- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00923130
Bevacizumab Plus Ixabepilone to Treat Patients With Advanced Kidney Cancer
A Phase II Multi-Center Study of Bevacizumab in Combination With Ixabepilone in Subjects With Advanced Renal Cell Carcinoma
Background:
- Substantial preclinical antitumor synergy supports the exploration of the combination of antiangiogenic compounds (including sunitinib and bevacizumab) plus ixabepilone. In Vivo, synergistic activity between ixabepilone and bevacizumab has been demonstrated using the 151-B human renal carcinoma xenograft model and this synergy compares favorably with other antiangiogenic inhibitors (i.e. sunitinib).
- Combination therapies of bevacizumab with chemotherapy demonstrated improved benefit compared with single-agent cytotoxics in multiple animal models and in humans.
- Clinical activity of both compounds used as single agents has been demonstrated in a broad spectrum of solid tumors. Bevacizumab and ixabepilone, when used as a single agent, have demonstrated substantial activity in renal cell carcinoma.
- Phase II studies with bevacizumab and ixabepilone suggest the absence of overlapping toxicities.
- Development of a well-tolerated and active bevacizumab/ixabepilone combination has the potential to further improve the treatment of metastatic renal cell carcinoma (mRCC), and could represent a second-line option after sunitinib or sorafenib are no longer of benefit or are intolerable.
Primary Objectives:
- Determine the objective response rate of the combination of ixabepilone and bevacizumab in patients with relapsed or refractory mRCC.
- Determine progression-free survival.
- Characterize the toxicity of the combination of ixabepilone and bevacizumab in patients with mRCC.
- Determine changes in biomarkers and evaluate correlation with clinical outcomes.
Eligibility:
- Pathologic confirmation of renal cell carcinoma (clear cell histology) by the Laboratory of Pathology, National Cancer Institute (NCI), or the Medical University of South Carolina.
- Presence of metastatic renal carcinoma, after progression or intolerance to Vascular endothelial growth factor receptor (VEGFR) inhibitors (sunitinib and/or sorafenib).
- Adequate organ and bone marrow function.
Design:
- Multi-center, open labeled phase II study
- Following a Simon two-stage optimal design, a maximum of 58 patients with metastatic RCC will be accrued.
- Ixabepilone will be administered daily as a one hour infusion on five successive days (daily x 5), every three weeks (one cycle equals 3 weeks or 21 days +/- 5 days). Following cycle 6, cycles will be spread out to 4 weeks or 28 days +/- 5 days. The starting dose will be a daily dose of 6 mg/m(2)/day, for a total per cycle dose of 30 mg/m(2).
- In addition, 15 mg/kg bevacizumab will be administered intravenously on day 1 of each cycle. The first infusion of bevacizumab will be 90 minutes in duration, the second 60 minutes in duration, and in all subsequent cycles bevacizumab will be infused over 30 minutes if prior infusions are well tolerated.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background:
- Substantial preclinical antitumor synergy supports the exploration of the combination of antiangiogenic compounds (including sunitinib and bevacizumab) plus ixabepilone. In Vivo, synergistic activity between ixabepilone and bevacizumab has been demonstrated using the 151-B human renal carcinoma xenograft model and this synergy compares favorably with other antiangiogenic inhibitors (i.e. sunitinib).
- Combination therapies of bevacizumab with chemotherapy demonstrated improved benefit compared with single-agent cytotoxics in multiple animal models and in humans.
- Clinical activity of both compounds used as single agents has been demonstrated in a broad spectrum of solid tumors. Bevacizumab and ixabepilone, when used as a single agent, have demonstrated substantial activity in renal cell carcinoma.
- Phase II studies with bevacizumab and ixabepilone suggest the absence of overlapping toxicities.
- Development of a well-tolerated and active bevacizumab/ixabepilone combination has the potential to further improve the treatment of metastatic renal cell carcinoma (mRCC), and could represent a second-line option after sunitinib or sorafenib are no longer of benefit or are intolerable.
Primary Objectives:
- Determine the objective response rate of the combination of ixabepilone and bevacizumab in patients with relapsed or refractory mRCC.
- Determine progression-free survival.
- Characterize the toxicity of the combination of ixabepilone and bevacizumab in patients with mRCC.
