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Study of Dose-Dense Adriamycin Plus Cytoxan (AC) Followed by Either Abraxane or Taxol With Bevacizumab as Adjuvant Therapy for Patients With Breast Cancer

Information source: Abraxis BioScience Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer

Intervention: Cytoxan (Drug); Neulasta (Drug); Bevacizumab (Drug); ABI-007 (Drug); Taxol (Drug); Adriamycin (Drug); ABI-007 plus Bevacizumab (Drug); ABI-007 plus Bevacizuman (Drug); ABI-007 plus Bevacizumag (Drug); ABI-007 plus Bevacizumab (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Abraxis BioScience Inc.

Summary

The primary objective of this study is to compare the safety of dose-dense Abraxane 260 mg/m^2 or Taxol 175 mg/m^2 given every 2 weeks following dose-dense AC chemotherapy. Bevacizumab will be administered at 10 mg/kg every 2 weeks throughout chemotherapy, and then at 15 mg/kg every 3 weeks following chemotherapy.

Clinical Details

Official title: An Open-Label, Randomized, Comparative Pilot Study of Dose-Dense Adriamycin Plus Cytoxan (AC) Followed by Either Abraxane or Taxol With Bevacizumab as Adjuvant Therapy for Patients With Breast Cancer

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

Primary outcome:

The primary safety endpoint is the incidence of treatment-emergent toxicities as 3 and 6 months following the completions of chemotherapy.

The secondary safety endpoints are

Chemotherapy delivered in terms of : cumulative dose of chemotherapy delivered (mg/m^2), average dose intensity (mg/m^2/week), and the incidence of patients experiencing dose modifications, dose interruptions, and premature discontinuation of study drug.

Change in percent left ventricular fraction (% LVEF).

Laboratory abnormalities and myelosuppression.

Pegfilgrastim use

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

A patient will be eligible for inclusion in this study only if all of the following criteria are met:

- Females, age greater than or equal to 18 to less than or equal to 70 years old.

- ER and PR status have been determined.

- Operable, histologically confirmed adenocarcinoma of the breast

- Must meet 1 of the following criteria:

- T1-3, N1-3, M0, regardless of ER or PR status.

- T > 2 cm, N0, M0 (T2-3N0M0), regardless of ER or PR status.

- T > 1 cm, N0, M0, ER or PR positive and grade 3

- Patients with one sentinel lymph node metastasis 0. 2-2 mm in size are not required

to undergo completion axillary dissection unless only 1 sentinel lymph node was examined. This completion axillary dissection is optional if 1 out of 2 or more sentinel lymph nodes is positive for a micrometastasis. Therefore if 1 of 1 sentinel lymph node is positive for micrometastasis(0. 2-2 mm), then a completion axillary dissection is required.

- Patients with more than one sentinel node micrometastasis or 1 node with a

micrometastasis > 2 mm and/or T3 disease must undergo completion, standard axillary dissection.

- Note: the following are not eligible-

T1b,c,N0M0 and ER or PR positive and grade 1 or 2 Tx tumors (regardless of nodal status) T4 disease [i. e., patients with fixed tumor, peau d'orange skin changes, skin ulcerations, or inflammatory changes

- Note: Sentinel lymph node micrometastasis < 0. 2 mm in considered N0 disease

- Negative surgical margins on lumpectomy or mastectomy specimen (no ink on invasive

cancer and no ink on DCIS).

- ECOG performance status 0-1

- Normal ECG (as assessed by the investigator).

- No pre-existing peripheral neuropathy.

- It has not been longer than 84 days since the date of definitive surgery (eg,

mastectomy or in the case of a breast-sparing procedure, axillary dissection).

- Laboratory values must be as follows:

- White blood cell count: > or equal to 3,000/mm^3

- Absolute neutrophil count:> or equal to 1,500/mm^3

- Platelets:> or equal to 100,000/mm^3

- Hemoglobin: > or equal to 8g/dL

- Bilirubin:< or equal to the institution's ULN

- Cretinine: < or equal to 1. 7 mg/dL

- AST and ALT and alkaline phosphatase may be up to 2. 5 x institutional.

- All staging studies including physical exam, chest x-ray, and bone scan must show no

evidence of metastatic disease, including suspicious lymphadenopathy or skin nodules on physical exam. A chest x-ray and bone scan are mandatory; however, all other staging studies are at the treating physician's discretion. Any other staging test (eg, CT scans, MRI studies, ultrasound of abdomen, PET scans) must be negative for metastatic disease. An abdominal CT scan or PET scan is mandatory for patients with liver function tests elevated above the ULN to rule out metastic disease. If the patient has a stafing PET scan then a bone scan is not necessary, but a chest x-ray is required.

- Patient has a negative serum pregnancy test < or equal to 14 days of the first dose of

study drug (patients of childbearding potential).

- If fertile, patient has agreed to us an acceptable method of birth control to avoid

pregnancy [Note: oral contraceptives are not allowed] for the chemotherapy and hormonal therapy and for 6 months thereafter.

