A6 in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
RATIONALE: A6 may stop the growth of tumor cells by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying the side effects and how well A6 works in treating patients with persistent or recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
Fallopian Tube Cancer
Primary Peritoneal Cavity Cancer
Biological: urokinase-derived peptide A6
Other: laboratory biomarker analysis
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- 6-month progression-free survival rate [ Designated as safety issue: No ]
- Objective tumor response (complete or partial) rate [ Designated as safety issue: No ]
- Frequency and severity of adverse events as assessed by CTCAE v3.0 [ Designated as safety issue: Yes ]
- Duration of progression-free survival and overall survival [ Designated as safety issue: No ]
|Study Start Date:||August 2009|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
- 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.
- To characterize the duration of PFS and overall survival.
- To identify biomarkers of drug effect on peripheral blood mononuclear cells (PBMCs).
- 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.
Hide Study Locations
|United States, Georgia|
|MBCCOP - Medical College of Georgia Cancer Center|
|Augusta, Georgia, United States, 30912|
|United States, Illinois|
|Hinsdale Hematology Oncology Associates|
|Hinsdale, Illinois, United States, 60521|
|United States, Iowa|
|Holden Comprehensive Cancer Center at University of Iowa|
|Iowa City, Iowa, United States, 52242-1002|
|United States, Michigan|
|West Michigan Cancer Center|
|Kalamazoo, Michigan, United States, 49007-3731|
|United States, Mississippi|
|Regional Cancer Center at Singing River Hospital|
|Pascagoula, Mississippi, United States, 39581|
|United States, Nebraska|
|Methodist Estabrook Cancer Center|
|Omaha, Nebraska, United States, 68114|
|United States, New Jersey|
|Cancer Institute of New Jersey at Cooper - Voorhees|
|Voorhees, New Jersey, United States, 08043|
|United States, New York|
|Stony Brook University Cancer Center|
|Stony Brook, New York, United States, 11794-9446|
|United States, Ohio|
|Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Cleveland Clinic Cancer Center at Fairview Hospital|
|Cleveland, Ohio, United States, 44111|
|Cleveland Clinic Taussig Cancer Center|
|Cleveland, Ohio, United States, 44195|
|MetroHealth Cancer Care Center at MetroHealth Medical Center|
|Cleveland, Ohio, United States, 44109|
|Riverside Methodist Hospital Cancer Care|
|Columbus, Ohio, United States, 43214-3998|
|Hillcrest Cancer Center at Hillcrest Hospital|
|Mayfield Heights, Ohio, United States, 44124|
|United States, Oklahoma|
|Oklahoma University Cancer Institute|
|Oklahoma City, Oklahoma, United States, 73104|
|United States, Pennsylvania|
|Rosenfeld Cancer Center at Abington Memorial Hospital|
|Abington, Pennsylvania, United States, 19001|
|UPMC Cancer Center at Magee-Womens Hospital|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Rhode Island|
|Women and Infants Hospital of Rhode Island|
|Providence, Rhode Island, United States, 02905|
|United States, South Dakota|
|Black Hills Obstetrics & Gynecology LLP|
|Rapid City, South Dakota, United States, 57701|
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|United States, Utah|
|Huntsman Cancer Institute at University of Utah|
|Salt Lake City, Utah, United States, 84112|
|United States, Vermont|
|Fletcher Allen Health Care - University Health Center Campus|
|Burlington, Vermont, United States, 05401|
|United States, Wisconsin|
|St. Vincent Hospital Regional Cancer Center|
|Green Bay, Wisconsin, United States, 54307-3508|
|Gundersen Lutheran Center for Cancer and Blood|
|La Crosse, Wisconsin, United States, 54601|
|Study Chair:||Michael A. Gold, MD||Vanderbilt Medical Group & Clinic at Vanderbilt Medical Center|