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Clinical Trials/NCT01313078
NCT01313078CompletedPhase 2

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

National Cancer Institute (NCI)1 site in 1 country4 target enrollmentStarted: January 2010Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
4
Locations
1
Primary Endpoint
Evaluation of Safety in Patients With Ovarian, Fallopian Tube, and/or Primary Peritoneal Cancer.
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Detailed Description

Background:

  • The bacterial enzyme L-asparaginase (L-ASP) catalyzes hydrolysis of asparagine to aspartate and is used to treat acute lymphoblastic leukemia (ALL).Studies demonstrated in vitro cytotoxic activity against solid tumor types including ovarian cancer.
  • Our laboratory demonstrated L-ASP inhibits vascular remodeling and modulates heterotypic adhesion interactions between ovarian cancer cells and endothelial cells. Results indicate L-ASP has the ability to modify the local tumor microenvironment.
  • Epithelial ovarian cancer requires neovascularization for growth and metastasis. Anti-angiogenesis agents show promise in treatment of recurrent disease.
  • The pegylated form of L-ASP, pegaspargase, (Sigma Tau ONCASPAR (Trademark)) is shown to deplete serum levels of asparagine and is approved for ALL. ONCASPAR is in clinical trial with gemcitabine for pancreatic cancer and other solid tumors.
  • Recommended dose of pegaspargase in ALL is 2,500 IU/m^2 every two weeks intramuscular (IM)/intravenous (IV). IM dosing of 2,000 IU/m^2 every two weeks has been studied in a phase I protocol with various solid tumors.
  • Demonstration of safety and anti-angiogenic activity will lead to combination studies.

Primary Objectives:

  • To preliminarily evaluate the anti-tumor activity of pegaspargase, 2,000 IU/ m^2 every two weeks intravenous (IV) (or intramuscular (IM)) and explore associations with toxicity and clinical outcome.
  • To evaluate the safety of pegaspargase in patients with recurrent or refractory ovarian, fallopian tube, and/or primary peritoneal cancer.

Secondary Objectives:

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Pegaspargase in women with cancer

Experimental

Pegaspargase 2000 IU/m^2 intramuscular or intravenously every 2 weeks

Intervention: Pegylated L-Asparaginase (Drug)

Outcomes

Primary Outcomes

Evaluation of Safety in Patients With Ovarian, Fallopian Tube, and/or Primary Peritoneal Cancer.

Time Frame: 11 months, 25 days

Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.

6 Month Progression Free Survival

Time Frame: 6 months

Proportion of patients able to attain a 6 month progression free survival. Progressive disease is defined as \>20% increase in the sum of the longest diameter of all target lesions, or the unequivocal increase in size of non-measurable lesions agreed upon by two investigators, or the appearance of new lesions.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Nih

Study Sites (1)

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