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A Phase I Study of Bendamustine and Bevacizumab for Patients With Advanced Cancers


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

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Trial Information

A Phase I Study of Bendamustine and Bevacizumab for Patients With Advanced Cancers


The Study Drugs:

Bendamustine is designed to damage DNA (the genetic material) of cancer cells. Bendamustine
also interferes with the creation of new DNA, which may keep cancer cells from repairing
themselves or forming new cancer cells.

Bevacizumab is designed to block the growth of blood vessels that supply the nutrients
needed for tumor growth, which may prevent or slow down the growth of cancer cells.
Bevacizumab is no longer FDA approved to treat breast cancer.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a dose
level of bendamustine based on when you join this study. Up to 4 dose levels of
bendamustine will be tested. Up to 3 participants will be enrolled at each dose level. The
first group of participants will receive the lowest dose level. Each new group will receive
a higher dose than the group before it, if no intolerable side effects were seen. This will
continue until the highest tolerable dose of bendamustine is found.

All participants will receive the same dose level of bevacizumab.

Study Drug Administration:

You will receive bendamustine by vein over 30-60 minutes on Days 1 and 2 of each 28-day
study cycle.

You will receive bevacizumab by vein on Days 1 and 15 of each cycle. The first time you
receive bevacizumab, it will be given over 90 minutes. If you tolerate it well, the rest of
the doses will be given over 30-60 minutes.

Study Visits:

On Day 1 of each cycle:

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

- Blood (about 1 tablespoon ) will be drawn for routine tests.

- Women who are able to become pregnant will have a urine pregnancy test.

Every 2 cycles (Cycles 2, 4, 6, and so on):

- Blood (about 1 tablespoon) will be drawn to test for tumor markers.

- A chest x-ray, CT scan, MRI scan, PET scan, and/or PET/CT scan will be performed to
check the status of the disease. These scans will also be performed at any time that
the doctor thinks it is needed to check the status of the disease. If the study doctor
thinks it is in your best interest, other types of scans that have not been listed here
may also be performed.

Length of Study:

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

Follow-Up Visit:

Six (6) weeks after you stop taking the study drug combination for any reason, the following
tests and procedures will be performed:

- You will have a physical exam.

- Your performance status will be recorded.

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

- If the study doctor thinks it is needed, a chest x-ray, CT scan, MRI scan, PET scan
and/or PET/CT scan will be performed to check the status of the disease. If the study
doctor thinks it is in your best interest, other types of scans that have not been
listed here may also be performed.

This is an investigational study. Bendamustine is FDA approved and commercially available
for the treatment of chronic lymphoid leukemia and non-Hodgkin's lymphoma. Bevacizumab is
FDA approved and commercially available for the treatment of metastatic colorectal cancer,
non-small-cell lung cancer (NSCLC), and a type of brain cancer called glioblastoma
multiforme. The use of these drugs in combination in advanced cancer is investigational.

Up to 55 participants will take part in this study. All will be enrolled at M. D. Anderson.


Inclusion Criteria:



1. Patients must have histologically confirmed cancer.

2. Patients should be refractory to standard therapy, relapsed after standard therapy,
or have no standard therapy that increases survival by at least 3 months.

3. Performance status Eastern Cooperative Oncology Group (ECOG) 0-2 (capable of all self
care but unable to carry out any work activities). Pediatric: performance status
Karnovsky (>10) or Lansky (<10).

4. Adequate renal function (serum creatinine Filtration Rate (GFR) >/= 40 mL/min if creatinine > 2.0 mg/dL). Pediatric: serum
creatinine
5. Hepatic function: total bilirubin must have a total bilirubin patient has liver metastases, total bilirubin limit of normal.

6. Adequate bone marrow function (Absolute neutrophil count (ANC) >/= 1,000 cells/uL;
Platelets (PLT) >/= 75,000 cells/uL), unless these abnormalities are due to bone
marrow involvement.

7. At least three weeks from previous cytotoxic chemotherapy. After targeted or biologic
therapy there should be 5 half-lives or 3 weeks, whichever is shorter.

8. All females in childbearing age MUST have a negative urine HCG test unless prior
hysterectomy or menopause (defined as age above 55 and six months without menstrual
activity). Patients should not become pregnant or breast-feed while on this study.
Sexually active patients should use effective birth control.

9. Must be >/= 13 years of age.

10. Sign informed consent. Pediatric participants: age 13-17 would sign assent, parent or
guardian would sign consent.

Exclusion Criteria:

1. Pregnant females.

2. Inability to complete informed consent process and adhere to protocol treatment plan
and follow-up requirements.

3. Serious or non-healing wound, ulcer or bone fracture.

4. Uncontrolled systemic vascular hypertension (systolic blood pressure > 140 mm Hg,
diastolic blood pressure > 90 mm Hg).

5. Uncontrolled intercurrent illness, including, but not limited to, ongoing or active
infection requiring parental antibiotics, or psychiatric illness/social situations
that would limit compliance with study requirements.

6. History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess
within 28 days.

7. Patients with clinical bleeding, active gastric or duodenal ulcer.

8. Patients with history of bleeding (central nervous system) CNS metastasis will be
excluded from the trial.

9. Patients with major surgery within 28 days prior to entering the study.

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 Time Frame:

Every 28 days

Safety Issue:

Yes

Principal Investigator

Apostolia M. Tsimberidou, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2009-0979

NCT ID:

NCT01152203

Start Date:

June 2010

Completion Date:

Related Keywords:

  • Advanced Cancer
  • Bendamustine
  • Bevacizumab
  • Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030