Status:
WITHDRAWN
CP-751871 In Treating Women With Early-Stage Breast Cancer That Can Be Removed By Surgery
Lead Sponsor:
Pfizer
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
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 c...
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 gluc...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00635245
Last Update
March 11 2015
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