NCT00603863已完成1 期
A Phase Ib/II Study of Fractionated 90Y-hPAM4 Plus Gemcitabine in Patients With Previously Untreated Advanced Pancreatic 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
- 80
- 试验地点
- 11
- 主要终点
- safety will be evaluated based upon physical examinations, hematology and chemistry laboratory testing as well as toxicity
研究概览
简要总结
This is a study to test whether different doses of 90Y-hPAM4 are safe to give in combination with gemcitabine in patients with previously untreated pancreatic cancer.
详细描述
Patients receive a 4-week treatment cycle with once-weekly 30-minute gemcitabine infusions beginning one week prior to the first 90Y-hPAM4dose and continuing during the 3 consecutive weeks over which once weekly 90Y-hPAM4 doses are given. Depending on toxicity, patient cohorts will receive one of several possible 90Y and gemcitabine dose combinations. Post-treatment evaluations conducted until instituting another 90YhPAM4 treatment cycle, maintenance gemcitabine or for a maximum period of 12 weeks.
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
- •Male or female patients, >18 years of age, who are able to understand and give written informed consent.
- •Histologically or cytologically confirmed pancreatic adenocarcinoma.
- •Stage III (locally advanced, unresectable) or Stage IV (metastatic) disease, including patients who underwent surgery but had incomplete resections.
- •Treatment naïve (no prior chemotherapy, radiotherapy or investigational agents for pancreatic cancer)
- •Karnofsky performance status > 70 % (Appendix A).
- •Expected survival > 3 months.
- •At least 4 weeks beyond major surgery and recovered from all acute toxicities
- •At least 2 weeks beyond corticosteroids, except low doses (i.e., 20 mg/day of prednisone or equivalent) to treat nausea or other illness such as rheumatoid arthritis
- •Adequate hematology without ongoing transfusional support (hemoglobin > 11 g/dL, ANC > 2,000 per mm3, platelets > 150,000 per mm3)
- •Adequate renal and hepatic function (creatinine and bilirubin ≤ 1.5 X IULN, AST and ALT ≤ 2.0 X IULN)
- •Otherwise, all toxicity at study entry <Grade 1 by NCI CTC v3.0.
排除标准
- •Women who are pregnant or lactating.
- •Women of childbearing potential and fertile men unwilling to use effective contraception during study until conclusion of 12-week post-treatment evaluation period.
- •Known metastatic disease to the central nervous system.
- •Presence of bulky disease (defined as any single mass >10 cm in its greatest dimension)
- •Patients with >Grade 2 anorexia, nausea or vomiting, and/or signs of intestinal obstruction.
- •Prior radiation dose >3,000 cGy to the liver, >2,000 cGy to lungs and kidneys or prior external beam irradiation to a field that includes more than 30% of the red marrow.
- •Patients with non-melanoma skin cancer or carcinoma in situ of the cervix are not excluded, but patients with other prior malignancies must have had at least a 5-year disease free interval.
- •Patients known to be HIV positive, hepatitis B positive, or hepatitis C positive.
- •Known history of active coronary artery disease, unstable angina, myocardial infarction, or congestive heart failure present within 6 months or cardiac arrhythmia requiring anti-arrhythmia therapy.
- •Known history of active COPD, or other moderate-to-severe respiratory illness present within 6 months.
- •Known autoimmune disease or presence of autoimmune phenomena (except rheumatoid arthritis requiring only low dose maintenance corticosteroids).
- •Infection requiring intravenous antibiotic use within 1 week.
- •Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
研究组 & 干预措施
multiple dose levels
Experimental
1 of 3 different dose levels of 90Y-hPAM4 given once weekly for 3 weeks along with 4 weekly doses of gemcitabine.
干预措施: IMMU-107 (hPAM4) (Biological)
结局指标
主要结局
safety will be evaluated based upon physical examinations, hematology and chemistry laboratory testing as well as toxicity
时间窗: over 12 weeks
次要结局
- Efficacy and Clinical benefit measures such as quality of life, pain assessments, etc.(over 5 years)
研究者
研究点 (11)
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