A Phase II Study of Sulindac and Tamoxifen in Patients With Desmoid Tumors That Are Recurrent or Not Amenable to Standard Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Percentage of Patients Failure Free at 2 Years Following Study Entry
研究概览
简要总结
This phase II trial is studying how well giving sulindac together with tamoxifen works in treating patients with desmoid tumor. Sulindac may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Hormone therapy using tamoxifen may fight cancer by blocking the use of estrogen. Combining sulindac with tamoxifen may kill more cancer cells.
详细描述
PRIMARY OBJECTIVES:
I. To estimate the safety and efficacy of sulindac and tamoxifen in patients with recurrent desmoid tumor (DT) and primary DT that is not readily amenable to surgery or radiation therapy.
SECONDARY OBJECTIVES:
I. Determine the tumor response rate in patients treated with this regimen.
II. Correlate changes in Magnetic Resonance Imaging (MRI) signal features of the tumor with clinical outcome in patients treated with this regimen.
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
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed desmoid tumor, meeting 1 of the following criteria:
- •Newly diagnosed disease
- •Not previously treated
- •Not amenable to complete surgical resection and/or radiotherapy
- •If surgical resection was attempted, there must be gross residual disease measurable by MRI
- •Radiographically documented recurrent or progressive disease
- •No prior chemotherapy or radiotherapy for the present recurrence
- •Tumors that progressed on prior chemotherapy are allowed provided patients have not received chemotherapy for this recurrence
- •Measurable disease by gadolinium-enhanced MRI
- •No other fibroblastic lesions or fibromatoses
- •Lipofibromatosis or desmoplastic fibroma of the bone allowed
- •Performance status - Karnofsky Score 50-100% (patients over age 16)
- •Performance status - Lansky Score 50-100% (patients age 16 and under)
- •At least 8 weeks
- •Absolute neutrophil count at least 1,000/mm^3
- •Platelet count at least 100,000/mm^3 (transfusion independent)
- •Hemoglobin at least 10.0 g/dL (transfusion allowed)
- •No hemophilia
- •No von Willebrand disease
- •No other clinically significant bleeding diathesis
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •Alanine aminotransferase (ALT) less than 2.5 times ULN
- •Creatinine adjusted according to age as follows:
- •No greater than 0.4 mg/dL (≤ 5 months)
- •No greater than 0.5 mg/dL (6 months -11 months)
- •No greater than 0.6 mg/dL (1 year-23 months)
- •No greater than 0.8 mg/dL (2 years-5 years)
- •No greater than 1.0 mg/dL (6 years-9 years)
- •No greater than 1.2 mg/dL (10 years-12 years)
- •No greater than 1.4 mg/dL (13 years and over [female])
- •No greater than 1.5 mg/dL (13 years to 15 years [male])
- •No greater than 1.7 mg/dL (16 years and over [male])
- •Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
- •No prior deep venous thrombosis
- •Electrocardiogram (EKG) normal
- •Chest x-ray normal
- •No prior significant gastrointestinal hemorrhage
- •No prior peptic ulcer disease
- •Not pregnant or nursing
- •Fertile patients must use effective nonhormonal contraception
- •No evidence of active graft-versus-host disease
- •No allergy to aspirin
- •Recovered from prior immunotherapy
- •At least 7 days since prior anticancer biologic agents
- •At least 6 months since prior allogeneic stem cell transplantation
- •More than 1 week since prior growth factors
- •No concurrent immunomodulating agents
- •No prior nonsteroidal anti-inflammatory drugs (NSAIDs) for desmoid tumor
- •More than 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered
- •No concurrent anticancer chemotherapy
- 另有 8 项未显示
排除标准
- 未提供
研究组 & 干预措施
Treatment (enzyme inhibitor therapy, anti-estrogen therapy)
Patients receive oral sulindac and oral tamoxifen citrate twice daily for up to 12 months (four 3-month courses) in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 1 additional month of treatment beyond documentation of CR.
干预措施: tamoxifen citrate (Drug)
Treatment (enzyme inhibitor therapy, anti-estrogen therapy)
Patients receive oral sulindac and oral tamoxifen citrate twice daily for up to 12 months (four 3-month courses) in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 1 additional month of treatment beyond documentation of CR.
干预措施: sulindac (Drug)
Treatment (enzyme inhibitor therapy, anti-estrogen therapy)
Patients receive oral sulindac and oral tamoxifen citrate twice daily for up to 12 months (four 3-month courses) in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 1 additional month of treatment beyond documentation of CR.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Percentage of Patients Failure Free at 2 Years Following Study Entry
时间窗: Up to 2 years
Kaplan Meier estimate of failure free survival at 2 years, where failure free survival is defined as the time to relapse, progression, second malignancy, and death whichever occurs first.
Percentage of Patients Experiencing a Grade 3 or Higher Adverse Event During Therapy.
时间窗: Up to 12 months
The percentage of patients experiencing a grade 3 or higher adverse event as assessed by the National Cancer Institute Common Toxicity Terminology for Adverse Events v3.0
次要结局
- Percentage of Patients With Tumor Response From Imaging(Baseline up to 5 years)
- Mean Change in Response Measured by MRI(From baseline to up to 5 years)
- Percentage of Patients Failure Free at 2 Years by Pathological Response(From enrollment to up to 2 years)
- Percentage of Patients Experiencing Short-term Endocrine Toxicity(At study entry)