- Determine changes in biomarkers and evaluate correlation with clinical outcomes.
Eligibility:
- Pathologic confirmation of renal cell carcinoma (clear cell histology) by the Laboratory of Pathology, National Cancer Institute (NCI), or the Medical University of South Carolina.
- Presence of metastatic renal carcinoma, after progression or intolerance to vascular endothelial growth factor receptor (VEGFR) inhibitors (sunitinib and/or sorafenib).
- Adequate organ and bone marrow function.
Design:
- Multi-center, open labeled phase II study
- Following a Simon two-stage optimal design, a maximum of 58 patients with metastatic RCC will be accrued.
- Ixabepilone will be administered daily as a one hour infusion on five successive days (daily x 5), every three weeks (one cycle equals 3 weeks or 21 days +/- 5 days). Following cycle 6, cycles will be spread out to 4 weeks or 28 days +/- 5 days. The starting dose will be a daily dose of 6 mg/m(2)/day, for a total per cycle dose of 30 mg/m(2).
- In addition, 15 mg/kg bevacizumab will be administered intravenously on day 1 of each cycle. The first infusion of bevacizumab will be 90 minutes in duration, the second 60 minutes in duration, and in all subsequent cycles bevacizumab will be infused over 30 minutes if prior infusions are well tolerated.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- University of South Carolina
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- INCLUSION CRITERIA:
Subjects meeting all of the following criteria will be considered for enrollment into the study:
- Pathologic confirmation of metastatic or unsectable renal cell carcinoma with predominant clear cell histology (greater than 70%) by the Laboratory of Pathology, National Cancer Institute (NCI) or the Medical University of South Carolina..
- Progression on or after stopping treatment with an agent approved by the Food and Drug Administration (FDA) for the treatment of renal cell carcinoma (RCC). Patients must have received at least one FDA approved agent (axitinib, sunitinib, sorafenib, pazopanib, temsirolimus, interleukin-2 (IL-2), interferon or everolimus). Patients must be off prior IL-2 or interferon for 4 weeks prior to entry. They must be off sunitinib, sorafenib, pazopanib, axitinib, temsirolimus or everolimus or other tyrosine kinase inhibitor (TKIs) for 2 weeks prior to entry.
- Eighteen years of age or older.
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
- Resolution of any toxic effects of prior therapy (except alopecia) to NCI Common Terminology Criteria in Solid Tumors (CTCAE) v.3.0 through 12/31/10 and version 4.0 beginning 1/1/11 grade less than or equal to 1 and to baseline laboratory values as defined in inclusion criterion # 6.
Adequate organ and bone marrow function as evidenced by:
- hemoglobin greater than or equal to 9.0 g/dL
- absolute neutrophil count greater than or equal to 1.5 x 10(9)/L
- platelet count greater than or equal to 100 x 10(9)/L
- creatinine less than or equal to 1.5 times the ULN, OR measured creatinine clearance greater than or equal to 40 ml/min
- urine proteinuria less than 20mg/dL on random protein creatinine ratio urine samples or a 24-hour urine protein less than 500 mg. NOTE: If on a random protein creatinine ratio the urine protein is greater that or equal to 20mg/dL, then obtain a 24 hour urine collection to accurately demonstrate that the 24 hour total is less than 500 mg/24 hours.
- aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) less than or equal to 2.5 times the upper limit of normal (ULN) (or less than or equal to 5 times the ULN if liver function abnormalities due to underlying malignancy)
- total bilirubin less than or equal to 1.5 times the ULN
- Subjects must be postmenopausal, surgically sterile, or using effective contraception. All female subjects of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment. Effective contraception includes hormonal or barrier methods.
- No other invasive malignancies within the past two years (with the exception of nonmelanoma skin cancers, non-invasive bladder cancer, stage I endometrial cancer or cervical cancer).
- Subjects must agree to sign and date an Institutional Review Board (IRB)-approved subject informed consent form.
- Subjects must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- Patients must have measurable disease either by conventional imaging or clinical examination.
EXCLUSION CRITERIA:
Subjects presenting with any of the following will not be included in the study:
Invasive procedures defined as follows:
- Major surgical procedure, open biopsy or significant traumatic injury within 6 weeks prior to Day 1 therapy
- Anticipation of need for major surgical procedures during the course of the study
- Minor surgery, such as port-a-cath placement, and dental procedures, within 2 weeks.
