NCT00293501Unknown1 期
A Phase I/II Trial of Tinzaparin (Innohep), a Low Molecular Weight Heparin (LMWH) for Treatment of Advanced Renal Cell Carcinoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 35
- 试验地点
- 3
- 主要终点
- Blood markers or coagulation as measured by plasma prothrombin F1.2, thrombin-antithrombin complexes, and D-dimers at 2 weeks, 2 months and 6 months
研究概览
简要总结
RATIONALE: Tinzaparin may stop the growth of kidney cancer by blocking blood flow to the tumor.
PURPOSE: This phase I/II trial is studying the side effects of tinzaparin and to see how well it works in treating patients with metastatic kidney cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Determine the effect of tinzaparin sodium on fibrin formation (prothrombin fragment F1.2), thrombin generation (thrombin-antithrombin complexes), and fibrinolysis (D-Dimer) from baseline to 2 weeks and at nadir or disease progression in patients with unresectable metastatic renal cell carcinoma (RCC).
Secondary
- Determine the effect of tinzaparin sodium treatment on circulating angiogenesis markers, including vascular endothelial growth factor (VEGF) and basic fibroblast growth factor (bFGF).
- Determine the proportion of patients developing venous thromboembolism and hemorrhage.
- Determine the tolerability of tinzaparin sodium treatment for up to 6 months in these patients.
- Establish the feasibility of undertaking a multicenter renal cell carcinoma trial with specialized coagulation test collection, shipping, and processing.
- Obtain more accurate and specific mean, median, and variability in biomarker data in advanced RCC patients treated with tinzaparin sodium for purposes of planning larger future trials.
- Estimate the progression-free survival at 4 months in patients treated with tinzaparin sodium.
- Correlate progression-free survival with changes in markers of coagulation activation or angiogenesis.
- Correlate the anticoagulant activity of tinzaparin sodium (anti-Xa activity) with change in coagulation markers, angiogenesis markers, and progression-free survival.
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed renal cell carcinoma of clear cell histology
- •Tumors of mixed histology eligible if ≥ 50% of tumor has clear cell histology
- •No nonclear cell histologies, collecting duct tumors, oncocytomas, or transitional cell tumors
- •Metastatic and unresectable disease that is clinically extending beyond the regional lymph nodes (histological confirmation not required)
- •Patients who are inoperable for their primary tumor representing the sole site of disease are ineligible
- •Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 2 cm by conventional techniques OR ≥ 1 cm by spiral CT scan
- •No known brain metastases
- •PATIENT CHARACTERISTICS:
- •Expected survival > 2 months
- •CALGB (ECOG/ZUBROD) performance status (PS) 0-2 OR Karnofsky PS 60-100%
- •Hemoglobin ≥ 10 g/dL
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •AST/ALT ≤ 1.5 times ULN
- •Creatinine ≤ 1.5 times ULN
- •INR ≤ 1.5 times control value
- •PTT < 1.5 times control value
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Patients must be able to receive subcutaneous injections at home
- •No other primary malignancy in the past 5 years other than basal cell carcinoma or carcinoma in situ of the cervix that has been curatively treated and is associated with a less than 30% risk of relapse in the next 5 years
- •No signs or symptoms of bleeding within 4 the past weeks
- •No known bleeding diathesis or high risk for bleeding due to any condition, including trauma within the past 4 weeks, active current bleeding, or hemorrhagic stroke or intraocular bleeding within the past 6 months
- •No active thromboembolism highly likely to require anticoagulation during the study period
- •No known or suspected history of type II heparin-induced thrombocytopenia
- •No allergy or hypersensitivity to heparin, tinzaparin sodium, pork products, sulfite, or benzyl alcohol
- •No uncontrolled severe intercurrent illness, including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •No uncontrolled arterial hypertension, history of gastrointestinal ulceration, and/or bleeding in the past 4 weeks
- •No diabetic retinopathy or history of retinal hemorrhage
- •Not pregnant or nursing
- •HIV-positive patients are allowed
- •PRIOR CONCURRENT THERAPY:
- •No treatment with anticoagulation lasting > 1 month in the past 6 months
- •No anticoagulation, including treatment with a low molecular weight heparin, at any time within the past month
- •More than 4 weeks since prior surgery, radiation therapy, immunotherapy, or chemotherapy
- •Recovered from prior therapy
- •No other concurrent investigational agents
- •No other concurrent anticoagulation therapy, including oral anticoagulants, thrombolytic agents, or any form of heparin
- •Concurrent antiplatelet agents allowed
- •No spinal or epidural puncture, anesthesia, or post-operative indwelling epidural catheters within the past 48 hours
- •No other concurrent anticancer agents or therapies
- •No concurrent sex hormones except for postmenopausal hormone replacement
- •No concurrent chemotherapy or immunotherapy
- •No concurrent palliative radiotherapy
- •Concurrent urgent use of corticosteroids allowed
排除标准
- 未提供
结局指标
主要结局
Blood markers or coagulation as measured by plasma prothrombin F1.2, thrombin-antithrombin complexes, and D-dimers at 2 weeks, 2 months and 6 months
次要结局
- Blood markers of angiogenesis as measured by serum vascular endothelial growth factor (VEGF) and basic fibroblast growth factor (bFGF) at 2 weeks, 2 months, and 6 months
- Progression free survival as measured by clinical evaluation at 4 months
- Venous thromboembolism as measured by clinical evaluation at 6 months
研究者
研究点 (3)
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