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
Completed · Phase 2
Conditions studied: Ovarian Neoplasms, Fallopian Tube Neoplasms, Primary Peritoneal Neoplasms
In brief
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.
Key facts
- Study ID
- NCT01313078
- Run by
- National Cancer Institute (NCI)
- People needed
- 4
- Starts
- 2010-01-01
- Expected to finish
- 2011-09-01
- Last updated by the study team
- 2015-10-09
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may not qualify if…
- Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the Investigator's opinion makes it unsafe for the patient to participate in the trial or which would jeopardize compliance with the protocol.
- Evidence of central nervous system (CNS) involvement. Patients with abnormal clinical exam or history will require a head computed tomography (CT) or magnetic resonance imaging (MRI).
- History of clinically symptomatic pancreatitis within the six months prior to enrollment.
- History of prior exposure to any formulation of L-asparaginase.
- Patients with a history of deep venous thrombosis or pulmonary embolism within the past 3 months, or pulmonary embolism within the past 6 months, history of recurrent clot or pulmonary embolism (PE), or those patients requiring ongoing full dose anticoagulation will be ineligible. Line prophylaxis with 1 mg warfarin daily will be allowed.
- Patients with active infection will not be eligible, but may become eligible once infection has resolved and they are at least 7 days from completion of antibiotics.
- Women who are pregnant and women actively breast-feeding will be excluded.
- Previous or current malignancies within the last 5 years, with the exception of cervical carcinoma in situ curatively treated, ductal or lobular carcinoma in situ curatively treated and without ongoing therapeutic intervention, and nonmelanomatous skin cancers curatively treated.
- No concomitant use of complementary or alternative medication or other agents (investigational or anti-cancer agents) will be allowed without approval of a principal investigator (PI) or associate investigator (AI). Every effort will be made to maximize patient safety and minimize changes in chronic medications.
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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