Bevacizumab and Temsirolimus in Patients With Advanced Malignancy
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00610493
First received: January 25, 2008
Last updated: December 13, 2012
Last verified: December 2012
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Purpose
The goal of this clinical research study is to find the highest tolerable dose of Avastin (bevacizumab) and Torisel (temsirolimus) that can be given, in combination, to patients with advanced cancer that has spread or is unable to be surgically removed. The safety of this drug combination will also be studied.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Cancer |
Drug: Bevacizumab Drug: Temsirolimus Procedure: Additional Blood Drawn Procedure: Biopsy Procedure: DCE-MRI Scan |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Trial of Bevacizumab and Temsirolimus in Patients With Advanced Malignancy |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Maximum tolerated doses (MTDs) + Dose-limiting toxicities (DLTs) [ Time Frame: Continuous assessment throughout and determination of dose-limiting toxicities with 21 Day Cycle ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 183 |
| Study Start Date: | January 2008 |
| Estimated Primary Completion Date: | January 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Bevacizumab + Temsirolimus
Bevacizumab 5 mg/kg By Vein Over 90 Minutes on Day 1 of Each 21 Day Cycle. Temsirolimus 5 mg By Vein Over 30-60 Minutes on Days 1, 8, 15 of Each 21 Day Cycle. First tumor biopsy during screening visit and Second at the end of Cycle 1. DCE-MRI (dynamic contrast-enhanced magnetic resonance imaging) scan during screening visit, at 24-48 hours after the start of Cycle 1, and at the end of Cycle 1.
|
Drug: Bevacizumab
5 mg/kg By Vein Over 90 Minutes on Day 1 of Each 21 Day Cycle
Other Names:
Drug: Temsirolimus
5 mg By Vein Over 30-60 Minutes on Days 1, 8, 15 of Each 21 Day Cycle
Other Names:
Procedure: Additional Blood Drawn
2 teaspoons each time: 4xDay Cycle 1 after start of first infusion; at Day 8 of Cycle 1; at Day 15 of Cycle 1; and at end of Cycle 1.
Procedure: Biopsy
First tumor biopsy during screening visit and Second at the end of Cycle 1
Procedure: DCE-MRI Scan
DCE-MRI (dynamic contrast-enhanced magnetic resonance imaging) scan during screening visit, at 24-48 hours after the start of Cycle 1, and at the end of Cycle 1
Other Names:
|
Show Detailed Description
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that induces a CR rate of at least 10% or improves survival by at least three months.
- Patients should be at least four weeks from the last day of therapeutic radiation or cytotoxic chemotherapy or from antibody therapy, or at least five half-lives from non-cytotoxic targeted or biologic therapy. Patients may have received palliative radiation immediately before (or during) treatment provided radiation is not to the only target lesion available.
- ECOG performance status </= 2 (Karnofsky >/= 60%).
- Patients must have allowable organ and marrow function defined as: absolute neutrophil count >/= 1,000/mL; platelets >/=50,000/mL; creatinine </= 3 X ULN; total bilirubin </= 3.0; AST(SGOT)/ALT(SGPT) </= 5 X ULN; fasting level of total cholesterol of no more than 350mg/dL; triglyceride level of no more than 400mg/dL.
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days after the last dose.
- Ability to understand and the willingness to sign a written informed consent document
- Patients may not be receiving any other investigational agents and/or any other concurrent anticancer agents or therapies.
Exclusion Criteria:
- Patients with hemoptysis within 28 days prior to entering the study.
- Patients with clinically significant unexplained bleeding within 28 days prior to entering the study
- Uncontrolled systemic vascular hypertension (Systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg on medication).
- Patients with clinically significant cardiovascular disease: - History of CVA within 6 months - Myocardial infarction or unstable angina within 6 months - Unstable angina pectoris
- Pregnant or lactating women.
- History of hypersensitivity to bevacizumab, murine products, or any component of the formulation.
- History of hypersensitivity to Temsirolimus or its metabolites (including sirolimus), polysorbate 80, or to any component of the formulation
- Patients that are taking CYP3A4 inducers and/or inhibitors. Please see section 3.2 in the protocol for details. If a patient has a history of taking CYP3A4 inducers and/or inhibitors prior to enrollment on the protocol, it is strongly recommended that the patient stops the drug and waits at least 5 half-lives of said drug before initiating therapy on protocol.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00610493
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Razelle Kurzrock, MD | M.D. Anderson Cancer Center |
| Study Chair: | Sarina Piha-Paul, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00610493 History of Changes |
| Other Study ID Numbers: | 2007-0668 |
| Study First Received: | January 25, 2008 |
| Last Updated: | December 13, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Advanced Cancer Bevacizumab Temsirolimus Avastin Torisel CCI-779 |
Anti-VEGF monoclonal antibody rhuMAb-VEGF dynamic contrast-enhanced magnetic resonance imaging DCE magnetic resonance imaging MRI |
Additional relevant MeSH terms:
|
Neoplasms Antibodies Antibodies, Monoclonal Sirolimus Everolimus Bevacizumab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic |
Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Anti-Bacterial Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013