- (There will be no delay for percutaneous core biopsies or peripherally inserted central catheter (PICC)/internal jugular (IJ) line placement)
- Cumulative radiation therapy to greater than 25% of the total bone marrow.
- History of uncontrolled or labile hypertension, defined as blood pressure greater than 160/90 mm Hg (NCI CTCAE v.3.0 through 12/31/10 and version 4.0 beginning 1/1/11 grade greater than or equal to 2), on at least 2 repeated determinations on separate days within 15 days prior to study enrollment.
- Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class III or IV congestive heart failure; cerebrovascular accident or transient ischemic attack, grade greater than or equal to 2 peripheral neuropathy, peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, or other thromboembolic event.
- Symptomatic spinal cord compression.
- Evidence of clinically significant bleeding diathesis or underlying coagulopathy.
- Antiretroviral therapy for human immunodeficiency virus (HIV) disease.
- Pregnant (positive pregnancy test) or nursing women. Both fertile men and women must agree to use adequate contraceptive measures during study therapy and for at least 6 months after the completion of bevacizumab therapy.
- Other severe acute or chronic medical or psychiatric condition, or significant laboratory abnormality requiring further investigation that may cause undue risk for the subjects safety, 18 inhibit protocol participation, or interfere with interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
- Prior therapy with bevacizumab
- Prior therapy with ixabepilone.
- Patients on anticoagulant therapy will be evaluated on a case by case basis for inclusion.
- Serious or non-healing wound, ulcer or bone fracture
- History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to day 1
- Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1
Known central nervous system (CNS) disease except for treated brain metastasis.
-Treated brain metastases are defined as having no ongoing requirement for steroids and no evidence of progression or hemorrhage after treatment for at least 3 months, as ascertained by clinical examination and brain imaging (magnetic resonance imaging (MRI) or computed tomography (CT)). (Stable dose of anticonvulsants are allowed). Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, linear particle accelerator (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.
- Patients with known hypersensitivity of Chinese hamster ovary cell products or other recombinant human antibodies
- Patients receiving cytochrome P450 3A4 (CYP3A4) inhibitors in section 3.6 that cannot be discontinued.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bevacizumab with Ixabepilone
Bevacizumab 15mg/kg every 3 weeks Ixabepilone given on days 1,2,3,4 and 5 of each three week cycle at a dose of 6mg/m(2)/day
|
Bevacizumab will be administered intravenously every 3 weeks on an outpatient basis with the exception of admissions for the purpose of facilitating research studies.
The dose of bevacizumab to be given is 15 mg/kg.
Other Names:
Ixabepilone will be given on days 1, 2, 3, 4, and 5 of each three week cycle as a one hour intravenous infusion.
The dose will be 6 mg/m(2)/day on five successive days.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free Survival
Time Frame: up to 44 months
|
The time between the first day of treatment to the day of disease progression.
Progression is defined by the Response Evaluation Criteria in Solid Tumors (RECIST).
Progression is at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
|
up to 44 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With an Objective Response (Complete Response (CR) or Partial Response (PR)) Per the Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame: Two Years
|
Response (complete response (CR) and partial response (PR)) was measured by the RECIST.
Complete response is the disappearance of all target lesions.
Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.
|
Two Years
|
Number of Participants With Adverse Events
Time Frame: Date treatment consent signed to date off study, approximately 84 months and 25 days
|
Here is the number of participants with adverse events.
For the detailed list of adverse events, see the adverse event module.
Adverse events are assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
|
Date treatment consent signed to date off study, approximately 84 months and 25 days
|
Number of Participants Who Had Biopsies
Time Frame: Baseline and Cycle 2 Day 1
|
To obtain tumor tissue and perform analysis for molecular changes in the tumor before and after a cycle of chemotherapy.
|
Baseline and Cycle 2 Day 1
|
Overall Survival
Time Frame: Time between the first day of treatment and the day of death, assessed up to approximately 7 years.
|
Time between the first day of treatment and the day of death.
