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| Sponsor: | Gynecologic Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00939809 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Biological: A6 Other: laboratory biomarker analysis |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| 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 |
| Estimated Enrollment: | 50 |
| Study Start Date: | August 2009 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
Tertiary
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed persistent or recurrent ovarian epithelial, fallopian tube, or primary peritoneal carcinoma, including any of the following epithelial cell types:
Must have ≥ 1 target lesion to assess response as defined by RECIST criteria
Must have received 1 prior platinum-based chemotherapeutic regimen containing carboplatin, cisplatin, or another organoplatinum compound for management of primary disease
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No prior non-cytotoxic therapy for management of recurrent or persistent disease
More than 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin AND remains free of recurrent or metastatic disease
Contacts and Locations
Show 24 Study Locations| Study Chair: | Michael A. Gold, MD | Vanderbilt Medical Group & Clinic at Vanderbilt Medical Center |
More Information
| Responsible Party: | Angstrom Pharmaceuticals, Incorporated ( Responsible Party ) |
| Study ID Numbers: | CDR0000644399, GOG-0170N |
| Study First Received: | July 14, 2009 |
| Last Updated: | January 28, 2010 |
| ClinicalTrials.gov Identifier: | NCT00939809 History of Changes |
| Health Authority: | United States: Federal Government |
|
ovarian clear cell cystadenocarcinoma ovarian endometrioid adenocarcinoma ovarian mixed epithelial carcinoma ovarian mucinous cystadenocarcinoma ovarian serous cystadenocarcinoma |
ovarian undifferentiated adenocarcinoma recurrent ovarian epithelial cancer Brenner tumor fallopian tube cancer peritoneal cavity cancer |
|
Digestive System Neoplasms Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Abdominal Neoplasms Fallopian Tube Neoplasms |
Fallopian Tube Diseases Adnexal Diseases Genital Diseases, Female Neoplasms Digestive System Diseases Neoplasms by Site Peritoneal Diseases Peritoneal Neoplasms Endocrine Gland Neoplasms |