States