Phase 2
N=4
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
Ovarian Neoplasms · Fallopian Tube Neoplasms · Primary Peritoneal Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT01313078 ↗Enrolled (actual)
4
Serious AEs
50.0%
Results posted
Sep 2012
Primary outcome: Primary: 6 Month Progression Free Survival — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pegylated L-Asparaginase (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 6 Month Progression Free Survival |
— | — |
| PRIMARY Evaluation of Safety in Patients With Ovarian, Fallopian Tube, and/or Primary Peritoneal Cancer. |
4 | — |
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.
Eligibility Criteria
- INCLUSION CRITERIA:
- All patients 18 years and older with epithelial ovarian, fallopian tube, or primary peritoneal cancer that is persistent, relapsed or refractory to prior standard platinum and taxane-based therapy will be eligible. Tumor histology must be reviewed and confirmed by the National Cancer Institute (NCI) Laboratory of Pathology. Recurrent ovarian cancer is not a curable tumor. Patients who are platinum-sensitive and who, upon detailed informed consent, wish to consider this experimental regimen, will be considered.
- All patients must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. A sentinel lesion adequate for core biopsy through percutaneous route is ideal but not mandatory. Patients with a malignant pleural effusion or malignant ascites will be allowed to undergo a paracentesis or thoracentesis rather than core needle biopsy if the procedure may be performed safely.
- Patients must have a performance status of Eastern Cooperative Oncology Group (ECOG) = 0, 1, 2
- Patients must have adequate end organ function:
- Absolute neutrophil count (ANC) greater than or equal to 1500/ mm^3
- Platelets greater than or equal to 100,000/ mm^3
- Serum creatinine less than or equal to 1.5 mg/dL, or if low, creatinine clearance greater than or equal to 60 mL/min
- Total bilirubin less than or equal to 1.5 times the ULN (upper limit of normal) unless a history of Gilbert's disease.
- Lipase and amylase less than or equal to 1.5 times the ULN
- Transaminases (aspartate aminotransferase (AST), alanine aminotransferase (ALT)) less than or equal to 2.5 times the ULN
- Fibrinogen greater than or equal to 0.75 times the LLN
- Prothrombin time (PT), partial thromboplastin time (PTT), and International Normalized Ratio (INR) less than or equal to 1.5 times the ULN. Coagulation parameters must be drawn peripherally.
- Patients must be at least 4 weeks from previous therapy (chemotherapy, hormonal therapy, and radiation therapy, alternative therapy, investigational agents, or a major surgical procedure). Patients must be 6 weeks from carboplatin- or mitomycin C-containing therapy. Exceptions: Raloxifene will be allowed for bone health and bisphosphonate therapy will be allowed for the rare situation of bone metastasis.
- There is no limit to the number of prior regimens patients may have received for the treatment of ovarian cancer.
- Patients must have recovered from any toxicity related to prior cancer therapy to Common Terminology Criteria for Adverse Events (CTCAE) grade 1, except for stable peripheral neuropathy, which must have recovered to grade 2 or better, and grade 2 total white blood cell count when ANC is greater than or equal to 1500 (alopecia and hypertension exempted).
- Women of childbearing potential must agree to use adequate barrier contraception (interaction with oral contraceptives is unknown) prior to study entry, during therapy and for 3 months after completion of therapy and must have a negative pregnancy test.
- Patients must be able to give written informed consent.
EXCLUSION CRITERIA
- 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 war
Data sourced from ClinicalTrials.gov (NCT01313078). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.