NCT00376727已完成1 期
A Phase I Study of the Safety and Tolerability of Four Doses of Cetuximab (C225) in Patients With Advanced Solid Tumors
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose of cetuximab
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as cetuximab, 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 dose of cetuximab in treating patients with advanced solid tumors.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of cetuximab in patients with advanced solid tumors.
Secondary
- Evaluate the safety and tolerability of this drug in these patients.
- Develop a detailed scale for assessment of rash in these patients.
- Investigate potential predictors of response using correlative studies on patient tissue, buccal mucosa, and blood samples.
- Obtain preliminary efficacy data and evaluate the relationship of efficacy to grade of rash.
- Correlate downstream markers (e.g., pMAPK, pAKT, and Ki-67) and the presence of epidermal growth factor receptor (EGFR) polymorphisms with clinical response and/or survival.
- Examine the levels of downstream marker proteins in buccal cells obtained pre- and post-treatment.
- Correlate basal p27 expression levels with response and/or survival.
- Determine if the presence of a K-RAS mutation influences response or survival outcome.
- Correlate the presence or absence of mutant K-RAS tumor DNA shed into patient plasma with response and/or outcome.
- Correlate levels of cytokines and chemokines with rash and clinical response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- All
- 接受健康志愿者
- 否
入选标准
- •* Signed written informed consent
- •* Histologically or cytologically proven advanced solid tumors not curable by surgery, radiation therapy or standard chemo-, immuno-, or hormonal therapy. A specific primary cancer need not have been identified (i.e., unknown primary is eligible).
- •* Patients must have received at least one prior regimen (chemotherapy and/or radiation) for metastatic disease. There is no limit to the number of prior therapies.
- •* Any prior chemotherapy must have been completed at least 4 weeks prior to start of study therapy. Previous radiation therapy must have been completed at least 2 weeks prior to start of study therapy. All side effects of prior therapy must be resolved prior to the start of study therapy.
- •* Patients with ZUBROD performance status 0-2 (see Appendix 1).
- •* Patients must have measurable disease or evaluable disease.
- •* Patients must have an estimated survival of at least 3 months.
- •* Patients with asymptomatic treated brain metastasis (surgical resection or radiotherapy) may be included if they are neurologically stable and have been off steroids for at least 4 weeks.
- •* Patients \>/= 18 years of age.
- •* Patients of reproductive potential must agree to use an effective contraceptive method while on treatment and for 3 months afterward as the effects of cetuximab on the unborn fetus are unknown.
- •* Patients must have adequate hematologic function defined as: ANC \>/= 1,500/mm3, platelets \>/= 100,000/mm3.
- •* Patients must have adequate hepatic function defined as SGOT \/= 40 ml/min.
排除标准
- •Female patients cannot be pregnant or breastfeeding as the effects of cetuximab on the unborn fetus are unknown. Documentation of a negative pregnancy test prior to treatment is required for all women of reproductive potential.
- •Uncontrolled intercurrent illness including but not limited to ongoing infection or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements.
- •Patients with symptomatic brain metastasis or still requiring steroids.
- •Patients who have received prior cetuximab therapy, prior therapy with any other drug that targets the EGF receptor (including, but not limited to, Iressa, Tarceva, Herceptin, CI1033, etc.), or prior therapy with a monoclonal antibody.
- •Patients who have received prior chemotherapy within 4 weeks or radiation therapy within 2 weeks prior to the start of study therapy.
- •Prior hypersensitivity reaction to chimerized or murine monoclonal antibody therapy.
- •Patients may not receive any other chemotherapy, radiation therapy, or biologic therapy while on study.
研究组 & 干预措施
Phase I dose escalation study
Experimental
干预措施: molecular diagnostic method (Genetic)
Phase I dose escalation study
Experimental
干预措施: immunologic technique (Other)
Phase I dose escalation study
Experimental
干预措施: laboratory biomarker analysis (Other)
Phase I dose escalation study
Experimental
干预措施: cetuximab (Biological)
结局指标
主要结局
Maximum tolerated dose of cetuximab
时间窗: December 2007
次要结局
- Safety and tolerability of cetuximab(December 2007)
- Development of a detailed scale for assessing skin rash(December 2007)
- Potential predictors of response using correlative studies(December 2007)
- Correlation of efficacy of cetuximab with grade of skin rash(December 2007)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Cetuximab and Combination Chemotherapy as First-Line Therapy in Treating Patients With Metastatic Colorectal CancerColorectal CancerNCT00556413Institut du Cancer de Montpellier - Val d'Aurelle42
终止
2 期
Cetuximab, Combination Chemotherapy, and Radiation Therapy in Treating Patients With Newly Diagnosed Stage III or Stage IV Head and Neck Cancer That Cannot Be Removed By SurgeryHead and Neck CancerNCT00646659European Organisation for Research and Treatment of Cancer - EORTC47
已完成
2 期
Phase II Randomized Trial of the Combination of Cetuximab and Sorafenib or Single Agent CetuximabRecurrent Salivary Gland CancerRecurrent Squamous Cell Carcinoma of the NasopharynxRecurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityRecurrent Squamous Cell Carcinoma of the LarynxRecurrent Verrucous Carcinoma of the LarynxSalivary Gland Squamous Cell CarcinomaStage IVB Salivary Gland CancerStage IVB Squamous Cell Carcinoma of the OropharynxRecurrent Verrucous Carcinoma of the Oral CavityStage IV Squamous Cell Carcinoma of the HypopharynxStage IVA Squamous Cell Carcinoma of the LarynxRecurrent Squamous Cell Carcinoma of the HypopharynxRecurrent Squamous Cell Carcinoma of the Lip and Oral CavityRecurrent Squamous Cell Carcinoma of the OropharynxStage IVA Squamous Cell Carcinoma of the Lip and Oral CavityStage IVA Verrucous Carcinoma of the LarynxStage IVB Squamous Cell Carcinoma of the LarynxStage IVB Squamous Cell Carcinoma of the Lip and Oral CavityStage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityMetastatic Squamous Neck Cancer With Occult Primary Squamous Cell CarcinomaRecurrent Metastatic Squamous Neck Cancer With Occult PrimaryStage IVA Salivary Gland CancerStage IVC Verrucous Carcinoma of the LarynxStage IV Squamous Cell Carcinoma of the NasopharynxStage IVA Squamous Cell Carcinoma of the OropharynxStage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage IVA Verrucous Carcinoma of the Oral CavityStage IVB Verrucous Carcinoma of the LarynxStage IVC Salivary Gland CancerStage IVC Squamous Cell Carcinoma of the Lip and Oral CavityStage IVC Verrucous Carcinoma of the Oral CavityStage IVB Verrucous Carcinoma of the Oral CavityStage IVC Squamous Cell Carcinoma of the LarynxStage IVC Squamous Cell Carcinoma of the OropharynxUntreated Metastatic Squamous Neck Cancer With Occult PrimaryTongue CancerNCT00939627National Cancer Institute (NCI)55
已完成
2 期
Cetuximab + / - Carboplatin for Estrogen Receptor-Negative, Progesterone Receptor-Negative Metastatic Breast CancerBreast CancerNCT00232505UNC Lineberger Comprehensive Cancer Center112
已完成
2 期
Cetuximab & Celecoxib for Metastatic Colorectal Cancer or Colorectal Cancer That Cannot Be Removed by SurgeryColorectal CancerNCT00466505Vanderbilt-Ingram Cancer Center17