Know Cancer

or
forgot password

Phase I Study of Combination of Nab-paclitaxel, Gemcitabine, and Bevacizumab in Advanced Malignancies


Phase 1
N/A
N/A
Open (Enrolling)
Both
Advanced Cancer

Thank you

Trial Information

Phase I Study of Combination of Nab-paclitaxel, Gemcitabine, and Bevacizumab in Advanced Malignancies


The Study Drugs:

Gemcitabine is designed to disrupt the growth of cancer cells, which may cause cancer cells
to die.

Bevacizumab is designed to block the growth of new blood vessels that feed the tumors.
This may prevent or slow down the growth of cancer cells.

Nab-paclitaxel is designed to block cancer cells from dividing, which may cause the cells to
die.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a dose
level of a combination of nab-paclitaxel, gemcitabine, and bevacizumab based on when you
joined this study. All participants will receive the same dose level of gemcitabine.
However, the first group of participants will receive the lowest dose level of
nab-paclitaxel and bevacizumab. Each new group will receive a higher dose for one of the
drugs than the group before it, if no intolerable side effects were seen. The other drug
may be at the same dose or a lower dose. This will continue until the highest tolerable dose
of combination of nab-paclitaxel, gemcitabine, and bevacizumab is found. Up to 15 dose
levels of the study drug combination will be tested. Three (3) to 4 participants will be
enrolled at each dose level.

Once the highest tolerated dose is found, up to 10 more participants will be added at that
dose level. This is called an expansion group.

Study Drug Administration:

On Days 1, 8, and 15 of each 28-day cycle, you will receive nab-paclitaxel and gemcitabine
by vein over about 90 minutes total. Also, if the first dose is well tolerated, you may be
given the remaining doses of nab-paclitaxel and gemcitabine at home.

On Days 1 and 15 of each cycle, you will receive bevacizumab by vein over about 60 minutes.
Also, if the first dose is well tolerated, you may be given the remaining doses of
bevacizumab at home.

Study Visits:

Each week during Cycle 1:

- Your medical history will be recorded.

- Blood (about 2 teaspoons) and urine will be collected for routine tests.

- Blood (about 2-5 teaspoons) will be drawn to test for fat levels in the blood. You
will need to fast for at least 4 hours before this blood draw.

- Your performance status will be recorded.

- You will be asked about any drugs you may be taking and if you had any side effects
from them.

- You will have urine tests performed to check for high levels of protein in your urine
(a known side effect of bevacizumab).

On Day 1 and 8 of Cycle 1, you will have a physical exam, including measurement of your
weight and vital signs.

During Week 1 of Cycles 2 and beyond:

- Your medical history will be recorded.

- You will have a physical exam, including measurement of your weight and vital signs.

- Blood (about 2 teaspoons) and urine will be collected for routine tests.

- Blood (about 2-5 teaspoons) will be drawn to test for fat levels in the blood. You
will need to fast for at least 4 hours before this blood draw.

- Blood (about 2 teaspoons) will be drawn to see how well your blood clots and how long
it takes for your blood to clot.

- Your performance status will be recorded.

- You will be asked about any drugs you may be taking and if you had any side effects
from them.

- Females who are able to become pregnant must have a negative blood (about 1 teaspoon)
pregnancy test.

During Weeks 2 and 4 of Cycles 2 and beyond:

- Your performance status will be recorded.

- You will be asked about any drugs you may be taking and if you had any side effects
from them.

- Blood (about 2 teaspoons) will be collected for routine tests.

During Week 3 of Cycles 2 and beyond:

- Your medical history will be recorded.

- You will have a physical exam, including measurement of your weight and vital signs

- Blood (about 2 teaspoons) and urine will be collected for routine tests.

- Blood (about 2-5 teaspoons) will be drawn to test for fat levels in the blood. You
will need to fast for at least 4 hours before this blood draw.

- Blood (about 2 teaspoons) will be drawn to see how well your blood clots and how long
it takes for your blood to clot.

- Your performance status will be recorded.

- You will be asked about any drugs you may be taking and if you had any side effects
from them.

At the end of every 2 cycles (Cycles 2, 4, 6, and so on), you will have an x-ray, CT scan,
PET scan, or MRI scan to check the status of the disease. If you have disease in your
bones, a bone scan may also be done.

Length of Study:

You may continue taking the study drugs for as long as the doctor thinks it is in your best
interest. You will no longer be able to take the study drugs if the disease gets worse or
intolerable side effects occur.

You may chose to stop taking the study drugs at any time. You should tell the study doctor
right away if you are thinking about stopping your participation in this study. The study
doctor will talk to you about how to safely stop taking the study drugs.

This is an investigational study. Gemcitabine is FDA approved and commercially available
for the treatment of certain types of breast cancer, non-small cell lung cancer, pancreatic
cancer, and ovarian cancer. Bevacizumab is FDA approved and commercially available for the
treatment of colorectal, breast, lung, and brain cancer. Nab-paclitaxel is FDA approved and
commercially available for the treatment of breast cancer. The combination of these drugs is
investigational.

Up to 120 patients will take part in this study, but this may be increased at a later time.
All will be enrolled at MD Anderson.


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 complete
response (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. The Eastern Cooperative Oncology Group (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 of normal (ULN); total bilirubin 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 cerebrovascular accident (CVA) within 6 months

10. History of surgery within last 28 days.

11. Grade 3/4 proteinuria

12. Nephrotic syndrome

13. Incompletely healed wound.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD)

Outcome Description:

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.

Outcome Time Frame:

With each 28 day cycle

Safety Issue:

Yes

Principal Investigator

David S. Hong, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2009-0855

NCT ID:

NCT01113476

Start Date:

April 2010

Completion Date:

Related Keywords:

  • Advanced Cancer
  • Advanced Malignancies
  • Nab-paclitaxel
  • Gemcitabine
  • Bevacizumab
  • Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030