Irinotecan and Bevacizumab for Recurrent Ovarian Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01091259
First received: March 19, 2010
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

The purpose of the study is to evaluate the efficacy and toxicity of irinotecan in the treatment of women with recurrent epithelial ovarian cancer or primary peritoneal cancer when combined with bevacizumab.


Condition Intervention Phase
Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Carcinoma
Drug: Irinotecan and Bevacizumab
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Irinotecan in Combination With Bevacizumab for the Treatment of Recurrent Ovarian Cancer.

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • 6-month progression free survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    This is the total time needed to satisfy the endpoint.


Secondary Outcome Measures:
  • response rate [ Time Frame: up to 6 years from the start of the trial ] [ Designated as safety issue: No ]
  • time to progression [ Time Frame: up to 6 years from the start of the trial ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: up to 6 years from the start of the trial ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: March 2010
Estimated Study Completion Date: December 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Irinotecan with Bevacizumab Drug: Irinotecan and Bevacizumab

Irinotecan is administered every 3 weeks at a dose of 175 mg/m^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab.

Patients will continue on therapy until evidence of disease progression, or until development of adverse effects that prevent further treatment, or if the patient wishes to discontinue therapy.

Other Names:
  • Bevacizumab:Avastin
  • Irinotecan: Camptosar
  • Irinotecan: CPT-11

Detailed Description:

Accumulating data suggests that angiogenesis plays a critical role in the formation and development of a number of solid tumors including ovarian cancer. For women with ovarian cancer, a direct relationship between VEGF expression and tumor vascularity has been documented. In vivo and in vitro data has demonstrated that increased angiogenesis and microvessel density are negative prognostic factors for women with ovarian cancer. These observations have fueled interest in incorporating anti-angiogenic agents into ovarian cancer treatment regimens.

Several phase II trials of irinotecan in patients with epithelial ovarian cancer showed that the drug had efficacy in both chemotherapy-naïve patients and in those who had been previously treated with standard therapies, including platinum-based compounds, radiation, or both. Combination of bevacizumab, an antibody against VEGF, and irinotecan was studied in colorectal cancer and malignant brain neoplasms. In these trials, the combination was shown to be safe and effective.

The purpose of this study is to evaluate the efficacy and toxicity of irinotecan in the treatment of women with recurrent epithelial ovarian cancer or primary peritoneal cancer when combined with bevacizumab. In this phase II open-label study patients will be treated with bevacizumab 15 mg/kg and irinotecan 175mg/m^2 every 3 weeks. Patients will undergo pre-treatment evaluation within 4 weeks of enrolling into the study. Clinical and laboratory evaluation will be performed every 3 weeks. Imaging studies and CA-125 measurements will be used to assess response to treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma
  • Patient should have measurable or evaluable disease as defined by the following.
  • Measurable disease: At least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be ≥ 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT and MRI, or ≥ 10 mm when measured by spiral CT.
  • Evaluable (nonmeasurable) disease: Patients who do not meet measurable criteria will be eligible having known disease with CA125 levels >50 U/mL on two occasions at least one week apart. They will be considered for CA-125 response criteria.
  • Any number of prior chemotherapy regimens
  • Any number of prior bevacizumab-containing regimens
  • No chemotherapy within the last 2 weeks prior to initiating this study.
  • Karnofsky Performance status score ≥ 60%.
  • Patients must have a life expectancy ≥ 12 weeks.
  • Patients must be at least 18 years of age.
  • Patients must understand and willingly sign an approved informed consent.

Exclusion Criteria:

  • Inability to comply with study and/or follow-up procedures
  • Life expectancy of less than 12 weeks
  • Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study
  • Active malignancy, other than superficial basal cell and superficial squamous (skin) cell, or carcinoma in situ of the cervix within last five years

Bevacizumab-Specific Exclusions

  • Inadequately controlled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg)
  • Prior history of hypertensive crisis or hypertensive encephalopathy
  • New York Heart Association (NYHA) Grade II or greater congestive heart failure
  • History of myocardial infarction or unstable angina within 6 months prior to Day 1
  • History of stroke or transient ischemic attack within 6 months prior to Day 1 Known CNS disease, except for treated brain metastasis
  • Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, LINAC, or equivalent) or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded
  • Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1
  • History of hemoptysis (>= 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1
  • Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 or anticipation of need for major surgical procedure during the course of the study
  • Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1
  • History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1
  • Serious, non-healing wound, active ulcer, or untreated bone fracture
  • Proteinuria as demonstrated by a UPC ratio >= 1.0
  • Known hypersensitivity to any component of bevacizumab
  • Pregnancy (positive pregnancy test) or lactation. Use of effective means of contraception (men and women) in subjects of child-bearing potential
  • History of abdominal fistula or intra-abdominal abscess within 6 months prior to start.
  • Any history of prior gastrointestinal perforation
  • Patients believed to possibly be at higher than average risk of perforation, including symptoms or findings of partial or complete bowel obstruction, history of fistula, patients requiring parenteral nutrition and hydration, and those with history of prior perforation due to tumor or perforation within last 6 months from other causes will be excluded from study
  • Patients with evidence of abdominal free air not explained by paracentesis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01091259

Locations
United States, New York
New York University Clinical Cancer Center
New York, New York, United States, 10016
Bellevue Hospital Center (NYU Langone Medical Center affiliate)
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Genentech
Investigators
Principal Investigator: Franco Muggia, MD New York Unviersity Cancer Institute
  More Information

No publications provided

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01091259     History of Changes
Other Study ID Numbers: NYU 09-0029
Study First Received: March 19, 2010
Last Updated: April 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
antibody therapy
chemotherapy
biologic therapy
combination therapy

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Bevacizumab
Irinotecan
Camptothecin
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014