- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01821859
Abraxane/Bevacizumab
A Phase II Evaluation of Abraxane Plus Bevacizumab for the Treatment of Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Oregon
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Portland, Oregon, United States, 97239
- OHSU Knight Cancer Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients must have histologically or cytologically confirmed recurrent epithelial ovarian, fallopian tube or primary peritoneal carcinoma. Histologic documentation of the original primary tumor is required via the pathology report.
- All patients must have measurable disease. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be >20mm when measured by conventional techniques including CT, and MRI, or >10 mm when measured by spiral CT.
- Patients must have at least one "target lesion" to be used to assess response as defined by RECIST. Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.
- Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound. This initial treatment may have included intraperitoneal therapy, high-dose therapy, consolidation, non-cytotoxic agents or extended therapy administered after surgical or non-surgical assessment.
- Patients are required to receive at least one additional cytotoxic regimen for management of recurrent or persistent disease. Patients are allowed to receive, but are not required to receive, biologic (non-cytotoxic) therapy either alone or as part of the cytotoxic regimens for management of recurrent or persistent disease.
- Age >18 years. Women all races and ethnic groups will be included.
- Patients with an ECOG performance status < 2. ( see APPENDIX A)
- Patients must have normal organ and marrow function as defined below:
- absolute neutrophil count >1,500/uL
- platelets >100,000/uL
- hemoglobin >9 g/dL
- total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal
- Alkaline Phosphatase within normal institutional limits
- creatinine <1.5 X institutional upper limit of normal
- Neurologic function: Neuropathy (sensory and motor) less than or equal to CTCAE v4.0 grade 2. (see APPENDIX B)
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- Patients who have had chemotherapy or radiotherapy within 28 days prior to entering the study or whose adverse events due to agents administered more than 28 days earlier continue to be grade 3 or greater.
- Patients may not have received any other investigational agents within the past 28 days.
- Any hormonal therapy or immunotherapy directed at the malignant tumor must be discontinued at least one week prior to enrollment. Continuation of hormone replacement therapy is permitted. Continuation of other established medical treatments for a known medical condition is permitted.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Abraxane or Bevacizumab.
- Patients who have had prior therapy with Abraxane.
- Patients who have received radiation to more than 25% of marrow-bearing areas. (see APPENDIX C)
- Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years.
- Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the last five years are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than five years prior to registration, and the patient remains free of recurrent or metastatic disease.
- Patients who have known active liver disease or hepatitis.
- Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels.
- Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within 6 months of the first date of treatment on this study.
- Patients with clinically significant cardiovascular disease, including:
uncontrolled hypertension, myocardial infarction, unstable angina within 6 months of enrollment, NYHA Grade II or greater heart failure, serious cardiac arrhythmia requiring medication, grade II or greater peripheral vascular disease.
- Patients with clinically significant proteinuria. Patients with a urine protein of 1+ on dipstick should undergo a 24-hour urine collection, which must demonstrate < 100 mg protein/24 hr to allow participation in the study.
- Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies.
- Patients who have a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment on the study, or anticipation of need for major surgical procedure during the course of the study.
- Patients who have received commercial bevacizumab within 28 days prior to enrollment on the study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection(with the exception of uncomplicated UTI), chronic non- healing wound, bone fracture, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant or lactating women are excluded from this study because of possible risk to the fetus or infant.
- Known HIV-positive patients are excluded from the study because of possible risk of lethal infection when treated with marrow suppressive therapy.
- Safety data regarding Abraxane use in patients with ascites is not available; therefore patients with symptomatic ascites will be excluded from participation in the study. Patients may have asymptomatic ascites.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Abraxane/Bevacizumab
Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion. Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion. |
Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes.
This will follow the Bevacizumab infusion.
Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes.
It is given first, prior to the Abraxane infusion.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Progression Free Survival Rate at 6 Months as Defined as Complete Response, Partial Response, or Stable Disease.
Time Frame: 6 months after start of dosing
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Using RECIST criteria, Complete Response (CR)= disappearance of all target lesions, Partial Response (PR)= At least a 30% decrease in the sum of the longest diameter of target lesions, and Stable Disease (SD)= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as progressive disease.
