S0618 E7389 in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
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.
|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|
- 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.
- 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.
|Study Start Date:||May 2006|
|Study Completion Date:||January 2010|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
Experimental: 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
- 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.