Dasatinib, Bevacizumab, Paclitaxel in Patients With Advanced Malignancies
This study is currently recruiting participants.
Verified March 2014 by M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
First received: November 17, 2009
Last updated: March 5, 2014
Last verified: March 2014
The goal of this clinical research study is to find the highest tolerable dose of the combination of dasatinib, bevacizumab, and paclitaxel with or without Methylnaltrexone 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
||A Phase I Trial of Dasatinib (Src Inhibitor), Bevacizumab (Anti-VEGF Monoclonal Antibody) and Metronomic Paclitaxel in Patients With Advanced Malignancies
Primary Outcome Measures:
- Maximum Tolerated Dose (MTD) [ Time Frame: Continous assessment during each dose level/28-day cycle ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||November 2015 (Final data collection date for primary outcome measure)
Experimental: Dasatinib, Bevacizumab + Paclitaxel
Starting dose levels: 50 mg Dasatinib daily by mouth (PO), 5 mg/kg Bevacizumab IV on Day 1 and 15; Paclitaxel 40 mg/m2 IV on Day 1, 8 and 15
Starting dose of 50 mg daily PO for 28 day cycle
Starting dose 5 mg/kg IV Day 1 and 15
- Anti-VEGF monoclonal antibody
Starting dose 40 mg/m2 IV Day 1, 8 and 15
Other Name: Taxol
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Patients with advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or who have no standard therapy available that improves survival by at least three months.
- Patients must be >/= 3 weeks beyond treatment with a cytotoxic chemotherapy regimen, or therapeutic radiation, or major surgery. Patients may have received palliative localized radiation immediately before or during treatment providing radiation is not delivered to the only site of disease being treated under this protocol. After targeted/biologic therapy a patient has to be off treatment for 5 half-lives or 3 weeks whatever is shorter.
- ECOG performance status </= 2.
- Patients must have normal organ and marrow function defined as: absolute neutrophil count >/= 1,000/mL; platelets >/=90,000/mL; creatinine </= 2 X ULN; total bilirubin </= 2.0; ALT(SGPT) </= 5 X ULN; Exception for patients with liver metastasis: total bilirubin </= 3 x ULN; ALT(SGPT) </= 8 X ULN.
- 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 30 days after the last dose.
- Patients must be able to understand and be willing to sign a written informed consent document.
- Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, need for ventilatory support.
- Patients with hemoptysis within 28 days prior to entering the study.
- Patients with clinically significant unexplained bleeding within 28 days prior to the first dose of study medication.
- Uncontrolled systemic vascular hypertension (systolic blood pressure > 140mmHg, diastolic blood pressure > 90mmHg on medication).
- Patients with clinically significant cardiovascular disease: history of CVA within 6 months; myocardial infarction or unstable angina within 6 months.
- Major surgery within 28 days prior to Day 1 of dosing Bevacizumab.
- Pregnant or lactating women.
- History of hypersensitivity to dasatinib or any component of the formulation.
- History of hypersensitivity to bevacizumab, murine products, or any component of the formulation.
- History of hypersensitivity to paclitaxel or any component of the formulation.
- Patients with pleural effusion which is considered clinically significant by the attending physician.
- Patients unwilling or unable to sign informed consent document.
- Social situations that would limit compliance with study requirements.
- Patients receiving opioids within 2 weeks before signing the consent and patients, who cannot be off opioids until initiating the study medication (for methylnaltrexone arm only).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01015222
|Contact: Filip Janku, MD,PHD
|UT MD Anderson Cancer Center
|Houston, Texas, United States, 77030 |
M.D. Anderson Cancer Center
||Filip Janku, MD,PHD
||UT MD Anderson Cancer Center
No publications provided
||M.D. Anderson Cancer Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 17, 2009
||March 5, 2014
||United States: Institutional Review Board
Keywords provided by M.D. Anderson Cancer Center:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 09, 2014
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Angiogenesis Modulating Agents
Protein Kinase Inhibitors