NCT00033384已完成2 期
A Multicenter Phase 2 Study of CI-1040 In Patients With Advanced Nonsmall-Cell Lung Cancer, Breast Cancer, Colon Cancer Or Pancreatic Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: CI-1040 may stop the growth of tumors by blocking the enzymes necessary for cancer cell growth and by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of CI-1040 in treating patients who have metastatic or unresectable breast, colon, pancreatic, or non-small cell lung cancer.
详细描述
OBJECTIVES:
- Determine the antitumor activity of CI-1040 in patients with non-small cell lung, breast, colon, or pancreatic cancer.
- Determine the safety profile of this drug in these patients.
- Assess quality of life (overall and for each tumor type) of patients treated with this drug.
- Determine the relationship between study drug concentration and antitumor response in these patients and target suppression and safety of this drug.
- Correlate target suppression (pERK) with antitumor effects of this drug in these patients.
- Correlate the mRNA expression profile of the tumors with antitumor effects of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to tumor type (non-small cell lung vs breast vs colon vs pancreas).
Patients receive oral CI-1040 twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and then every 28 days during the first 6 months of study therapy.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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 metastatic or inoperable non-small cell lung, breast, or colon cancer or duct cell carcinoma of the exocrine pancreas
- •Bidimensionally measurable lesions that are not previously irradiated
- •New lesions that have developed in a previously irradiated field may be used as measurable disease
- •No brain metastases
- •Patients with prior brain metastases are allowed provided they have undergone prior resection of metastases and/or 1 prior course of cranial irradiation, have no new sites of brain metastases since then, have no worsening CNS symptoms, and have discontinued prior corticosteroids for at least 30 days
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Not specified
- •Menopausal status:
- •Not specified
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 2 times upper limit of normal (ULN)
- •AST or ALT no greater than 2 times ULN (5 times ULN if due to liver involvement)
- •Creatinine no greater than 1.5 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 30 days after study participation
- •Capable of swallowing intact study medication capsules
- •Capable of following instructions regarding study medication or has daily caregiver to administer study medication
- •No concurrent serious infection
- •No life-threatening illness unrelated to tumor
- •No other prior or concurrent malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 2 weeks since prior immunotherapy or biologic therapy
- •Chemotherapy:
- •At least 4 weeks since prior cytotoxic chemotherapy
- •No more than 1 prior cytotoxic chemotherapy regimen for metastatic non-small cell lung or colon cancer
- •No more than 2 prior cytotoxic chemotherapy regimens for breast cancer
- •No prior cytotoxic chemotherapy for pancreatic cancer
- •Endocrine therapy:
- •See Disease Characteristics
- •At least 2 weeks since other prior hormonal therapy
- •Radiotherapy:
- •See Disease Characteristics
- •At least 3 weeks since prior radiotherapy and recovered
- •No concurrent radiotherapy
- •See Disease Characteristics
- •No other concurrent anticancer agents
排除标准
- 未提供
研究者
研究点 (1)
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