NCT00933309已完成1 期
The Impact of Obesity and Obesity Treatments on Breast Cancer: A Phase I Trial of Exemestane With Metformin and Rosiglitazone for Postmenopausal Obese Women With ER+ Metastatic Breast Cancer
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity (DLT)
研究概览
简要总结
The goal of this clinical research study is to find the highest tolerable dose of Avandamet that can be given in combination with exemestane to patients who are obese and postmenopausal with hormone-receptive-positive breast cancer that has spread to other parts of the body.
详细描述
The Study Drugs:
Exemestane decreases the ability of estrogen to help cancer cells grow. This could cause the cancer cells to die.
Avandamet contains two drugs commonly used to control blood sugar levels in patients with diabetes (metformin and rosiglitazone).
If you are found to be eligible to take part in this study, the dose of Avandamet you receive will depend on when you joined this study. The first group of participants will receive the lowest dose level of Avandamet. Each new group will receive a higher dose of Avandamet than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of Avandamet is found.
All participants will receive the same dose level of exemestane.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Overweight or obese postmenopausal women with a history of biopsy-proven estrogen receptor positive and/or progesterone receptor positive breast cancer and clinical evidence of metastatic disease. Overweight and obesity are defined by the WHO as a BMI of 25 - 29.9 and >/= 30 kg/m^2 respectively. Postmenopausal status is defined by one of the following: a) no spontaneous menses for over 1 year, in women >55 years; Continued in inclusion criterion #
- •Continuation from inclusion #1: b) no spontaneous menses within the past 1 year in women </= 55 years with postmenopausal gonadotrophin levels (LH and FSH levels > 40 IU/L) or postmenopausal estradiol levels (<10 pg/mL); or c) bilateral oophorectomy.
- •Prior endocrine therapy, biologic therapy and chemotherapy are allowed, either in the adjuvant setting or for metastatic breast cancer.
- •Prior exemestane, metformin, or rosiglitazone is allowed if taken longer than 7 days prior to enrollment.
- •Localized radiotherapy, which does not influence the signal of evaluable lesion, is allowed prior to the initiation of study medications.
- •Performance status </= 2 ECOG.
- •Absolute neutrophil count (ANC) >/= 1000/µl, platelets >/= 75,000/µl, hemoglobin >/= 8.5 gm/dL; serum creatinine < 1.4 mg/dL; bilirubin < 1.8 mg/dL; ALT or AST </= 2.5 x ULN if no demonstrable liver metastases or </= 5 x ULN in presence of liver metastases; alkaline phosphatase < 3 x upper limit of normal; calcium </= 11.0 mg/dL.
- •Patients must be competent to give informed consent and to state that they understand the investigational nature of the proposed treatment.
排除标准
- •Extensive radiotherapy within previous 4 weeks (greater than or equal to 30% of marrow-bearing bone, e.g., whole pelvis or half spine).
- •Uncontrolled diabetes mellitus (hemoglobin A1C > 9 or random plasma glucose > 400 mg/dL).
- •History of acromegaly, Cushing's syndrome, Cushing's disease, Addison's disease (treated or untreated).
- •Patients with unstable angina, uncontrolled ischemic cardiac disease or symptomatic congestive heart failure (e.g. Class III or IV New York Heart Association's Functional Classification).
- •Concurrently receiving and are unwilling to discontinue hormonal (estrogen with or without progesterone) replacement therapy.
- •Other investigational drugs within the past 3 weeks or concurrently.
- •Patients with known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).
- •Laboratory results sustained at: International normalized ratio (INR) > 1.6; ALT or AST > 2.5 x ULN if no demonstrable liver metastases or > 5 x ULN in presence of liver metastasis; No more than 3 retests within screening period
- •Patients with known diagnosis of human immunodeficiency virus (HIV) infection.
- •Patients who received chemotherapy within 3 weeks (6 weeks for nitrosourea or mitomycin-C). Acute toxicities from prior therapy must have resolved to Grade </= 1 with the exception of fatigue, alopecia, or anemia.
- •Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol e.g., severe renal or hepatic impairment or currently unstable or uncompensated respiratory or cardiac conditions.
- •History of hypersensitivity to active or inactive excipients of the study medications - exemestane or metformin.
- •Untreated or clinically unstable central nervous system involvement. A patient with adequately treated brain metastases would be eligible one month after completion of surgery and/or radiation therapy if she is clinically stable.
研究组 & 干预措施
Group 1
Experimental
Exemestane alone
干预措施: Exemestane (Drug)
Group 2
Experimental
Exemestane plus Avandamet
干预措施: Exemestane (Drug)
Group 2
Experimental
Exemestane plus Avandamet
干预措施: Avandamet (Drug)
结局指标
主要结局
Dose-limiting toxicity (DLT)
时间窗: Day 1 of each cycle
次要结局
未报告次要终点
研究者
研究点 (1)
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