Irinotecan and Bevacizumab for Recurrent Ovarian Cancer

NCT01091259 | Completed Phase 2 Results DMC

• 1 other identifier: NYU 09-0029
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma

Keywords

antibody therapy; chemotherapy; biologic therapy; combination therapy

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) Rate at 6 Months

  The PFS rate at 6 months is the percentage of patients that experience a PFS event during the first 6 months in the study. The PFS is defined as the time from date of first dose of study medication to the date of first documented disease progression, or death from any cause, whichever is first. Patients who die without a reported prior progression will be considered to have progressed on the day of their death. Progression is evaluated by Response and Evaluation Criteria in Solid Tumor (RECIST) 1.0 or CA125 criteria if no measurable disease as doubling of CA125 levels from either the upper limit of normal or the nadir CA125 level.

  6 months from the start of treatment

Secondary Outcomes (4)

• Overall Response Rate (ORR)

  up to 3 years

• Median Progression Free Survival

  up to 3 years

• Median Overall Survival

  up to 3 years

• Number of Patients Who Experienced Grade 3 and Higher Toxicities

  up to 3 years

Study Arms (1)

Irinotecan with Bevacizumab

EXPERIMENTAL

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 events that prevent further treatment, or if the patients wishes to discontinue therapy.

Drug: Irinotecan; Drug: Bevacizumab

Interventions

Irinotecan DRUG

Also known as: Camptosar, CPT-11

Irinotecan with Bevacizumab

Bevacizumab DRUG

Also known as: Avastin

Irinotecan with Bevacizumab

Eligibility Criteria

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

You may qualify if:

• 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 CA125 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.

You may not qualify if:

• 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
• 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 central nervous system 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

Sponsors & Collaborators

• NYU Langone Health: lead
• Genentech, Inc.: collaborator

Study Sites (2)

Bellevue Hospital Center (NYU Langone Medical Center affiliate)

New York, New York, 10016, United States

Location

New York University Clinical Cancer Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

Irinotecan; Bevacizumab

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

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Franco Muggia, MD
• Organization: Perlmutter Cancer Center at NYU Lagone

Franco.Muggia@nyumc.org

212-263-6485

Study Officials

• Franco Muggia, MD

  New York Unviersity Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2010
• First Posted: March 23, 2010
• Study Start: March 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: May 1, 2015
• Last Updated: November 24, 2015
• Results First Posted: October 19, 2015

Record last verified: 2015-10

Locations

US (2)