Phase II Study of Clinical Activity of Pegaspargase in Women With Relapsed or Refractory Epithelial Ovarian Cancer, Fallopian Tube Cancer, and/or Primary Peritoneal Cancer
Public ClinicalTrials.gov record NCT01313078. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Background: \- The best treatment for ovarian and related female reproductive tract cancers is not yet known for patients whose disease has not responded to or has recurred after standard treatment. The cancer treatment drug pegaspargase (ONCASPAR (Trademark)), which works differently from standard chemotherapy, has been approved to treat leukemia and has been given to a small number of patient with ovarian and other types of cancer. Because pegaspargase may reduce the development of cancer cells and blood vessel cells that contribute to cancer growth and ability to spread, treatment with pegaspargase could shrink ovarian cancer tumors and help ovarian cancer patients live longer and with fewer symptoms from their disease. Objectives: \- To evaluate the safety and effectiveness of pegaspargase in patients with recurrent or refractory ovarian cancer, fallopian tube cancer, and/or primary peritoneal cancer. Eligibility: \- Women at least 18 years of age who have been diagnosed with epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that has not responded to at least one operation, chemotherapy, and/or radiotherapy. Design: * Before the start of the study, participants will be screened with a medical history, blood tests, imaging scans of the affected areas, tumor biopsies, and other tests as directed by the study doctors. * Participants will receive an infusion of pegaspargase on Day 1 and Day 15 of each 28-day cycle. * Participants will have dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) at the start of the study, before beginning pegaspargase, and again 6 weeks into the treatment. This test will determine if pegaspargase is affecting blood flow to the cancer site. * Participants will have a computed tomography scan or other imaging every other cycle (approximately every 8 weeks) to determine whether the therapy is affecting the cancer site. * The treatment will be repeated as long as the participant tolerates the medication and his or her cancer is either steady or improving.
Study identification
- NCT ID
- NCT01313078
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 4 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2009
- Primary completion
- Aug 31, 2011
- Completion
- Aug 31, 2011
- Last update posted
- Oct 8, 2015
2010 – 2011
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01313078, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 8, 2015 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01313078 live on ClinicalTrials.gov.