Status:
COMPLETED
Avastin and Temsirolimus Following Tyrosine Kinase Inhibitor Failure in Patients With Advanced Renal Cell Carcinoma
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Genentech, Inc.
Dana-Farber Cancer Institute
Conditions:
Renal Cell Carcinoma
Kidney Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a single-arm phase II trial evaluating the combination of avastin and temsirolimus in patients with metastatic renal cell cancer (RCC) including both histologically confirmed clear cell (cc) o...
Detailed Description
Avastin, a humanized IgG1 monoclonal antibody (MAb), inhibits vascular endothelial growth factor (VEGF). VEGF is one of the most potent and specific proangiogenic factors and has been identified as a ...
Eligibility Criteria
Inclusion
- Histologically confirmed renal cell carcinoma in either primary or metastatic lesions. Non-clear histology will be allowed.
- Disease progression on a VEGF-targeted tyrosine kinase inhibitor as the most recent therapy or have experienced intolerable toxicity so as require discontinuation. Only one prior VEGF-targeted tyrosine kinase inhibitor.
- Must be off of VEGF-targeted tyrosine kinase inhibitor for 2 weeks or greater.
- One measurable lesion which is not curable by standard radiation therapy or surgery.
- The enrolling site must agree to obtain paraffin-embedded tumor blocks or at least 10 unstained, paraffin-embedded slides for submission for correlative studies.
- 18 years of age or older
- ECOG Performance Status of 0 or 1
- Baseline laboratory values as outlined in the protocol
- Life expectancy of greater than 3 months
- No prior malignancy diagnosed within the past three years, other than superficial basal cell and superficial squamous cell, or carcinoma in situ of the cervix.
Exclusion
- Known CNS disease, except for treated brain metastases
- Previously treated with avastin or mTOR inhibitors
- Other then VEFG-targeted TKI, patients may only have had prior immunotherapy or chemotherapy for stage IV disease
- History of allergic reaction to Chinese hamster ovary cell products, other recombinant antibodies, or compounds of similar chemical or biologic composition to avastin or temsirolimus
- History of bleeding diathesis or coagulopathy. Therapeutic anticoagulants are allowed
- Patients with clinically significant cardiovascular disease
- Patients receiving enzyme-inducing antiepileptic drugs or any other CYP3A4 inducer such as rifampin or St. John's wort
- No serious non-healing wound, ulcer or bone fracture
- No uncontrolled intercurrent illness including , but not limited to, ongoing active infection requiring parental antibiotics or psychiatric illness/social situations that would limit compliance with study requirements
- HIV-positive receiving combination anti-retroviral therapy
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study
- Core biopsy or other minor surgical procedure, excluding placement of vascular access device, within 7 days prior to enrollment on study
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
- Known hypersensitivity to any component of avastin or temsirolimus
- Life expectancy of less than 12 weeks
- History of hemoptysis within 1 month prior to day 1
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00782275
Start Date
April 1 2009
End Date
May 1 2015
Last Update
January 24 2018
Active Locations (3)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
3
Vanderbilt Univeristy Medical Center
Nashville, Tennessee, United States, 37232