- If obese, a patient must be treated with doses calculated using his/her actual BSA

(the physician must be comfortable treating at the full BSA dose regardless of BSA).

- Patient has signed a Patient Informed Consent Form.

Exclusion Criteria:

A patient will not be eligible for inclusion in this study if any of the following criteria apply:

- Patinets with HER-2 positive breast cancer (IHC 3+ or FISH +) who are eligible for

adjuvant Herceptin therapy.

- Stage IV breast cancer (M1 disease on TNM staging system).

- Prior anthracycline, anthracenedione (mitoxantrone), or taxane therapy

- Neoadjuvant therapy for this breast cancer.

- Previous invasive cancers if treated < 5 years prior to entering this study, except

basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix; the latter are not required to have occurred more than 5 years prior to study entry.

- Prior invasive breast cancer if diagnosed < 5 years prior to entering study. Patients

must have finished adjuvant hormonal therapy prior registration. Patients with prior DCIS are eligible. Patients with DCIS who were treated with tamoxifen must have finished tamoxifen prior to registration.

- Serious medical illness, other than that treated by this study, which would limit

survival to < 4 years, or psychiatric condition that would prevent informed consent and compliance with study treatment.

- Uncontrolled or severe cardiovascular disease including recent (< or equal to 12

months)

- Active uncontrolled bacterial, viral (including clinically defined AIDS), or fungal

infection

- Patients with active or chronice hepatitis with abnormal LFTs or patients who are

known to be HIV positive.

- Uncontrolled disease such as uncontrolled diabetes.

- Any Prior history of hypertensive crisis or hypertensive encephalopathy.

- Any known CNS disease.

- Known hypersensitivity to any component of bevacizumab.

- No history of cerebrovascular accident or transient ishemic attack at any time

- Active symptomatic vascular disease, e. g.aortic aneurysm or aortic dissection, an no

peripheral vascular disease, e. g. claudication, within six months of study entry.

- No major surgical procedure, open biopsy, or significant traumatic injury within 28

days and no core biopsy or minnor surgical procedure (excluding placement of a vascular access device) within seven days of study entry. No anticipated need for

major surgical procedure during the course of study - No history of abdominal fistula,

gastronial perforation, or intra- abdominal process within six months of study entry.

- No serious non-healing wound, ulcer, or bone fracture

- No proteinuria at screening as demonstrated by urine protein: urine creatinine (UPS)

ratio of > or equal to 1. 0 or urine dipstick for proteinuria > or equal to 2+ (patients discovered to have > or equal to 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urnie collection and must demonstrate < or equal to 1g or protein in 24 hours to be eligible).

- Inadequately controlled hypertension (definded as systolic blood pressure > 150 mmHg

and /or diastolic blood pressure> 100 mmHg on antihypertensive medications) or NYHA Grade 2 or greater congestive heart failure.

- History or coagulopathy, bleeding diathesis, therapeutic anti coagulation other than

low dose or chronic ASA > or equal to 325 mg per day. Low dode coumadin for anticoagulation of venous access device or low dose molecular weight heparin (LMWH) for deep vein thrombosis prophylaxis or low dose (325 mg or less) ASA prophylaxis are allowed, but are best avoided if the treating physician feels it is safe to do so.

- LVEF on cardiac ECHO < 50% (or institutional LLN)and > or equal to 70%

- Patients receiving concurrent immunotherapy.

- A history of other malignancy within the last 5 years, which could affect the

diagnosis or assessment of breast cancer recurrence or which could shorten a patient's survival

- Patient has had an organ allograft

- Patient is pregnant or breastfeeding

- Patient is unable to comply with requirments of study

- Patient is recieving any other investigational drugs

Locations and Contacts

Birmingham, Alabama 35205, United States

Sedona, Arizona 86336, United States

Denver, Colorado 80220, United States

Torrington, Connecticut 06790, United States

Indianapolis, Indiana 46227, United States

Minneapolis, Minnesota 55404, United States

Columbia, Missouri 65201, United States

St. Louis, Missouri 63136, United States

Henderson, Nevada 89052, United States

Raleigh, North Carolina 27607, United States

Eugene, Oregon 97401, United States

Greenville, South Carolina 29615, United States

Fort Worth, Texas 76104, United States

Fredericksburg, Texas 78624, United States

Dallas, Texas 75231, United States

Tyler, Texas 75702, United States

Houston, Texas 77024, United States

McAllen, Texas 78503, United States

Bedford, Texas 76022, United States

Longview, Texas 75601, United States

El Paso, Texas 79915, United States

Austin, Texas 78731, United States

Dallas, Texas 75246, United States

Waco, Texas 76712, United States

Norfolk, Virginia 23502, United States

Fairfax, Virginia 22031, United States

Vancouver, Washington 98684, United States

Additional Information

Starting date: August 2006
Ending date: December 2008
Last updated: June 6, 2008

Page last updated: June 20, 2008

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