A Phase II Study of AZD2171 in Breast Cancer Stage IV (10006202)

NCT00244881 | Completed Phase 2 Results

• 4 other identifiers: NCI-2012-0293705-160U01CA062490CDR0000445438
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

AZD2171 (cediranib maleate) 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. This phase II trial is studying how well AZD2171 works in treating patients with refractory stage IV breast cancer

Conditions

Male Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Fraction of Patients With Increased Levels of Circulating Endothelial Cells

  An exact 95% confidence interval (CI) will be calculated for the CEC response rate. With 26 patients, this CI will be no wider than 40% (e.g., if 13 of 26 patients respond, the CI is 30% to 70%).

  After 3 weeks of treatment

• Objective Response Rate (ORR = CR + PR) Classified According to RECIST Criteria

  RECIST 1.0 Criteria

  Up to 7 years

Secondary Outcomes (1)

• Response/Stable Disease Rate Defined as the Percentage of Patients Demonstrating CR + PR + SD

  12 weeks

Study Arms (1)

Treatment (cediranib maleate)

EXPERIMENTAL

Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.

Drug: cediranib maleate; Other: laboratory biomarker analysis

Interventions

cediranib maleate DRUG

Given orally

Also known as: AZD2171, Recentin

Treatment (cediranib maleate)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (cediranib maleate)

Eligibility Criteria

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

You may qualify if:

• Patients must have histologically or cytologically confirmed Breast Cancer, stage IV, including:
• "Breast neoplasms malignant and unspecified (incl nipple)","Breast and nipple neoplasms malignant","Breast cancer stage IV","10006202"
• Breast neoplasms malignant and unspecified (incl nipple)","Breast and nipple neoplasms malignant","Breast cancer recurrent","10006198"
• "Breast neoplasms malignant and unspecified (incl nipple)","Breast and nipple neoplasms malignant","Inflammatory carcinoma of breast stage IV","10021979"
• Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral CT scan
• Patients must have refractory breast cancer, defined as overt clinical tumor progression on most recent treatment with either hormonal therapy, chemotherapy, and/or trastuzumab therapy; patients with up to 3 prior chemotherapy regimens and with any number of biological (hormonal, trastuzumab) regimens for metastatic breast cancer will be eligible
• Life expectancy of greater than 3 months as assessed by the patient's primary oncologist
• Absolute neutrophil count \> 1,500/mcL
• Platelets \> 100,000/mcL
• Hemoglobin \>= 8 g/dL
• Prothrombin time \< institutional upper limit of normal (ULN)
• Total bilirubin =\< 1.5 x ULN
• AST(SGOT)/ALT(SGPT) =\< 2.5 × ULN
• Creatinine within normal institutional limits
• Urinalysis with \< 1+ proteinuria

You may not qualify if:

• Patients who have had chemotherapy, radiotherapy, or major surgery within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
• Patients may not be receiving any other investigational agents nor have participated in an investigational trial within the past 30 days
• Patients may not have been previously treated with an anti-angiogenesis agent
• \\Patients may not be receiving any medication that may markedly affect renal function (e.g., vancomycin, amphotericin, pentamidine); these medications will also not be permitted after the start of the study
• Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events; a head CT or MRI must be performed at baseline
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD2171
• Any contraindications/barrier to oral medication
• EKG abnormalities of known clinical significance, such as prolonged QT (mean QTc \> 470 msec, with Bazett's correction, in screening electrocardiogram or history of familial long QT syndrome); an EKG is required for study entry
• Uncontrolled intercurrent illness including, but not limited to hypertension, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant women are excluded from this study because AZD2171 is a VEGF inhibitor with known abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with AZD2171, breastfeeding should be discontinued if the mother is treated with AZD2171
• HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with AZD2171; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
• Patients at increased risk for compromised LVEF requiring concurrent use of drugs or biologics with proarrythmic potential; these drugs are prohibited during studies with AZD2171 (refer to Appendix J for a listing of these agents)
• Patients with a New York Heart Association classification of III or IV are excluded (NOTE: patients classified as class II are eligible if controlled on medication and stable with increased monitoring)

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Breast Neoplasms, Male; Breast Neoplasms

Interventions

cediranib

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr Harold Burstein
• Organization: Dana-Farber Cancer Institute

hburstein@partners.org

617-632-3800

Study Officials

• Harold Burstein

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2005
• First Posted: October 27, 2005
• Study Start: September 1, 2005
• Primary Completion: August 1, 2007
• Study Completion: December 1, 2007
• Last Updated: December 7, 2015
• Results First Posted: December 23, 2013

Record last verified: 2013-11

Locations

US (1)