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

NCT01313078 | Completed Phase 2 Results

• 2 other identifiers: 10002810-C-0028
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms; Primary Peritoneal Neoplasms

Keywords

Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer; Relapsed or Refractory; Pegaspargase; Pegylated L-Asparaginase

Outcome Measures

Primary Outcomes (2)

• 6 Month Progression Free Survival

  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.

  6 months

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

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

  11 months, 25 days

Study Arms (1)

Pegaspargase in women with cancer

EXPERIMENTAL

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

Drug: Pegylated L-Asparaginase

Interventions

Pegylated L-Asparaginase DRUG

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

Also known as: Oncaspar

Pegaspargase in women with cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Jemal A, Siegel R, Ward E, Hao Y, Xu J, Murray T, Thun MJ. Cancer statistics, 2008. CA Cancer J Clin. 2008 Mar-Apr;58(2):71-96. doi: 10.3322/CA.2007.0010. Epub 2008 Feb 20.

  PMID: 18287387 BACKGROUND

• Liotta LA, Kohn EC. The microenvironment of the tumour-host interface. Nature. 2001 May 17;411(6835):375-9. doi: 10.1038/35077241.

  PMID: 11357145 BACKGROUND

• Alvarez AA, Krigman HR, Whitaker RS, Dodge RK, Rodriguez GC. The prognostic significance of angiogenesis in epithelial ovarian carcinoma. Clin Cancer Res. 1999 Mar;5(3):587-91.

  PMID: 10100710 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms; Recurrence

Interventions

pegaspargase

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Elise Kohn, M.D.
• Organization: National Cancer Institute, National Institutes of Health

kohne@mail.nih.gov

301-496-9336

Study Officials

• Elise C Kohn, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: March 9, 2011
• First Posted: March 11, 2011
• Study Start: January 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 9, 2015
• Results First Posted: September 12, 2012

Record last verified: 2012-08

Locations

US (1)