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Dasatinib, Bevacizumab, Paclitaxel in Patients With Advanced Malignancies

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01015222
First received: November 17, 2009
Last updated: October 24, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Advanced Cancer
Drug: Dasatinib
Drug: Bevacizumab
Drug: Paclitaxel
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 Dasatinib (Src Inhibitor), Bevacizumab (Anti-VEGF Monoclonal Antibody) and Metronomic Paclitaxel in Patients With Advanced Malignancies

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) of Dasatinib, Bevacizumab and Paclitaxel + or - Methylnaltrexone [ Time Frame: Continous assessment during each dose level/28-day cycle ] [ Designated as safety issue: Yes ]
    MTD defined as the highest dose below any dose that has one third or more patients with dose limiting toxicities (DLT).


Estimated Enrollment: 218
Study Start Date: November 2009
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Dasatinib
Starting dose of 50 mg daily PO for 28 day cycle
Other Names:
  • BMS-354825
  • Sprycel
Drug: Bevacizumab
Starting dose 5 mg/kg IV Day 1 and 15
Other Names:
  • Avastin
  • Anti-VEGF monoclonal antibody
  • rhuMAb-VEGF
Drug: Paclitaxel
Starting dose 40 mg/m2 IV Day 1, 8 and 15
Other Name: Taxol

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. 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.
  3. ECOG performance status </= 2.
  4. 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.
  5. 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.
  6. Patients must be able to understand and be willing to sign a written informed consent document.

Exclusion Criteria:

  1. Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, need for ventilatory support.
  2. Patients with hemoptysis within 28 days prior to entering the study.
  3. Patients with clinically significant unexplained bleeding within 28 days prior to the first dose of study medication.
  4. Uncontrolled systemic vascular hypertension (systolic blood pressure > 140mmHg, diastolic blood pressure > 90mmHg on medication).
  5. Patients with clinically significant cardiovascular disease: history of CVA within 6 months; myocardial infarction or unstable angina within 6 months.
  6. Major surgery within 28 days prior to Day 1 of dosing Bevacizumab.
  7. Pregnant or lactating women.
  8. History of hypersensitivity to dasatinib or any component of the formulation.
  9. History of hypersensitivity to bevacizumab, murine products, or any component of the formulation.
  10. History of hypersensitivity to paclitaxel or any component of the formulation.
  11. Patients with pleural effusion which is considered clinically significant by the attending physician.
  12. Patients unwilling or unable to sign informed consent document.
  13. Social situations that would limit compliance with study requirements.
  14. 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01015222

Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Filip Janku, MD,PHD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01015222     History of Changes
Other Study ID Numbers: 2009-0521, NCI-2012-01274
Study First Received: November 17, 2009
Last Updated: October 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Advanced Malignancies
Metastatic cancer
Bevacizumab
Avastin
Dasatinib
Sprycel
Paclitaxel
Taxol

Additional relevant MeSH terms:
Neoplasms
Antibodies, Monoclonal
Bevacizumab
Dasatinib
Paclitaxel
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Growth Inhibitors
Growth Substances
Immunologic Factors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protein Kinase Inhibitors
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 25, 2014