Know Cancer

forgot password

A Phase 1, Open-Label, Dose Escalation Study of the Safety and Preliminary Efficacy of EGEN-001 in Combination With Carboplatin and Docetaxel in Women With Recurrent, Platinum-Sensitive, Epithelial Ovarian Cancer

Phase 1
18 Years
Not Enrolling
Ovarian Neoplasms

Thank you

Trial Information

A Phase 1, Open-Label, Dose Escalation Study of the Safety and Preliminary Efficacy of EGEN-001 in Combination With Carboplatin and Docetaxel in Women With Recurrent, Platinum-Sensitive, Epithelial Ovarian Cancer

This study has two purposes:

- To determine what different strengths and number of doses of EGEN-001, administered
directly into the peritoneal cavity, can be given safely in combination with standard
intravenous chemotherapy for ovarian cancer

- To evaluate the anti-cancer activity of EGEN-001 when combined with standard
chemotherapy; biological markers of EGEN-001 activity will be collected and ovarian
cancer burden will be evaluated per standard practice.

Inclusion Criteria:

- Be female and at least 18 years of age (or minimum legal age and competency to
provide voluntary written informed consent for study participation);

- Histologically/cytologically confirmed epithelial ovarian cancer that meets one of
the following criteria:

- measurable disease by computed tomography (CT) scan or

- malignant ascites, or

- Serum CA-125 levels; or

- Clinically evaluable recurrent disease by other criteria.

- Relapsed, platinum-sensitive, ovarian cancer after induction chemotherapy (at least 6
months since last exposure to platinum based therapy).

- Eastern Cooperative Oncology Group (ECOG) Performance score of 0, 1 or 2;

- Recovered from prior chemotherapy, having adequate bone marrow function:

- Adequate renal function;

- Adequate liver function;

- If of childbearing potential, have a negative pregnancy test and agree to follow an
acceptable method of birth control;

- Agree to be compliant with the study's requirements;

- Understand and sign a written Informed Consent prior to the performance of any
study-related procedures.

Exclusion Criteria:

- Ovarian cancer other than documented epithelial cancer;

- Intra-abdominal disease > 5 cm in diameter;

- Any serious, uncontrolled, intercurrent medical illness or disorder including, but
not limited to:

- Autoimmune disorders

- Cardiac Disorders

- Diabetes

- Intrahepatic disease/cancer as documented by CT-scan

- An active infection within 4 weeks of study entry;

- Any condition/anomaly that would interfere with the appropriate placement of the IP
catheter for study drug administration

- Prior treatment with whole abdominal irradiation;

- Currently receiving or have received any investigational agents within 28 days of
study entry;

- Received prior chemotherapy for ovarian cancer administered by the IP route;

- Received any chemotherapy between completion of primary chemotherapy for ovarian
cancer and study entry (e.g. consolidation therapy);

- Receipt of immunotherapy and/or any medications with the potential to affect the
activity of EGEN 001;

- Known history of HIV infection, hepatitis B, or hepatitis C;

- Known hypersensitivity to any of the components of carboplatin or docetaxel;

- Life expectancy of less than 3 months;

- Known, current, recreational drug or alcohol abuse;

- Breast feeding an infant;

- Psychiatric illness/social situations which would limit compliance with study

- Any other known condition which in the Investigator's opinion would make the patient
a poor candidate for the study.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the MTD and treatment-related toxicities of intra-peritoneal (IP) infusion of EGEN-001 in combination with carboplatin and docetaxel for recurrent, platinum-sensitive, ovarian cancer.

Outcome Time Frame:

12-14 months

Safety Issue:


Principal Investigator

Ronald D. Alvarez, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Division of Gynecologic Oncology at University of Alabama at Birmingham


United States: Food and Drug Administration

Study ID:




Start Date:

April 2007

Completion Date:

November 2009

Related Keywords:

  • Ovarian Neoplasms
  • Neoplasms
  • Ovarian Neoplasms



Baylor College of Medicine Houston, Texas  77030
University of Alabama at Birmingham Birmingham, Alabama  35294-3300
University of Pennsylvania Philadelphia, Pennsylvania  19104
Oncology Specialties, PC Huntsville, Alabama  35805