CP-751871 In Treating Women With Early-Stage Breast Cancer That Can Be Removed By Surgery

NCT ID: NCT00635245

Last Updated: 2015-03-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL

Brief Summary

RATIONALE: Monoclonal antibodies, such as CP-751871, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.

PURPOSE: This phase I trial is studying the side effects and best way to give CP-751871 in treating patients with early-stage breast cancer that can be removed by surgery.

Detailed Description

Primary

• To evaluate the change in total tumor choline levels in women with operable early breast cancer in response to neoadjuvant CP-751871 treatment.

Secondary

• To assess changes in tumor glucose levels after CP-751871 treatment using magnetic resonance spectroscopy in these patients.
• To assess the safety, tolerability, and immunogenicity of CP-751871 in these patients.
• To assess the effect of CP-751871 on Insulin-like Growth Factor 1 receptor (IGF-1R) signaling markers in tumor tissues in these patients.
• To assess the clinical efficacy of CP-751871 in these patients (MRI and pathological responses).

OUTLINE: Patients receive CP-751871 IV over 5 hours on days 1 and 22 and undergo magnetic resonance spectroscopy on days 8 and 29. Patients may also undergo surgery between days 29-43 to obtain a tumor sample for analysis of markers related to the IGR-1R pathway.

After completion of study treatment, patients will be followed for 5 months.

Conditions

Breast Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

figitumumab

Intervention Type: BIOLOGICAL

imaging biomarker analysis

Intervention Type: OTHER

laboratory biomarker analysis

Intervention Type: OTHER

pharmacological study

Intervention Type: OTHER

conventional surgery

Intervention Type: PROCEDURE

magnetic resonance spectroscopic imaging

Intervention Type: PROCEDURE

neoadjuvant therapy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed early operable adenocarcinoma of the breast
• No evidence of invasive lobular breast disease
• Measurable disease, defined as at least 1 lesion ≥ 2 cm by MRI
• Measurable levels of total choline according to institutional criteria by magnetic resonance spectroscopy
• Must have available or scheduled core breast biopsy procedure
• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Menopausal status not specified
• ECOG performance status 0-1
• Platelet count ≥ 100,000/mm^³
• Neutrophil count ≥ 1,500/mm³
• Creatinine < 1.5 times upper limit of normal (ULN)
• Bilirubin < 1.5 times ULN
• ALT and AST < 2.5 times ULN
• Fertile patients must use adequate barrier method contraception during and for at least 150 days after completion of study treatment
• Ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures
• No known hypersensitivity to monoclonal antibodies
• No prior or active malignancies other than curatively treated in situ carcinoma of the cervix, uterus, or basal cell or squamous cell carcinoma of the skin
• No serious uncontrolled medical disorder or active infection that would impair the ability to receive study treatment
• No significant active cardiac disease including any of the following:

• Uncontrolled high blood pressure (i.e., systolic blood pressure [BP] > 160 mm Hg and diastolic BP > 95 mm Hg)
• Unstable angina
• Deep venous thrombosis
• Pulmonary embolism
• Cerebrovascular attack
• Valvular disease
• Congestive heart failure
• Myocardial infarction with the past 6 months
• Serious cardiac arrhythmias
• No dementia or significantly altered mental status that would limit the understanding or rendering of informed consent and compliance with study requirements

PRIOR CONCURRENT THERAPY:

• More than 4 weeks since prior surgery and recovered
• More than 2 weeks since high-dose corticosteroid therapy (i.e., ≥ 100 mg prednisone per day or > 40 mg dexamethasone per day)
• No prior anti-IGF-1R based investigational therapy
• No prior systemic therapy for primary disease
• No concurrent chronic systemic high-dose immunosuppressive steroid therapy

• Low-dose steroids for nausea and vomiting control allowed
• Topical corticosteroid applications, inhaled sprays, eye drops or local injections (e.g., intraocular) allowed
• No concurrent other anticancer drugs or therapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Pfizer, Inc.

Principal Investigators

Douglas Yee, MD

Role: PRINCIPAL_INVESTIGATOR

Masonic Cancer Center, University of Minnesota

Other Identifiers

P30CA077598

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-CDR0000589252

Identifier Type: -

Identifier Source: secondary_id

A4021012

Identifier Type: -

Identifier Source: org_study_id