Nab-paclitaxel, Gemcitabine, and Bevacizumab in Advanced Malignancies
This study is currently recruiting participants.
Verified December 2012 by M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
First received: April 28, 2010
Last updated: December 27, 2012
Last verified: December 2012
The goal of this clinical research study is to find the highest tolerable dose of the combination of Abraxane (nab-paclitaxel), Gemzar (gemcitabine), and Avastin (bevacizumab) that can be given to patients with advanced cancer. The safety of this drug combination will also be studied.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase I Study of Combination of Nab-paclitaxel, Gemcitabine, and Bevacizumab in Advanced Malignancies
Primary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||April 2015 (Final data collection date for primary outcome measure)
Experimental: Nab-paclitaxel, Gemcitabine + Bevacizumab
Starting doses of Nab-paclitaxel 50 mg/m^2, Bevacizumab 5 mg/kg + fixed dose of Gemcitabine 1000 mg/m^2
Starting dose of 50 mg/m^2 on Day 1, 8 + 15 every 28 days (+/- 2 days)
Starting dose of 5 mg/m^2 on Day 1 + 15 every 28 days (+/- 2 days)
- Anti-VEGF monoclonal antibody
1000 mg/kg Day 1, 8 + 15 every 28 days (+/- 2 days)
- Gemcitabine Hydrochloride
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that induces a complete response (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.
- The Eastern Cooperative Oncology Group (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 * upper limit of normal (ULN); total bilirubin </= 3.0; ALT(SGPT) </= 5 * 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.
- 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 > 140mmHg, diastolic blood pressure > 90 mmHg on medication).
- Pregnant or lactating women.
- History of hypersensitivity to bevacizumab, murine products, or any component of the formulation.
- History of hypersensitivity to gemcitabine
- History of hypersensitivity to nab-paclitaxel or paclitaxel
- Patients with clinically significant cardiovascular disease: Myocardial Infarction or unstable angina pectoris within the last 6 months, Class III/IV NYHA heart failure
- History of cerebrovascular accident (CVA) within 6 months
- History of surgery within last 28 days.
- Grade 3/4 proteinuria
- Nephrotic syndrome
- Incompletely healed wound.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01113476
|Contact: David S. Hong, MD
|UT MD Anderson Cancer Center
|Houston, Texas, United States, 77030 |
|Principal Investigator: David S. Hong, MD |
M.D. Anderson Cancer Center
||David S. Hong, MD
||UT MD Anderson Cancer Center
No publications provided
||M.D. Anderson Cancer Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 28, 2010
||December 27, 2012
||United States: Institutional Review Board
Keywords provided by M.D. Anderson Cancer Center:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on June 17, 2013
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Angiogenesis Modulating Agents