Phase II Evaluation of E7389 (NSC-707389) in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 42
- Locations
- 138
- Primary Endpoint
- Response Probability (Confirmed Complete and Partial Responses)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
eribulin mesylate
eribulin mesylate
Intervention: eribulin mesylate (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Overall Survival(Every 3 months for first year, then every six months thereafter up to a maximum of 3 years from registration.)
- Participants With a Given Type of AE(Every 3 weeks while on protocol therapy, up to 3 years.)
- Progression-Free Survival(Every 6 weeks until progression of disease up to a maximum of 3 years after registration.)