|
Time between the first day of treatment and the day of death, assessed up to approximately 7 years.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Protein Profiling of Vascular Endothelial Growth Factor A (VEGF-A), Vascular Endothelial Growth Factor Receptor 2 (VEGFR-2), Vascular Endothelial Growth Factor Receptor 3 (VEGFR-3), Beta Fibroblast Growth Factor (βFGF) and Erythropoietin From Baseline
Time Frame: Cycle 1 Day 5 (C1D5), Cycle 2 Day 1 (C2D1), Cycle 4 and Cycle 6
|
This assessment was intended as an exploratory analysis.
|
Cycle 1 Day 5 (C1D5), Cycle 2 Day 1 (C2D1), Cycle 4 and Cycle 6
|
Circulating Endothelial Cells (CECs)
Time Frame: Baseline, Day 5, and Cycle 2 Day 1
|
This assessment was intended as an exploratory analysis.
|
Baseline, Day 5, and Cycle 2 Day 1
|
Micro Vessel Density
Time Frame: Prior to cycle 2
|
This assessment was intended as an exploratory analysis
|
Prior to cycle 2
|
Tumor Endothelial Markers (TEMs)
Time Frame: Cycle 1 Day 5, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 6 Day 1
|
This assessment was intended as an exploratory analysis.
|
Cycle 1 Day 5, Cycle 2 Day 1, Cycle 4 Day 1, and Cycle 6 Day 1
|
Growth Rate Constant (g)
Time Frame: up to 50 days
|
This assessment was intended as an exploratory analysis.
|
up to 50 days
|
Percentage of Participants With an Increase or Decrease in Forward Contrast Transfer Rate (Ktrans) Using MRI Versus Conventional Imaging
Time Frame: Cycle 1 before day 1 of treatment and day 5 following infusion
|
This assessment was intended as an exploratory analysis.
|
Cycle 1 before day 1 of treatment and day 5 following infusion
|
Percentage of Participants With an Increase or Decrease in Reverse Contrast Transfer Rate (Kep) Using MRI Versus Conventional Imaging
Time Frame: Cycle 1 before day 1 of treatment and day 5 following infusion
|
This assessment was intended as an exploratory analysis.
|
Cycle 1 before day 1 of treatment and day 5 following infusion
|
Regression Rate Constant (d)
Time Frame: up to 50 days
|
This assessment was intended as an exploratory analysis.
|
up to 50 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Ryan AM, Eppler DB, Hagler KE, Bruner RH, Thomford PJ, Hall RL, Shopp GM, O'Neill CA. Preclinical safety evaluation of rhuMAbVEGF, an antiangiogenic humanized monoclonal antibody. Toxicol Pathol. 1999 Jan-Feb;27(1):78-86. doi: 10.1177/019262339902700115.
- Ferrara N, Chen H, Davis-Smyth T, Gerber HP, Nguyen TN, Peers D, Chisholm V, Hillan KJ, Schwall RH. Vascular endothelial growth factor is essential for corpus luteum angiogenesis. Nat Med. 1998 Mar;4(3):336-40. doi: 10.1038/nm0398-336.
- Hellman S, Rosenthal DS, Moloney WC, Chaffey JT. The treatment of non-Hodgkin's lymphoma. Cancer. 1975 Aug;36(2):804-8. doi: 10.1002/1097-0142(197508)36:2+3.0.co;2-w.
- Phase II clinicaltrial of bevacizumab plus ixabepilone in renal cell carcinoma. Mauricio Emmanuel Burotto Pichun, Nicolas Acquavella, Maureen Edgerly, Susan Elaine Bates, Sanjeeve Balasubramaniam and Antonio Tito Fojo; Journal of Clinical Oncology, 2014 Genitourinary Cancers Symposium (January 30 - February 1, 2014). Vol. 32, No 4_suppl (February 1 Supplement), 2014: 427
- Burotto M, Edgerly M, Velarde M, Balasubramaniam S, Drabkin H, Gormaz JG, O'Sullivan C, Madan R, Fojo T. A Phase II Multi-Center Study of Bevacizumab in Combination with Ixabepilone in Subjects with Advanced Renal Cell Carcinoma. Oncologist. 2017 Aug;22(8):888-e84. doi: 10.1634/theoncologist.2017-0211. Epub 2017 Jul 5.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Carcinoma
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Bevacizumab
Other Study ID Numbers
- 090057
- 09-C-0057
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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