A Pilot Study of Dovitinib as Maintenance and Adjuvant Therapy in Patients With Colorectal and Pancreas Cancers
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Biomarker Discovery
研究概览
简要总结
This study is for patients with stage 4 colon cancer who have had initial chemotherapy or had surgery to remove metastases and patients with pancreas cancer, which has been surgically removed and are receiving adjuvant chemotherapy or is locally advanced and have already received chemotherapy and radiation.
The purpose of this study is to determine the effects of oral dovitinib in patients with advanced stage colorectal and pancreas. Effects include biomarker changes, progression-free survival and safety. Dovitinib will be taken by mouth for 5 days out of every week for up to 2 years.
详细描述
This is a single institution, nonrandomized, open-label pilot study of dovitinib as maintenance and adjuvant therapy in patients with colorectal and pancreas cancers.
Patient Populations:
Cohort 1: Stage 4 Colon Cancer s/p metastasectomy (Adjuvant cohort)
Cohort 2: Stage 4 Colon Cancer after initial chemotherapy (Maintenance cohort)
Cohort 3: Pancreas Cancer s/p resection and adjuvant chemo (Adjuvant cohort)
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a confirmed diagnosis of:
- •Stage 4 colon cancer either s/p metastasectomy or post-initial chemotherapy or maintenance "standard of care", either involving 5-fluorouracil/leucovorin (5-FU/LV) alone or continual bevacizumab alone. Patients in maintenance cohort must have had 2 consecutive CT scans showing stable disease and not be experiencing significant prior treatment-related toxicity above Grade
- •Pancreas cancer, either s/p resection and adjuvant chemotherapy or locally advanced pancreas cancer s/p chemotherapy and radiation. Initial chemotherapy or radiation therapy may have been stopped between 2 weeks and 2 months prior to study start, and patients must have recovered from prior treatment related toxicity to grade 1 or less.
- •Prior surgery, including tumor resection or metastasectomy must have been performed at least 4 weeks prior to study enrollment.
- •No concomitant anti-cancer treatment is allowed
- •Age >/= 18 years
- •Performance status of 0-1
- •Adequate hepatic, bone marrow, and renal function
- •Partial thromboplastin time (PTT) must be </= 1.5 x upper normal limit of institution's normal range and INR (International Normalized Ratio) < 1.
- •Life expectancy >/= 4 months for maintenance cohorts and >/= 6 months for adjuvant cohorts
- •Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment and must not be lactating.
- •Subject is capable of understanding and complying with protocol demands and able to sign and date the informed consent
排除标准
- •Women of child-bearing potential, who are biologically able to conceive, not employing two forms of highly effective contraception or who are pregnant.
- •Women who are breast-feeding
- •Fertile males unwilling to use contraception
- •Patients with brain metastases or any history of brain metastases
- •Patients who have undergone major surgery (e.g., intra-thoracic, -abdominal, or -pelvic) </= 4 weeks prior to starting study treatment or who have not recovered from such therapy
- •Patients with a history of pulmonary embolism, or untreated deep vein thrombosis within the past 6 months
- •Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of dovitinib
- •The subject has had another active malignancy within the past 5 years except for cervical cancer in situ, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin.
- •Patients who have received the last administration of an anticancer therapy including chemotherapy, immunotherapy, hormonal therapy and monoclonal antibodies </= 2 weeks prior to starting the study drug, or who have not recovered from the side effects of such therapy
- •Cirrhosis, chronic active hepatitis or chronic persistent hepatitis
- •Patients who are currently receiving prasugrel
- •No concurrent use of isoniazid, labetolol, trovafloxacin, tolcapone, and felbamate
- •No concurrent use of other investigational drugs or antineoplastic therapies.
- •Patients with impaired cardiac function or clinically significant cardiac diseases.
研究组 & 干预措施
Dovitinib
Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years
干预措施: Dovitinib (Drug)
结局指标
主要结局
Biomarker Discovery
时间窗: 2 years
Changes in biomarkers from before treatment compared to during or after treatment: expression of pFGFR, pFRS2, pERK, BFGF, VEGF, FGFR1, FGFR2,VEGFR, Ki-67, Asp175, and CA9 in tumor tissue; FGFR, VEGFs, BFGF, PLGF, sVEGFR1/ 2, FGF23, GCSF, PDGF-AB, SDF-1a and SCF levels in serum
次要结局
- Progression-free Survival(2 years)
- Safety(2 years)