A Phase II Evaluation of a Urokinase-Derived Peptide (A6) (IND #64,298) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
OBJECTIVES:
Primary
- To assess the activity of A6, as measured by the 6-month progression-free survival
(PFS) rate and objective tumor response (complete or partial) rate, in patients with
persistent or recurrent ovarian epithelial, fallopian tube, or primary peritoneal
carcinoma.
- To determine the frequency and severity of adverse events as assessed by CTCAE v3.0.
Secondary
- To characterize the duration of PFS and overall survival.
- To identify biomarkers of drug effect on peripheral blood mononuclear cells (PBMCs).
Tertiary
- To explore whether genes identified as being up- or down-regulated by exposure of human
PBMCs to A6 in vitro are also up- or down-regulated following treatment of patients
with A6 in vivo.
- To explore whether there is an association between the expression of candidate A6
receptors in the tumor prior to treatment with A6 (as determined by IHC) and response
and PFS.
- To explore whether there is an association between change in expression of candidate
biomarkers in PBMCs between 0-24 hours following the first dose of A6 and response and
PFS.
- To explore whether there is an association between change in expression of candidate
biomarkers in PBMCs over the course of the first one month cycle (course 1) and
response and PFS.
- To determine whether there is an association between plasma A6 levels measured on days
2 (24 hours after the first dose and 4 hours after the second dose) and 8 (prior to
injection of A6) of course 1 and levels of expression of candidate biomarkers in PBMCs
collected on the same days.
- To explore whether there is an association between plasma A6 levels measured on days 2
(24 hours after the first dose and 4 hours after the second dose) and 8 (prior to
injection of A6) of course 1 and response and PFS.
- To explore whether there is an association between candidate serum biomarkers and
response and PFS over the course of A6 treatment.
OUTLINE: This is a multicenter study.
Patients receive A6 subcutaneously once daily on days 1-28. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 3 years.
Interventional
Masking: Open Label, Primary Purpose: Treatment
6-month progression-free survival rate
No
Michael A. Gold, MD
Study Chair
Vanderbilt Medical Group & Clinic at Vanderbilt Medical Center
United States: Federal Government
CDR0000644399
NCT00939809
August 2009
Name | Location |
---|---|
Hinsdale Hematology Oncology Associates | Hinsdale, Illinois 60521 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
MetroHealth Cancer Care Center at MetroHealth Medical Center | Cleveland, Ohio 44109 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
UPMC Cancer Center at Magee-Womens Hospital | Pittsburgh, Pennsylvania 15213-3180 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
Fletcher Allen Health Care - University Health Center Campus | Burlington, Vermont 05401 |
Women and Infants Hospital of Rhode Island | Providence, Rhode Island 02905 |
Stony Brook University Cancer Center | Stony Brook, New York 11794-8174 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
MBCCOP - Medical College of Georgia Cancer Center | Augusta, Georgia 30912-3730 |
Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
Gundersen Lutheran Center for Cancer and Blood | La Crosse, Wisconsin 54601 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
Huntsman Cancer Institute at University of Utah | Salt Lake City, Utah 84112 |
Cleveland Clinic Cancer Center at Fairview Hospital | Cleveland, Ohio 44111 |
Hillcrest Cancer Center at Hillcrest Hospital | Mayfield Heights, Ohio 44124 |
Rosenfeld Cancer Center at Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
Regional Cancer Center at Singing River Hospital | Pascagoula, Mississippi 39581 |
Black Hills Obstetrics & Gynecology LLP | Rapid City, South Dakota 57701 |