Phase II Clinical Trial of Eribulin in Advanced or Recurrent Cervical Cancer
DescriptionPRIMARY OBJECTIVES: I. To evaluate the activity of eribulin (eribulin mesylate) in the management of advanced or recurrent cervical cancer (progression-free survival [PFS]. SECONDARY OBJECTIVES: I. To describe the toxicity profile of eribulin in patients with advanced or recurrent cervical cancer. II. To estimate the survival of patients with advanced or recurrent cervical cancer treated with eribulin. III. To evaluate potential correlative studies as predictive or prognostic makers in this patient population (glucose-regulated protein 78 [GRP78] levels in tissue and blood, tumor protein p53 [p53] expression, apoptosis with terminal deoxynucleotidyl transferase dUTP nick end labeling [TUNEL] assay, apoptosis-related proteins B-cell lymphoma 2 [Bcl-2] and Bcl2-associated X protein [Bax] using immunohistochemistry [IHC], proliferation with Ki-67 IHC, and expression levels of microtubule-associated variables, including tau protein, total alpha- and beta-tubulin, and classes II-IV beta-tubulin isotopes with IHC. OUTLINE: Patients receive eribulin mesylate 1.4 mg/m2 intravenously (IV) bolus over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years.
PhasePhase 2 - takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn't usually preclude the patient from getting the standard treatment after they've received the investigational agent. At best they are allowed to get a new drug they wouldn't be able to get otherwise that may turn out to be better for their disease.
Inclusion and Exclusion 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
- 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
Please contact Gangothri Namasivayam to learn more about where you can participate in this trial. Please use the contact form on the right side.