Overview

Nab-paclitaxel, Gemcitabine, and Bevacizumab in Advanced Malignancies

Status:
Unknown status
Trial end date:
2021-04-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Treatments:
Albumin-Bound Paclitaxel
Bevacizumab
Gemcitabine
Paclitaxel
Criteria
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 /= 60%).

4. Patients must have allowable organ and marrow function defined as: absolute neutrophil
count >/= 1,000/mL; platelets >/=50,000/mL; creatinine 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.