Bevacizumab Plus Ixabepilone to Treat Patients With Advanced Kidney Cancer
NCT ID: NCT00923130
Last Updated: 2018-04-17
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
30 participants
Study Classification
INTERVENTIONAL
Study Start Date
2009-01-07
Study Completion Date
2016-06-30
Brief Summary
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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.
* 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.
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Detailed Description
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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.
* 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.
Conditions
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Renal Cell Carcinoma
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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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
Group Type
EXPERIMENTAL
Bevacizumab
Intervention Type
DRUG
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.
Ixabepilone
Intervention Type
DRUG
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.
Interventions
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Bevacizumab
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.
Intervention Type
DRUG
Ixabepilone
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.
Intervention Type
DRUG
Other Intervention Names
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Avastin
Ixempra
Eligibility Criteria
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Inclusion Criteria
Subjects meeting all of the following criteria will be considered for enrollment into the study:
1. 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..
2. 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.
3. Eighteen years of age or older.
4. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
5. 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.
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
7. 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.
8. 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).
9. Subjects must agree to sign and date an Institutional Review Board (IRB)-approved subject informed consent form.
10. Subjects must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
11. Patients must have measurable disease either by conventional imaging or clinical examination.
1. 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..
2. 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.
3. Eighteen years of age or older.
4. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
5. 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.
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
7. 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.
8. 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).
9. Subjects must agree to sign and date an Institutional Review Board (IRB)-approved subject informed consent form.
10. Subjects must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
11. 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:
1. 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)
2. Cumulative radiation therapy to greater than 25% of the total bone marrow.
3. 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.
4. 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.
5. Symptomatic spinal cord compression.
6. Evidence of clinically significant bleeding diathesis or underlying coagulopathy.
7. Antiretroviral therapy for human immunodeficiency virus (HIV) disease.
8. 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.
9. 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.
10. Prior therapy with bevacizumab
11. Prior therapy with ixabepilone.
12. Patients on anticoagulant therapy will be evaluated on a case by case basis for inclusion.
13. Serious or non-healing wound, ulcer or bone fracture
14. History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to day 1
15. Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1
16. 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.
17. Patients with known hypersensitivity of Chinese hamster ovary cell products or other recombinant human antibodies
18. Patients receiving cytochrome P450 3A4 (CYP3A4) inhibitors in section 3.6 that cannot be discontinued.
1. 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)
2. Cumulative radiation therapy to greater than 25% of the total bone marrow.
3. 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.
4. 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.
5. Symptomatic spinal cord compression.
6. Evidence of clinically significant bleeding diathesis or underlying coagulopathy.
7. Antiretroviral therapy for human immunodeficiency virus (HIV) disease.
8. 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.
9. 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.
10. Prior therapy with bevacizumab
11. Prior therapy with ixabepilone.
12. Patients on anticoagulant therapy will be evaluated on a case by case basis for inclusion.
13. Serious or non-healing wound, ulcer or bone fracture
14. History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to day 1
15. Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1
16. 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.
17. Patients with known hypersensitivity of Chinese hamster ovary cell products or other recombinant human antibodies
18. Patients receiving cytochrome P450 3A4 (CYP3A4) inhibitors in section 3.6 that cannot be discontinued.
Minimum Eligible Age
18 Years
Maximum Eligible Age
99 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Cancer Institute (NCI)
NIH
Sponsor Role
lead
Responsible Party
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Ravi A. Madan, M.D.
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Ravi A Madan, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)
Locations
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National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
Site Status
University of South Carolina
Charleston, South Carolina, United States
Site Status
Countries
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United States
References
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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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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
Reference Type
RESULT
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.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol
Related Links
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http://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2009-C-0057.html
NIH Clinical Center Detailed Web Page
Other Identifiers
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09-C-0057
Identifier Type: -
Identifier Source: secondary_id
090057
Identifier Type: -
Identifier Source: org_study_id
NCT00820209
Identifier Type: -
Identifier Source: nct_alias
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PHASE1
A Phase II Study of Bevacizumab and Erlotinib in Subjects With Advanced Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) or Sporadic Papillary Renal Cell Cancer
NCT01130519
COMPLETED
PHASE2
Bevacizumab in Treating Patients With Unresectable or Metastatic Kidney Cancer
NCT00601926
TERMINATED
PHASE2
Bevacizumab (Avastin) and RAD001(Everolimus)in the Treatment of Advanced Clear Cell Renal Carcinoma
NCT00323739
COMPLETED
PHASE2
CRLX101 Plus Bevacizumab in Advanced RCC
NCT01625936
COMPLETED
PHASE1
Sorafenib Tosylate and Bevacizumab in Treating Patients With Advanced Kidney Cancer
NCT00126503
COMPLETED
PHASE1/PHASE2
Nivolumab With or Without Bevacizumab or Ipilimumab Before Surgery in Treating Patients With Metastatic Kidney Cancer That Can Be Removed by Surgery
NCT02210117
ACTIVE_NOT_RECRUITING
EARLY_PHASE1
Monoclonal Antibody Therapy in Treating Patients With Advanced Kidney Cancer
NCT00019539
COMPLETED
PHASE2
A Study to Evaluate the Effectiveness of 5-Azacitidine and Bevacizumab in Advanced Renal Cell Carcinoma
NCT00934440
TERMINATED
PHASE1/PHASE2
An Observational Study of Avastin (Bevacizumab) in Combination With Interferon Alpha-2a as First-Line Treatment in Patients With Advanced and/or Metastatic Renal Cell Carcinoma
NCT01351571
COMPLETED
Study Comparing Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa In Advanced Renal Cell Carcinoma Subjects
NCT00631371
COMPLETED
PHASE3
A Study of Bempegaldesleukin (NKTR-214: BEMPEG) in Combination With Nivolumab Compared With the Investigator's Choice of a Tyrosine Kinase Inhibitor (TKI) Therapy (Either Sunitinib or Cabozantinib Monotherapy) for Advanced Metastatic Renal Cell Carcinoma (RCC)
NCT03729245
TERMINATED
PHASE3
Treatment of Refractory Metastatic Renal Cell Carcinoma With Bevacizumab and RAD001 (Everolimus)
NCT00651482
TERMINATED
PHASE2
Safety and Efficacy of Bevacizumab Plus RAD001 Versus Interferon Alfa-2a and Bevacizumab for the First-line Treatment in Adult Patients With Kidney Cancer
NCT00719264
COMPLETED
PHASE2
A Study of Atezolizumab (an Engineered Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) as Monotherapy or in Combination With Bevacizumab (Avastin®) Compared to Sunitinib (Sutent®) in Participants With Untreated Advanced Renal Cell Carcinoma
NCT01984242
COMPLETED
PHASE2
Bevacizumab, Sorafenib Tosylate, and Temsirolimus in Treating Patients With Metastatic Kidney Cancer
NCT00378703
COMPLETED
PHASE2
VEGF Imaging in Renal Cell Carcinoma
NCT00831857
COMPLETED