Overview

Eribulin Mesylate in Treating Patients With Advanced or Recurrent Cervical Cancer

Status:
Unknown status
Trial end date:
2021-08-09
Target enrollment:
0
Participant gender:
Female
Summary
This phase II trial studies how well eribulin mesylate works in treating patients with advanced or recurrent cervical cancer. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Southern California
Collaborator:
National Cancer Institute (NCI)
Criteria
Inclusion Criteria:

- Histologically confirmed diagnosis of invasive cervical cancer

- Measurable disease

- 0-1 prior chemotherapy regimens for recurrent or advanced disease; platinum based
chemotherapy administered as a radiation sensitizer agent is allowed and does not
count as prior therapy

- Absolute granulocyte count (AGC) >= 1,500

- Platelet >= 100,000

- Serum creatinine < 2.0 mg/dl

- Bilirubin =< 1.5 times the upper limit of the normal range (ULN)

- Alkaline phosphatase =< 3 x ULN (in the case of liver metastases, =< 5 x ULN)

- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN (in the
case of liver metastases, =< 5 x ULN)

- Peripheral neuropathy grade 0-2

- Recovery of all chemotherapy or radiation-related toxicities to grade =< 1, except for
alopecia and peripheral neuropathy

- Performance status 0-2

- Signed informed consent

Exclusion Criteria:

- Prior treatment with eribulin

- Chemotherapy, radiation, or biological or targeted therapy within 3 weeks

- Hormonal therapy within 1 week

- Any investigational drug within 4 weeks

- Known brain metastases, unless previously treated and asymptomatic for 3 months and
not progressive in size or number for 3 months