AZD2171 and Combination Chemotherapy in Treating Women With Locally Advanced Breast Cancer

NCT00310089 | Completed

• 3 other identifiers: CDR0000466185NCI-06-C-0057NCI-7088
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving AZD2171 together with combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed and may kill more tumor cells. PURPOSE: This randomized clinical trial is studying how well giving AZD2171 together with combination chemotherapy works in treating women with locally advanced breast cancer.

Conditions

Breast Cancer

Keywords

stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; inflammatory breast cancer

Interventions

filgrastim BIOLOGICAL

pegfilgrastim BIOLOGICAL

cediranib maleate DRUG

cyclophosphamide DRUG

docetaxel DRUG

doxorubicin hydrochloride DRUG

laboratory biomarker analysis OTHER

conventional surgery PROCEDURE

neoadjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed breast cancer, meeting 1 of the following criteria: * Previously untreated disease * Inflammatory disease * Locally advanced breast cancer (stage IIIA, IIIB, or IIIC disease) * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion (longest diameter) ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan or breast MRI * Accessible tumor tissue for serial biopsy * No overexpression of HER2 * No known brain metastases secondary to breast cancer * Hormone receptor status not specified PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Karnofsky performance status 60-100% * Life expectancy \> 3 months * Female only * Menopausal status not specified * Absolute neutrophil count ≥ 1,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 8 g/dL * Bilirubin normal (≤ 2 times upper limit of normal \[ULN\] if evidence of Gilbert's disease and elevated bilirubin not related to tumor or other liver disease) * AST and ALT ≤ 2.5 ULN * Creatinine normal OR creatinine clearance ≥ 60 mL/min * Proteinurea ≤ +1 on 2 consecutive dipsticks at least 1 week apart * INR ≤ 1.5 * LVEF ≥ 50% by MUGA or echocardiogram without clinical symptoms or signs of heart failure * Fertile patients must use effective contraception * Not pregnant or nursing * Negative pregnancy test * No peripheral neuropathy ≥ grade 2 * No known CNS disease, including history of stroke or seizures not controlled by standard medical therapy * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxel, doxorubicin hydrochloride, or cyclophosphamide * No uncontrolled intercurrent illness including, but not limited to, any of the following: * Hypertension * Ongoing or active infection requiring IV antibiotics * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Peripheral vascular disease ≥ grade II * Psychiatric illness/social situation that would preclude study treatment * No nonhealing wounds or bone fractures within the past 28 days * No history of an active malignancy except carcinoma in situ of the cervix or nonmelanomatous skin cancer in the past 5 years PRIOR CONCURRENT THERAPY: * No prior surgery, chemotherapy, or hormonal therapy for breast cancer * No concurrent medication that may affect renal function (e.g., amphotericin B or pentamidine) * No full-dose oral or parenteral anticoagulants or chronic daily treatment with aspirin (dose \> 325 mg/day) within the past 10 days * No other concurrent investigational agents * No other concurrent commercially available drugs for this cancer * No concurrent antiretroviral therapy for known HIV infection * No major surgery within the past 28 days

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Inflammatory Breast Neoplasms

Interventions

Filgrastim; pegfilgrastim; cediranib; Cyclophosphamide; Docetaxel; Doxorubicin; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Diterpenes; Terpenes; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Combined Modality Therapy; Therapeutics

Study Officials

• Neelima Denduluri, MD

  National Cancer Institute (NCI)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: March 29, 2006
• First Posted: April 3, 2006
• Study Start: January 1, 2006
• Study Completion: July 1, 2007
• Last Updated: June 20, 2013

Record last verified: 2007-01

Locations

US (2)