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Study Summary
No. 2007-0324:.......Cervix; Uterus......Michael M. Frumovitz......Gynecologic Oncology
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Study Summary Title
Study Summary
Number:
2007-0324
Study Title:A phase II evaluation of bevacizumab and paclitaxel in patients with recurrent small cell, large cell, and neuroendocrine tumors of the cervix and uterus
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Physician New Patient Referral
Name:Michael M. FrumovitzPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Gynecologic OncologyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-9599
Contact us about clinical trials
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General Information
Disease Group:Cervix
Uterus
Supported By:Genentech, Inc
Phase of Study:Phase IIReturn
Visit:
Weekly until disease progression or adverse effects prohibit further therapy
Treatment
Agents:
Bevacizumab
Paclitaxel
Home Care:none
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
n/a
Description/
Intervention:
The goal of this clinical research study is to learn if the combination of
Avastin (bevacizumab) and Taxol (paclitaxel) can help to control cancer of the
cervix or uterus. The safety of this drug combination will also be studied.
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Study Objectives / Outcomes
Primary:
To estimate the efficacy of bevacizumab and paclitaxel in patients with recurrent small cell, large cell, and neuroendocrine cervical and uterine cancers, as measured by progression-free survival.

Secondary:
1 To estimate the efficacy of bevacizumab and paclitaxel in patients with recurrent small cell, large cell, and neuroendocrine cervical and uterine cancers, as measured by overall survival.
2 To determine the response rates in patients with recurrent small cell, large cell, and neuroendocrine cervical and uterine cancers when treated with bevacizumab and paclitaxel.
3 To characterize the quality of life (QoL) in patients with recurrent small cell, large cell, and neuroendocrine cervical and uterine cancers when treated with bevacizumab and paclitaxel.
4 To determine the nature and degree of toxicity in patients with advanced or recurrent small cell, large cell, or neuroendocrine cervical and uterine cancers when treated with bevacizumab and paclitaxel.
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Study Status Information
Study Activation / Registration Date:
IRB Review and Approval Date:02/18/2008
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Terminated
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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, elcluding placement of a vacular 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 entollment

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)

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Links
Registration Number: NCT00626561
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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