Stage IVA Cervical Cancer Clinical Trial
Official title:
Phase II Clinical Trial of Eribulin in Advanced or Recurrent Cervical Cancer
Verified date | November 2021 |
Source | University of Southern California |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 32 |
Est. completion date | August 9, 2021 |
Est. primary completion date | February 21, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | USC Norris Comprehensive Cancer Center | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of Southern California | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free survival | Product limits estimates of 6-month PFS will be computed using all patients enrolled on the study. 95% confidence intervals will be based on Greenwood standard errors. | From the first day of treatment to the first observation of disease progression or death due to any cause, assessed at 6 months | |
Primary | Number of participants with serious adverse events (SAEs) | The rate of grade 3+ hematologic and non-hematologic toxicities will be computed for course 1 and for all courses combined. Safety evaluation according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.3. | Up to 2 years | |
Secondary | Best overall response (BOR) | Exact 95% binomial confidence intervals will be computed for the BOR rate. BOR defined as the best response recorded from the start of treatment until disease progression/recurrence, evaluated according to RECIST 1.1. | Up to 2 years | |
Secondary | Overall survival (OS) | From first day of treatment to time of death due to any cause, assessed up to 2 years |
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