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

NCT00635245 | Withdrawn Phase 1

• 3 other identifiers: A4021012P30CA077598NCI-CDR0000589252
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Keywords

stage IA breast cancer; stage IB breast cancer; stage II breast cancer

Outcome Measures

Primary Outcomes (1)

• Tumor total choline (tCho) changes determined by magnetic resonance spectroscopy

Secondary Outcomes (5)

• Safety, tolerability and human anti-human antibodies (HAHA) response

• Tissue markers

• Measure of tumor glucose levels

• Pathological response

• Tumor size by MRI

Interventions

figitumumab BIOLOGICAL

imaging biomarker analysis OTHER

laboratory biomarker analysis OTHER

pharmacological study OTHER

conventional surgery PROCEDURE

magnetic resonance spectroscopic imaging 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 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

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

Sponsors & Collaborators

• Pfizer: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Breast Neoplasms

Interventions

figitumumab; Magnetic Resonance Spectroscopy; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Combined Modality Therapy; Therapeutics

Study Officials

• Douglas Yee, MD

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 12, 2008
• First Posted: March 13, 2008
• Last Updated: March 11, 2015

Record last verified: 2015-03