EUCTR2007-007027-40-FR进行中（未招募）不适用
A Multicenter open-label, phase I/II dose escalation study of oral lapatinib in combination with docetaxel in patients with HER2 positive advanced or metastatic breast cancer - LAP-DOC
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Subjects must have histological or cytological confirmed breast cancer, HER positif (IHC 3+, or IHC 2+ and FISH/CISH +, or FISH, or CISH+ only), not amenable for an alternative curative strategy in first line metastatic setting
- •Patients who receive hormonotherapy for metastastic disease or who received chemotherapy in adjuvant setting ‘if recurrence occur after 6 months are eligible
- •Patient must have not received the last injection of trastuzumanb within the six weeks
- •Subjects must have completed prior radiotherapy treatment at least 4 weeks from enrolment and recovered from all treatment-related toxicities
- •Subjects must have tissue available to prospectively determine treatment assignment and to compare tumor response with intra-tumor expression levels of relevant biomarkers
- •Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan.
- •Age ? ?18 years. Because no dosing or adverse event data are currently available on the use of lapatinib in patients <18 years of age, children are excluded from this study.
- •Life expectancy of greater than 12 weeks.
- •ECOG performance status ? 2 (Karnofsky ? ?60%)
- •Patients must have normal organ and bone marrow function as defined below:
- •Hemoglobin? 9 g/dl
- •leukocytes? 3,000/?L
- •absolute neutrophil count? 1,500/?L
- •platelets ? 100,000/?L
- •total bilirubinwithin normal institutional limits
- •AST (SGOT)/ALT(SGPT)? 2.5 X institutional upper limit of normal
- •creatinine within normal institutional limits
- •creatinine clearance ? 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- •Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram or MUGA scan. Note that baseline and on treatment scans should be performed using the same modality and preferably at the same institution.
- •The effects of lapatinib on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- •Ability to understand and the willingness to sign a written informed consent document.
- •Able to swallow and retain oral medication
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier. Patients who have had prior treatment with EGFR targeting therapies.
- •Patients may not be receiving any other investigational agents within the past 30 days or receiving concurrent anticancer therapy. In addition, all herbal (alternative) medicines are excluded
- •Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib.
- •Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, peripheral neuropathy of grade 2 or greater, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Pregnant women are excluded from this study because lapatinib is member of the 4-anilinoquinazoline class of kinase inhibitors with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with lapatinib, breastfeeding should be discontinued if the mother is treated with lapatinib
- •HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with lapatinib. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated
- •Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn’s, ulcerative colitis).
- •Previous allergic reaction to docetaxel and/or polyascorbate
- •Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors.
- •Active cardiac disease, defined as: history of uncontrolled or symptomatic angina pectoris, history of cardiac arrhythmias requiring medications, or clinically significant, with the exception of asymptomatic atrial fibrillation requiring anticoagulation, myocardial infarction < 6 months from study entry, uncontrolled or symptomatic congestive heart failure, ejection fraction below the institutional normal limit
- •Any other cardiac condition, which in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient
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