Nab-paclitaxel, Gemcitabine, and Bevacizumab in Advanced Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01113476
Recruitment Status : Active, not recruiting
First Posted : April 30, 2010
Last Update Posted : March 2, 2018
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Cancer Drug: Nab-paclitaxel Drug: Bevacizumab Drug: Gemcitabine Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Combination of Nab-paclitaxel, Gemcitabine, and Bevacizumab in Advanced Malignancies
Actual Study Start Date : April 27, 2010
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
Drug: Nab-paclitaxel
Starting dose of 50 mg/m^2 on Day 1, 8 + 15 every 28 days (+/- 2 days)
Other Names:
  • Paclitaxel
  • Abraxane
  • ABI-007

Drug: Bevacizumab
Starting dose of 5 mg/m^2 on Day 1 + 15 every 28 days (+/- 2 days)
Other Names:
  • Avastin
  • Anti-VEGF monoclonal antibody
  • rhuMAb-VEGF

Drug: Gemcitabine
1000 mg/kg Day 1, 8 + 15 every 28 days (+/- 2 days)
Other Names:
  • Gemcitabine Hydrochloride
  • Gemzar

Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of Gemcitabine, Nab-Paclitaxel and Bevacizumab [ Time Frame: With each 28 day cycle ]
    A MTD is defined as the dose level below the dose at which 2 of 6 patients experience drug-related dose limiting toxicity (DLT) in the first cycle. DLT defined as any grade 3 or 4 non-hematologic toxicity as defined in the NCI CTC v4.0, even if expected and believed related to study medications (except nausea and vomiting responsive to appropriate regimens or alopecia), any Grade 4 hematologic toxicity lasting 2 weeks or longer (as defined by the NCI-CTCAE), despite supportive care; any Grade 4 nausea or vomiting > 5 days despite maximum anti-nausea regimens, and any other Grade 3 non-hematologic toxicity including symptoms/signs of vascular leak or cytokine release syndrome; or any severe or life-threatening complication or abnormality not defined in the NCI-CTCAE v.4.0 that is attributable to therapy.

Secondary Outcome Measures :
  1. Response Rate [ Time Frame: After 2, 28 day cycles ]
    Patients with lymphoma measured per WHO criteria, all others evaluated with RECIST (version 1.1) criteria. Measurable disease defined as at least one lesion that can be accurately measured in at least one dimension. Best Response: Measurement of longest dimension of each lesion size is required for follow-up. Complete Response (CR): Disappearance of all target and non-target lesions and no evidence of new lesions documented by 2 disease assessments at least 4 weeks apart. Partial Response (PR): At least 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions, taking as reference baseline sum of LD. Stable Disease (SD): Stable disease defined as any condition not meeting above criteria. Progressive Disease (PD): At least a 20% increase in sum of LD of target lesions taking as reference smallest sum LD or appearance of new lesions after study entry.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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.
  2. 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.
  3. ECOG performance status </= 2 (Karnofsky >/= 60%).
  4. 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; ALT(SGPT) </= 5 X ULN; fasting level of total cholesterol of no more than 350mg/dL; triglyceride level of no more than 400mg/dL.
  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 90 days after the last dose.
  6. Ability to understand and the willingness to sign a written informed consent document.
  7. Patients may not be receiving any other investigational agents and/or any other concurrent anticancer agents or therapies.

Exclusion Criteria:

  1. Patients with hemoptysis within 28 days prior to entering the study.
  2. Patients with clinically significant unexplained bleeding within 28 days prior to entering the study.
  3. Uncontrolled systemic vascular hypertension (Systolic blood pressure > 140mmHg, diastolic blood pressure > 90 mmHg on medication).
  4. Pregnant or lactating women.
  5. History of hypersensitivity to bevacizumab, murine products, or any component of the formulation.
  6. History of hypersensitivity to gemcitabine.
  7. History of hypersensitivity to nab-paclitaxel or paclitaxel.
  8. Patients with clinically significant cardiovascular disease: Myocardial Infarction or unstable angina pectoris within the last 6 months, Class III/IV NYHA heart failure.
  9. History of CVA within 6 months.
  10. History of surgery within last 28 days.
  11. Grade 3/4 proteinuria.
  12. Nephrotic syndrome.
  13. Incompletely healed wound.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01113476

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Study Chair: David S. Hong, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01113476     History of Changes
Other Study ID Numbers: 2009-0855
NCI-2011-02061 ( Registry Identifier: NCI CTRP )
First Posted: April 30, 2010    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Advanced Malignancies

Additional relevant MeSH terms:
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors