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5C-11-2 Phase II Clinical Trial of Eribulin in Advanced or Recurrent Cervical Cancer

Description

Cervical cancer is the second most common cancer in women worldwide; and, in developing countries, it is the leading cause of death by cancer. Treatment for advanced disease after the use of platinum based therapy yields low response and survival rates, therefore there is a huge need for the identification of active agents.. Eribulin is a targeted agent that inhibits cell growth in multiple types of cancers. Previous studies have shown that it improves response and survival rates. This study is a phase II, single arm, two-stage study using eribulin in patients with advanced cervical cancer. The primary objective of this study is to evaluate the effectiveness of eribulin in these patients.Patients with laboratory confirmed invasive cervical cancer who have had up to 1 previous chemotherapy regimen for advanced disease will be considered for this study. Once patients have agreed to participate, they will be screened for eligibility. Once they are deemed eligible, they will receive eribulin through a vein in the arm on Days 1 and 8 of a 21-day treatment cycle. They will have a study visits during each cycle that will include the following tests and procedures: blood tests, physical exams, vital signs, ECG to check their heart, evaluation of their ability to carry out everyday activities, and an evaluation of side effects. They will also have x-rays or CT/MRI scans to determine whether their tumor is growing. Tumor tissue from a previous biopsy or surgery and blood samples will be collected for research testing. Subjects will continue taking the study drug until their tumor grows or they have unacceptable side effects.Fifteeen patients will be treated and evaluated in the first stage; if 1 or more of the 15 patients achieves a progression free survival of 6 months, an additional 15 patients will be accrued into the second stage.The primary efficacy endpoint will be 6-month progression-free survival. The secondary efficacy endpoint will be best overall response. The occurrence of toxic death (TD) at any time will be a primary endpoint for safety monitoring. The study will be terminated if fewer than 1 out of 15 patients are progression-free at 6 months.

Phase

Phase 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

Sites

Please contact Gangothri Namasivayam to learn more about where you can participate in this trial. Please use the contact form on the right side.

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