Phase II Study of Cetuximab With or Without OSI-906, a Dual Insulin-like Growth Factor-1 Receptor and an Insulin Receptor Inhibitor, in Platinum-Refractory, Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
The goal of this clinical research study is to learn if the addition of OSI-906 to cetuximab can improve response. The safety of these drugs will also be studied.
Objectives:
Primary Objective(s): To assess progression-free survival (PFS) among patients with head and neck squamous cell carcinoma (HNSCC) treated with a combination of cetuximab plus OSI-906 and compare it with PFS among patients treated with cetuximab plus placebo.
Secondary Objective(s):
- To assess the safety and toxicity of these treatment regimens.
- To assess the efficacy of these two treatment regimens in terms of overall survival, response rate, and disease control rate
- To assess the efficacy of single agent OSI-906 following cetuximab treatment in terms of response rate and disease control rate in patients who cross-over from Arm B to receive single-agent OSI-906
- To explore blood-based and tissue biomarkers
详细描述
Cetuximab is designed to prevent or slow down the growth of cancer cells by blocking proteins on the cancer cell, called the epidermal growth factor receptor (EGFR).
OSI-906 is designed to prevent or slow the growth of cancer cells.
A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have histologically or cytologically confirmed recurrent or metastatic head and neck squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx.
- •Patients must be willing to have a biopsy of tumor tissue for biomarker analysis.
- •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 computed tomography (CT) scan or magnetic resonance imaging (MRI). Measurable lymph nodes are required to be >/= 15 mm in size (short axis diameter). Measurable disease in previously radiated areas is acceptable as long as there has been documented progression.
- •Patients must have disease progression: 1) After platinum-based chemotherapy for recurrent/metastatic disease OR 2) Within 6 months of receiving definitive platinum-based combined modality therapy.
- •Previous treatment with cetuximab is allowed, as long as there has been a period >/= 6 months between the last cetuximab treatment and randomization
- •All prior cytotoxic therapy must have been completed at least three weeks prior to treatment on study.
- •Age >/= 18 years
- •ECOG performance status </= 2 or Karnofsky >/= 60%
- •Patients must have normal liver function as defined below: total bilirubin </= institutional upper limit of normal and aspartate aminotransferase (AST or SGOT)/alanine aminotransferase (ALT or SGPT) </= 2.5 * institutional upper limit of normal.
- •Patients - both males and females - with reproductive potential (ie, menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures throughout the study. Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration.
- •Patients must provide verbal and written informed consent to participate in this study
- •Prior radiation treatment is acceptable as long as it has been completed one week prior to treatment on protocol.
排除标准
- •Patients may not be receiving any other investigational agents with anti-cancer activity.
- •Patients with known, untreated brain metastases. Patients with treated (irradiated or resected) brain metastases are eligible if treatment was completed >/= 28 days prior to study entry and if clinical neurologic function is stable.
- •History of severe allergic reactions attributed to compounds of similar chemical or biologic composition to OSI-906 or other agents used in the study.
- •QTc interval > 450 msec at baseline.
- •Concomitant drugs with a generally accepted risk of causing Torsades de Pointes
- •Congestive heart failure, New York Heart Association (NYHA) Class III or IV
- •History of arrhythmia which is symptomatic and requires treatment, or asymptomatic sustained ventricular tachycardia. Patients with atrial fibrillation controlled on medication are not excluded.
- •Fasting blood sugar > 150 mg/dl at baseline
- •Serious underlying medical condition which would impair the ability of the patient to receive protocol treatment, in the opinion of the treating physician.
- •Pregnant or breast-feeding females.
研究组 & 干预措施
Group A: Cetuximab + OSI-906
Cetuximab loading dose of 400 mg/m2 by vein (IV) then 250 mg/m2 weekly + OSI-906 150 mg orally twice a day. 21-Day Cycle.
干预措施: Cetuximab (Drug)
Group A: Cetuximab + OSI-906
Cetuximab loading dose of 400 mg/m2 by vein (IV) then 250 mg/m2 weekly + OSI-906 150 mg orally twice a day. 21-Day Cycle.
干预措施: OSI-906 (Drug)
Group B: Cetuximab + Placebo
Cetuximab loading dose of 400 mg/m2 by vein (IV) then 250 mg/m2 weekly + Placebo orally twice a day. 21-Day Cycle.
干预措施: Cetuximab (Drug)
Group B: Cetuximab + Placebo
Cetuximab loading dose of 400 mg/m2 by vein (IV) then 250 mg/m2 weekly + Placebo orally twice a day. 21-Day Cycle.
干预措施: Placebo (Other)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: From treatment initiation to progressive disease or death, up to 24 months for study period.
PFS is time to progressive disease or death of any cause from randomization date, assessed every 6 weeks with a total study period of approximately 24 months.
次要结局
未报告次要终点