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A Phase II Evaluation of Bevacizumab and Paclitaxel in Patients With Recurrent Small Cell, Large Cell, and Neuroendocrine Tumors of the Cervix and Uterus


Phase 2
N/A
N/A
Not Enrolling
Female
Cervical Cancer, Uterine Cancer

Thank you

Trial Information

A Phase II Evaluation of Bevacizumab and Paclitaxel in Patients With Recurrent Small Cell, Large Cell, and Neuroendocrine Tumors of the Cervix and Uterus


The Study Drugs:

Paclitaxel is designed to block the mechanisms of cell division in cancer cells, which may
cause them to die.

Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the
effects of Vascular endothelial growth factor (VEGF), a blood-vessel stimulating agent that
plays an important role in the growth of both normal and abnormal blood vessels.

Study Drug Administration:

If you are found to be eligible to take part in this study, on Days 1, 8, 15, and 22 of each
28-day study "cycle", you will receive paclitaxel through a needle into your vein over 1
hour.

On Days 1 and 15 of each cycle, you will receive bevacizumab by vein. The first dose of
bevacizumab will be given over about 90 minutes. If the first dose is well tolerated, the
second dose may be given over about 60 minutes. If this is well tolerated, the third and any
other doses may be given over about 30 minutes.

Before you receive the study drugs, you will receive premedication (selected by your doctor)
to help prevent or lessen any side effects from the study drugs.

Study Visits:

About every 4 weeks, the following tests and procedures will be performed:

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

- You will have a performance status evaluation.

- Blood (about 2-3 teaspoons) will be drawn for routine tests and to test how your blood
clots.

- You will be asked if you have experienced any side effects.

About every 8 weeks, you will have a chest x-ray and a computed tomography (CT) or magnetic
resonance imaging (MRI) scan of your abdomen and pelvis to check the status of the disease.

Length of Study:

You may stay on study for as long as you are benefitting. You will be taken off study early
if the disease gets worse or you experience intolerable side effects.

End-of-Study Visit:

After you go off study, you will have an end-of-study visit. At this visit, the following
tests and procedures will be performed:

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

- You will have a performance status evaluation.

- Blood (about 2-3 teaspoons) will be drawn for routine tests and possibly blood
clotting tests.

- You will have a CT or MRI of the abdomen and pelvis to check the status of the disease.

- You will be asked if you have experienced any side effects.

This is an investigational study. Paclitaxel is FDA approved and commercially available for
the treatment of breast cancer, nonsmall cell lung cancer, ovarian cancers, and treatment of
AIDS-related Kaposi's sarcoma (KS). Bevacizumab is FDA approved and commercially available
for use in combination with chemotherapy in patients with colon cancer, but its use in this
combination for this type of cancer is considered experimental.

Up to 20 participants will take part in this study. All will be enrolled at M. D. Anderson.


Inclusion Criteria:



1. Patients with histologically confirmed, advanced stage (stage IVB), recurrent, or
persistent small cell, large cell, or neuroendocrine tumor of the uterine corpus and
cervix

2. All patients must have measurable disease. Measurable disease is defined as at least
one lesion that can be accurately measured in at least one dimension (longest
dimension to be recorded). Each lesion must be > / = 20 mm when measured by
conventional techniques, including palpation, plain x-ray, CT, and MRI, or > / = 10
mm when measured by spiral CT. Biopsy confirmation is required if the lesion measures
< 30 mm or if the treating physician determines it is clinically indicated.

3. Patients must have at least one "target lesion" to be used to assess response on this
protocol as defined by RECIST. Tumors within a previously irradiated field will be
designated as "non-target" lesions unless progression is documented or a biopsy is
obtained to confirm persistence at least 90 days following completion of radiation
therapy.

