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A Phase II Trial of a Vascular Endothelial Growth Factor (VEGF) Monoclonal Antibody, AVASTIN, in Combination With Cytotoxic Chemotherapy CARBOPLATIN and PACLITAXEL for Recurrent/Advanced Endometrial Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Endometrial Carcinoma

Thank you

Trial Information

A Phase II Trial of a Vascular Endothelial Growth Factor (VEGF) Monoclonal Antibody, AVASTIN, in Combination With Cytotoxic Chemotherapy CARBOPLATIN and PACLITAXEL for Recurrent/Advanced Endometrial Cancer


Exclusion Criteria

Disease-Specific Exclusions

- Patients with a concomitant malignancy other than non-melanoma skin cancer. Patients
with a prior malignancy who have been disease-free for greater than 5 years or who
received prior chemotherapy for that malignancy.

- Patients in whom pathological confirmation of the tumor is not obtainable. General
Medical Exclusions

- Patients with concomitant medical illness such as serious uncontrolled infection,
uncontrolled angina, or serious peripheral neuropathy, which, in the opinion of the
treating physician, make the treatments prescribed on this study unreasonably hazardous
for the patient.

- Patients with third degree or complete heart block are not eligible unless a pacemaker
is in place. Patients on medications which alter cardiac conduction, such as digitalis,
beta-blockers, or calcium channel blockers, or who have other conduction abnormalities
or cardiac dysfunction may be placed on study at the discretion of the investigator.

- Patients whose circumstances will not permit study completion or adequate follow-up.

- Patients who are sensitive to E. Coli-derived drug preparations.

- Life expectancy of less than 12 weeks.

- 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 avastin
cancer study.

- Inadequately controlled hypertension (defined as systolic blood pressure greater than
150 and/or diastolic blood pressure greater than 100 mmHg on antihypertensive
medications).

- Any prior history of hypertensive crisis or hypertensive encephalopathy.

- New York Heart Association (NYHA) Grade II or greater congestive heart failure (see
Appendix C).

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

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

- Known CNS disease.

- Significant vascular disease (e.g., aortic aneurysm, aortic dissection). Symptomatic
peripheral vascular disease

- Evidence of bleeding diathesis or coagulopathy. Blood coagulation parameters: PT such
that international normalized ratio (INR) is less than 1.5 (or an in range INR, between
2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a PTT less than
1.5 times the institutional upper limit of normal.

- 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.

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

-History of abdominal fistula, gastrointestinal perforation, or intra- abdominal abscess
within 6 months prior to study enrollment. Patients with clinical symptoms or signs of
gastrointestinal obstruction and who require parenteral hydration and/or nutrition.

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

- Proteinuria at screening as demonstrated by:

- Urine protein:creatinine (UPC) ratio greater than or equal to 1.0 at screening

- Known hypersensitivity to any component of avastin.

- Pregnant (positive pregnancy test) or lactating. Refusal to use of effective means of
contraception (men and women) in subjects of child-bearing potential.


Inclusion Criteria:



- Patients must have histologically confirmed primary Stage III or Stage IV (see FIGO
staging—Appendix I) or recurrent endometrial carcinoma with MEASURABLE disease whose
potential for cure by radiation therapy or surgery alone or in combination is very
poor. Recurrent disease must be biopsy confirmed.

- Patients may have received prior cytotoxic chemotherapy

(1 therapy) excluding a platinum/taxane. Patients may have received prior hormonal
therapy or therapy with biologic agents, but such therapies must be discontinued 4
weeks prior to entry on this study.

- Patients in whom both radiation and chemotherapy is planned may receive radiation
prior to entry on this study (order not specified). At least four weeks should have
elapsed since completion of RT involving the whole pelvis or over 50% of the spine.

- Patients must be 18 years of age or older.

Exclusion Criteria:

- Patients with a concomitant malignancy other than Genentech, Inc Page 27 of 62
Bevacizumab Protocol 03-10-08 Page 27 non-melanoma skin cancer. Patients with a prior
malignancy who have been disease-free for < 5 years or who received prior
chemotherapy for that malignancy.

- Patients in whom pathological confirmation of the tumor is not obtainable.

- Patients with concomitant medical illness such as serious uncontrolled infection,
uncontrolled angina, or serious peripheral neuropathy, which, in the opinion of the
treating physician, make the treatments prescribed on this study unreasonably
hazardous for the patient.

- Patients with third degree or complete heart block are not eligible unless a
pacemaker is in place. Patients on medications which alter cardiac conduction, such
as digitalis, beta-blockers, or calcium channel blockers, or who have other
conduction abnormalities or cardiac dysfunction may be placed on study at the
discretion of the investigator.

- Life expectancy of less than 12 weeks.

- Patients who are sensitive to E. Coli-derived drug preparations.

- 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To estimate the progression free survival (PFS=date of progression of disease or death) at 6 months using bevacizumab, carboplatin, and paclitaxel in patients with measurable disease for advanced/recurrent endometrial cancer

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Peter Rose, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Food and Drug Administration

Study ID:

20806

NCT ID:

NCT00879359

Start Date:

December 2007

Completion Date:

February 2012

Related Keywords:

  • Endometrial Carcinoma
  • Carcinoma
  • Endometrial Neoplasms
  • Adenoma

Name

Location

Cleveland ClinicCleveland, Ohio  44195