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6 months after start of dosing
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tanja Pejovic, MD, PhD, OHSU Knight Cancer Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00005859
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ovarian Cancer
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Roswell Park Cancer InstituteCompletedFallopian Tube Carcinoma | Primary Peritoneal Carcinoma | Stage IIA Ovarian Cancer | Stage IIB Ovarian Cancer | Stage IIC Ovarian Cancer | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian Cancer | Stage IA Ovarian Cancer | Stage IB Ovarian Cancer | Stage IC... and other conditionsUnited States
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City of Hope Medical CenterNational Cancer Institute (NCI)CompletedCancer Survivor | Stage IIIA Ovarian Epithelial Cancer | Stage IIIB Ovarian Epithelial Cancer | Stage IIIC Ovarian Epithelial Cancer | Stage IIA Ovarian Epithelial Cancer | Stage IIB Ovarian Epithelial Cancer | Stage IIC Ovarian Epithelial Cancer | Stage IA Ovarian Epithelial Cancer | Stage IB Ovarian... and other conditionsUnited States
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Massachusetts General HospitalJohns Hopkins University; M.D. Anderson Cancer Center; National Cancer Institute... and other collaboratorsRecruitingOvarian Neoplasms | Fallopian Tube Neoplasms | Stage III Ovarian Cancer AJCC v8 | Stage IIIA Ovarian Cancer AJCC v8 | Stage IIIA1 Ovarian Cancer AJCC v8 | Stage IIIA2 Ovarian Cancer AJCC v8 | Stage IIIB Ovarian Cancer AJCC v8 | Stage IIIC Ovarian Cancer AJCC v8 | Stage IV Ovarian Cancer AJCC v8 | Stage... and other conditionsUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedOvarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Seromucinous Carcinoma | Ovarian Serous Cystadenocarcinoma | Stage IV Ovarian Germ Cell Tumor | Ovarian Sarcoma | Malignant Ovarian Epithelial Tumor | Ovarian Carcinosarcoma | Ovarian Brenner Tumor | Ovarian Mucinous... and other conditionsUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedStage IIA Fallopian Tube Cancer | Stage IIA Ovarian Cancer | Stage IIB Fallopian Tube Cancer | Stage IIB Ovarian Cancer | Stage IIC Fallopian Tube Cancer | Stage IIC Ovarian Cancer | Stage IIIA Fallopian Tube Cancer | Stage IIIA Ovarian Cancer | Stage IIIA Primary Peritoneal Cancer | Stage IIIB Fallopian... and other conditionsUnited States
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University of WashingtonNational Cancer Institute (NCI)CompletedCaregiver | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
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Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
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Eve RodlerNot yet recruitingBreast Cancer | Ovarian Cancer | Breast Neoplasm | Breast Carcinoma | Breast Cancer Stage IV | Breast Cancer Stage I | Breast Cancer Stage II | Invasive Breast Cancer | Cancer, Breast | Breast Cancer Stage III | Ovary Cancer | Malignant Tumor of Breast | Ovarian Cancer Stage IIIC | Ovarian Cancer Stage IV | Ovarian Cancer... and other conditionsUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)RecruitingStage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian CancerUnited States
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Clinical Trials on Abraxane
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M.D. Anderson Cancer CenterNational Comprehensive Cancer NetworkCompletedSolid Tumors | Liver Cancer | Advanced CancersUnited States
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Fudan UniversityCompletedMetastatic Breast CancerChina
-
Kaiser PermanenteCelgene CorporationCompletedProstate CancerUnited States
-
Southeastern Gynecologic OncologyCelgene CorporationCompletedOvarian Cancer | Fallopian Tube Cancer | Primary Peritoneal CancerUnited States
-
Orinove, Inc.Active, not recruitingMetastatic Breast Cancer | Advanced Solid TumorUnited States
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West Virginia UniversityOrtho Biotech, Inc.CompletedMetastatic Breast CancerUnited States
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Gruppo Oncologico Italiano di Ricerca ClinicaIstituto Toscano Tumori; Temas srl; Clirest s.r.l.; Mipharm S.p.A.UnknownSmall Cell Lung CancerItaly
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University Health Network, TorontoCelgene CorporationCompleted
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Processa PharmaceuticalsCompletedMetastatic Pancreatic CancerUnited States