4. Patients must have adequate: BONE MARROW FUNCTION: Absolute neutrophil count (ANC)
greater than or equal to 1,500/mcl and platelets greater than or equal to
100,000/mcl. RENAL FUNCTION: Creatinine less than or equal to 1.5 x institutional
upper limit normal (ULN), and measured or estimated creatinine clearance greater than
or equal to 50 ml/min. For the purpose of estimating the creatinine clearance, the
formula of Jelliffe should be utilized. HEPATIC FUNCTION: Bilirubin less than or
equal to 1.5 x ULN. SGOT and alkaline phosphatase less than or equal to 2.5 x ULN

5. Patients must have adequate: BLOOD COAGULATION PARAMETERS: PT such that international
normalized ratio (INR) is < / = 1.5 (or an in-range INR, usually between 2 and 3, if
a patient is on a stable dose of therapeutic warfarin) and a PTT < 1.2 times the
upper limit of normal. NEUROLOGIC FUNCTION: Neuropathy (sensory and motor) less than
or equal to CTCAE grade 1.

6. Patients must have signed an approved informed consent and authorization permitting
release of personal health information.

7. Patients with ECOG Performance Grade of 0 or 1

8. Patients must be free of clinically significant infection.

Exclusion Criteria:

1. Patients who have progressed through or recurred within 3 months of treatment with a
taxane agent administered on a weekly basis.

2. Patients who have previously been treated with bevacizumab or other anti-angiogenic
agents

3. Patients who are less than 4 weeks from prior chemotherapy and/or radiation therapy

4. Patients with ECOG Performance Grade of 2, 3 or 4

5. Patients with a history of other invasive malignancies, with the exception of
non-melanoma skin cancer, are excluded if there is any evidence of other malignancy
being present within the last 5 years. Patients are also excluded if their previous
cancer treatment contraindicates this protocol therapy

6. Subjects meeting any of the following criteria are ineligible for study entry: (a)
Inability to comply with study and/or follow-up procedures (b) Current, recent
(within 4 weeks of the first infusion of this study), or planned participation in an
experimental drug study other than a Genentech-sponsored bevacizumab cancer study

7. Inadequately controlled hypertension (defined as systolic blood pressure >140 or
diastolic blood pressure > 90 mmHg on antihypertensive medications)

8. Any prior history of hypertensive crisis or hypertensive encephalopathy

9. New York Heart Association (NYHA) Grade II or greater congestive heart failure

10. History of myocardial infarction or unstable angina within 6 months prior to study
enrollment

11. History of stroke or transient ischemic attack within 6 months prior to study
enrollment

12. Known metastatic cervical cancer to the central nervous system

13. Significant vascular disease (e.g., aortic aneurysm, aortic dissection)

14. Symptomatic peripheral vascular disease

15. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to study enrollment or anticipation of need for major surgical procedure during
the course of the study

16. Core biopsy or other minor surgical procedure, excluding placement of a vascular
access device, within 7 days prior to study enrollment

17. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months prior to study enrollment

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

19. Proteinuria at screening as demonstrated by urine dipstick for proteinuria > / = 2+
(patients discovered to have > / = 2+ proteinuria on dipstick urinalysis at baseline
should undergo a 24 hour urine collection and must demonstrate < / = 1g of protein in
24 hours to be eligible)

20. Known hypersensitivity to any component of bevacizumab

21. Pregnant (positive pregnancy test) or lactating

22. Patients receiving black cohosh, dong quai, valerian, St. John's wort, kava kava,
gotu kola. Patient cannot have received these medications within 14 days of therapy
start.

23. Patients with a known hypersensitivity to taxanes, Cremophor EL (polyoxyethylated
castor oil), or any component of the formulation.

24. History of hemoptysis (>/= ½ teaspoon of bright red blood per episode) within 1 month
prior to Day 1

25. Evidence of bleeding diathesis or significant coagulopathy (in the absence of
therapeutic anticoagulation)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression-free survival (PFS)

Outcome Description:

Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.

Outcome Time Frame:

Baseline to 6 Months, or disease progression.

Safety Issue:

No

Principal Investigator

Michael M. Frumovitz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2007-0324

NCT ID:

NCT00626561

Start Date:

February 2008

Completion Date:

July 2011

Related Keywords:

  • Cervical Cancer
  • Uterine Cancer
  • Cervical Cancer
  • Uterine Cancer
  • Bevacizumab
  • Avastin
  • Anti-VEGF monoclonal antibody
  • rhuMAb-VEGF
  • Paclitaxel
  • Taxol
  • Uterine Cervical Neoplasms
  • Uterine Neoplasms
  • Neuroendocrine Tumors

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030