Phase II Trial of Sunitinib Malate (Sutent) Therapy in Patients With Advanced Non-Clear Cell Renal Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Number of Participants With Response to Treatment
研究概览
简要总结
The goal of this clinical research study is to learn the effectiveness of Sutent® (sunitinib malate, SU011248) in the treatment of patients with non-clear cell renal cell cancer. The safety of sunitinib malate will also be studied.
详细描述
Sunitinib malate is designed to block pathways that control important events such as the growth of blood vessels that are essential for the growth of cancer.
If you are found to be eligible to take part in this study, you will take sunitinib malate once a day (either with or without food) for 4 weeks in a row followed by 2 weeks of rest with no study drug. These 6 weeks are considered 1 cycle of study treatment.
Around Day 15 of each cycle, your vital signs will be measured and recorded, and you will have blood drawn (about 2 teaspoons) for routine testing. These evaluations can be done at your local doctor's office.
You will be required to return to clinic for a follow-up visit around Day 29 of Cycle 1.
At this visit, your medical history will be recorded, and your ability to perform daily activities will be evaluated. You will have a physical exam, including measurement of your vital signs. You will be asked about any side effects you may have experienced since your last visit. You will be asked about any medicines you may be currently taking. You will have blood drawn (about 4 teaspoons) for routine testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have histologically or cytologically confirmed advanced non-clear cell of one of the following subtypes: papillary, chromophobe, collecting duct carcinoma (CDC), renal medullary carcinoma (RMC), or unclassified. Patients with conventional-type renal cell carcinoma who have >/= 20% sarcomatoid component in their primary tumor are eligible. Patients who have sarcomatoid features in fine-needle aspiration (FNA) or core biopsy of any metastatic site are eligible.
- •Patients must have measurable disease.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Patients must have adequate organ and marrow function within 14 days prior to study entry as defined: Hemoglobin >/= 9 g/dl, absolute neutrophil count >/= 1,500/microliter (microL), platelets >/= 100,000/microL, total bilirubin </= 1.5 mg/dl, AST(SGOT) and/or ALT (SGPT) </= 2.5 X institutional uln, except in known hepatic metastasis, wherein may be </= 5 x uln, serum creatinine </= 4 X uln (as long as patient does not require dialysis).
- •Patients must have recovered from any effects of surgery.
- •Female patients of childbearing potential (not postmenopausal for at least 12 months and not surgically sterile) must have a normal plasma beta human chorionic gonadotropin (betaHCG) within 24 hours prior to enrolling in the study.
- •Patients of child fathering or childbearing potential must agree to practice a form of medically acceptable birth control while on study (barrier method, hormonal methods, etc.).
- •Patients must give written informed consent prior to initiation of therapy, in keeping with the policies of the institution. Patients with a history of major psychiatric illness must be judged (by the treating physician) able to fully understand the investigational nature of the study and the risks associated with the therapy.
- •Patients with brain metastases may participate in this trial.
- •Patients who have had up to two prior systemic therapies are eligible to participate in this trial but they should not have had prior Multi-Tyrosine Kinase Inhibitors such as sorafenib or sunitinib malate.
排除标准
- •No prior malignancy is allowed, except for non-melanoma skin cancer, in situ carcinoma of any site, or other cancers for which the patient has been adequately treated and disease free for 2 years.
- •Pregnant or lactating women are excluded.
- •Patients must not be scheduled to receive any experimental drug for MRCC while on study. Patients are permitted to be on concomitant bisphosphonates. Patients are permitted to receive hematopoietic growth factors according to American Society of Clinical Oncology (ASCO) guidelines.
- •Patients must not have had prior radiotherapy to areas of measurable disease, unless they have clearly progressive disease in this site, or there is measurable disease outside the area of prior radiation. Radiotherapy, if needed for palliation, must have been completed at least 2 weeks prior to enrollment on this study.
- •Patients may not have any significant medical disease (other than the malignancy) that, in the investigator's opinion, would increase the risk for participation. Examples of exclusion: unstable angina pectoris, New York Heart Association (NYHA) Grade II or greater congestive heart failure, unstable symptomatic cardiac arrhythmias requiring medication (subjects with controlled chronic atrial fibrillation are eligible), myocardial infarction within 6 months, uncontrolled HTN (blood pressure >150/90 on therapy), corrected QT interval (QTc) interval > 500msec or other significant ECG abnormalities or uncontrolled DM.
- •Patients must not have history of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of sunitinib malate or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.
- •Concomitant treatment with drugs with dysrhythmic potential (terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, and indapamide) is not recommended.
- •Patients unwilling to participate or unable to comply with the protocol for the duration of the study.
研究组 & 干预措施
Sunitinib Malate
Sunitinib Malate 50 mg by mouth daily for 4 weeks, then 2 weeks off.
干预措施: Sunitinib Malate (Drug)
结局指标
主要结局
Number of Participants With Response to Treatment
时间窗: Every 6 weeks for the first two cycles, then every 12 weeks, up to 2 years
Response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least 30% decrease in sum of the longest dimensions (LD) of all target lesions, taking as reference the baseline sum of LD. Stable Disease (SD): Insufficient shrinkage to qualify for partial response, or insufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started. Progressive Disease (PD): At least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Median Progression-Free Survival (PFS)
时间窗: Every 6 weeks for the first two cycles, then every 12 weeks, up to 2 years
Median Progression-Free Survival was calculated as the time from the date of the first treatment to the date of disease progression or date of death, or the last date of the outcome evaluation, whichever came first.
次要结局
- Median Overall Survival(Baseline till participant death or end of follow-up period, assessed every 6 weeks for the first two cycles, then every 12 weeks, up to 5 years.)