A Phase I/II Study to Evaluate the Optimum Dose of Pegylated-Interferon (PEG INTRON) in Patients With Platinum Resistant Ovarian, Peritoneal or Fallopian Tube Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Optimal Biologic Dose at 8 weeks
研究概览
简要总结
RATIONALE: PEG-interferon alfa-2b may interfere with the growth of cancer cells.
PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of PEG-interferon alfa-2b and to see how well it works in treating patients with ovarian epithelial, peritoneal, or fallopian tube cancer that is resistant to platinum-based chemotherapy.
详细描述
OBJECTIVES:
- Determine the optimum biologic dose of PEG-interferon alfa-2b in patients with platinum-resistant ovarian epithelial, peritoneal, or fallopian tube cancer.
- Determine the safety and tolerability of this drug in these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 different treatment arms.
- Arm I: Patients receive PEG-interferon alfa-2b (PEG IFN-α) subcutaneously (SC) on days 1, 8, 15, and 22.
- Arm II: Patients receive PEG IFN-α SC (at a higher dose than in arm I) on days 1, 8, 15, and 22.
- Arm III: Patients receive PEG IFN-α SC (at a higher dose than in arm II) on days 1, 8, 15, and 22.
In all arms, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
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
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with platinum-resistant epithelial ovarian, fallopian tube or peritoneal cancer whose tumor test positive for IL-8 (>31.0 pg/ml), bFGF >7.0 pg/ml), or VEGF (>700 pg/ml). Resistance is defined as:
- •Progression of disease during platinum chemotherapy, or
- •Progression of disease within 6 months of completing platinum chemotherapy
- •Failure to achieve a complete response, with persistent macroscopic disease, after 6 cycles of chemotherapy, if the last two cycles had no measurable change in disease status
- •Patients with a known hypersensitivity to platinum compounds who have failed a desensitization regimen, or who are not good candidates for desensitization are eligible.
- •Patients are limited to 4 prior chemotherapy regimens (all platinum and taxane regimens to be counted as one).
- •Patients must have measurable disease.
- •Women of any racial and ethnic group.
- •Zubrod performance status <
- •Expected survival of > 12 weeks.
- •Patients must have adequate hepatic, renal, and bone marrow function, defined as serum creatinine < 2 mg/dl (estimated creatinine clearance 50 ml/min); total bilirubin < 2.0 X the upper limit of normal (ULN); alanine aminotransferase (ALT) < 2X ULN; fasting triglycerides < 800 mg/dL; white blood count (WBC) > 3,000/mm3 ; absolute neutrophil count (ANC) > 1,500/mm3; platelets > 100,000/mm3, hemoglobin > 9 g/dl.
- •At least three weeks must have elapsed from completion of chemotherapy.
- •Patient agrees not to use complementary alternative medications (e.g., shark cartilage).
- •Patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with the policies of the hospital. The only approved consent is appended to this protocol.
排除标准
- •Patients with borderline, low grade or low malignant potential tumors are not eligible.
- •Patients who are pregnant or lactating.
- •Concurrent chemotherapy, radiation therapy or surgery.
- •Concurrent, uncontrolled, medical or psychiatric disorders.
- •Patients with a known hypersensitivity to interferon.
- •Patients with severe cardiovascular disease (i.e. arrhythmias requiring chronic treatment or congestive heart failure) (NYHA classification III or IV).
- •Patients who have had interferon within the last 6 months.
- •Patients with overt psychosis or mental disability or otherwise incompetent to give informed consent.
- •Patients with a known autoimmune disorder.
研究组 & 干预措施
PEG-interferon alfa-2b
Patients receive PEG-interferon alfa-2b (PEG IFN-α) subcutaneously (SC) on days 1, 8, 15, and 22.
干预措施: PEG-interferon alfa-2b (Biological)
Arm II
Patients receive PEG IFN-α SC (at a higher dose than in arm I) on days 1, 8, 15, and 22.
干预措施: PEG-interferon alfa-2b (Biological)
Arm III
Patients receive PEG IFN-α SC (at a higher dose than in arm II) on days 1, 8, 15, and 22.
干预措施: PEG-interferon alfa-2b (Biological)
结局指标
主要结局
Optimal Biologic Dose at 8 weeks
时间窗: 8 weeks
Optimum biologic dose of PEG Intron in patients with platinum-resistant ovarian, fallopian tube or peritoneal cancer whose tumors test positive for IL-8, BFGF, or VEGF.
Tumor Response
时间窗: Every 2 -3 cycles (8 - 12 weeks)
Each patient tumor response scored as either complete/partial response (CR/PR), stable disease (SD), or failure (F) at 8 weeks after initial treatment.
次要结局
未报告次要终点