NCT00635245撤回1 期
A Phase 1 Pharmacodynamic Study Of CP-751,871 As Neoadjuvant Treatment For Early Breast Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- Pfizer
- 主要终点
- Tumor total choline (tCho) changes determined by magnetic resonance spectroscopy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Tumor total choline (tCho) changes determined by magnetic resonance spectroscopy
次要结局
- Safety, tolerability and human anti-human antibodies (HAHA) response
- Tissue markers
- Measure of tumor glucose levels
- Pathological response
- Tumor size by MRI
研究者
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