NCT02961374已完成2 期
Phase II Trial of Weekly Erlotinib Dosing to Reduce Duodenal Polyp Burden Associated With Familial Adenomatous Polyposis
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 8
- 主要终点
- Mean Percent Change in Duodenal Polyp Burden
研究概览
简要总结
This phase II trial studies the side effects of erlotinib hydrochloride and how well it works in reducing duodenal polyp burden in patients with familial adenomatous polyposis at risk of developing colon cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
详细描述
PRIMARY OBJECTIVES:
I. To assess the mean percent change in duodenal polyp burden (sum of diameters from all polyps) from baseline to 6 months post-intervention for familial adenomatous polyposis (FAP) subjects receiving weekly erlotinib hydrochloride (erlotinib).
II. To assess the grade 2/3 adverse event rate in this population and compare it to historical data.
SECONDARY OBJECTIVES:
I. To evaluate all adverse events at least possibly attributed to weekly erlotinib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PRE-REGISTRATION INCLUSION
- •Diagnosis of familial adenomatous polyposis (FAP) or attenuated familial adenomatous polyposis (AFAP), defined as at least one of the following:
- •Genetic diagnosis with confirmed APC mutation (Clinical Laboratory Improvement Act [CLIA] certified lab or research testing)
- •Obligate carrier
- •Clinical diagnosis of classic FAP with >= 100 colorectal adenomas status post colectomy and a family history of FAP
- •Clinical diagnosis of FAP, based on personal and family history; Note: This criterion requires documented review and agreement from either the study chair or the Cancer Prevention Network (CPN) lead investigator
- •Ability to understand and the willingness to sign a written informed consent document
- •Willing to discontinue taking nonsteroidal anti-inflammatory drugs (NSAIDS) for 30 days prior to initiation of and during intervention; exception: use of =< 81 mg daily or =< 650 mg weekly aspirin is allowed
- •Willing to discontinue smoking for the duration of study intervention
- •Willing to provide mandatory biospecimens as specified in the protocol
- •REGISTRATION INCLUSION
- •Eastern Cooperative Oncology Group (ECOG) performance status =< 1
- •Leukocytes (white blood cells [WBC]) >= 3,000/uL (>= 2,500/uL for African-American participants)
- •Platelet count >= 100 x 10^9/L
- •Hemoglobin >= 11.5 g/dL
- •Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
- •Alkaline phosphatase =< 1.5 x institutional upper limit of normal (ULN)
- •Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) =< 2 x institutional upper limit of normal (ULN)
- •Alanine aminotransferase (ALT)/serum glutamate pyruvate transaminase (SGPT) =< 2 x institutional upper limit of normal (ULN)
- •Creatinine =< institutional upper limits of normal (ULN)
- •Urinary testing results within institutional limits of normal or deemed clinically insignificant
- •Spigelman 2-3
- •Not pregnant or breast feeding; Note: the effects of erlotinib (Tarceva ) on the developing human fetus at the recommended therapeutic dose are unknown; for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately; breastfeeding should be discontinued if the mother is treated with erlotinib
- •Willing to use adequate contraception to avoid pregnancy or impregnation until 2 weeks after discontinuing study agent
排除标准
- •PRE-REGISTRATION EXCLUSION
- •Any prior treatment with erlotinib or other agent whose primary mechanism of action is known to inhibit EGFR
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib
- •Use of potent CYP3A4 inhibitors, including but not limited to ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole, and grapefruit or grapefruit juice
- •Use of potent CYP3A4 inducers, including but not limited to rifampicin, rifabutin, rifapentine, phenytoin, carbamazepine, phenobarbital, and St. John's wort
- •Use of any other investigational agents =< 12 weeks prior to pre-registration
- •Uncontrolled intercurrent illness or recent surgical procedure that in the opinion of the investigative team would limit compliance with study requirements, including, but not limited to:
- •Ongoing or active infection
- •Symptomatic congestive heart failure
- •Myocardial infarction =< 6 months prior to intervention
- •Severely impaired lung function
- •Nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with study intervention
- •Diagnosed liver disease, such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis
- •Unstable angina pectoris
- •Cardiac arrhythmia
- •Psychiatric illness/social situations
- •History of invasive malignancy =< 3 years prior to pre-registration; exception: adequately treated carcinoma of the cervix, carcinoma in situ, or basal or squamous cell carcinomas of the skin
- •Individuals on anticoagulation medications who cannot safely discontinue the medication for at least 48 hours prior to the study endoscopy, as determined by the study investigator and/or participant's primary healthcare provider
- •History of any upper gastrointestinal (GI) surgery that does not permit access to or evaluation of a 10 cm segment of the duodenum that includes the duodenal bulb, i.e. Whipple procedure or similar
- •REGISTRATION EXCLUSION
- •Histologically-confirmed high grade dysplasia (HGD), cancer, or polyp burden that is not quantifiable
- •Regular (>= 2 times per week) use of drugs that alter the pH of the gastrointestinal tract (GI) tract, such as proton pump inhibitors (PPI) and antacids; exceptions: individuals who use prescription PPIs and have approval from their primary health care provider to replace the PPI with an H2 receptor agonist, i.e. ranitidine, for the duration of the trial will be eligible
- •Gastrointestinal bleeding; note that the presence of any symptoms (dyspnea, fatigue, angina, weakness, malaise, melena, hematochezia, hematemesis, anemia, abdominal pain) will require clinical assessment to rule out gastrointestinal bleeding
研究组 & 干预措施
Treatment (erlotinib hydrochloride)
Experimental
Patients receive erlotinib hydrochloride PO once weekly. Treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity.
干预措施: Erlotinib (Drug)
Treatment (erlotinib hydrochloride)
Experimental
Patients receive erlotinib hydrochloride PO once weekly. Treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity.
干预措施: Erlotinib Hydrochloride (Drug)
结局指标
主要结局
Mean Percent Change in Duodenal Polyp Burden
时间窗: Baseline to 6 months post-intervention
Assessed by esophagogastroduodenoscopy, the mean percent change was calculated by subtracting the sum of diameters from all polyps at baseline from the sum of diameters of all polyps at 6 months, then dividing by the sum of diameters from all polyps at baseline and multiplying by 100.
Number of Participants With Grade 2/3 Adverse Event (AE)
时间窗: Up to 7 months from registration
Assessed according to National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The number of patients reporting a grade 2 or higher event are reported.
次要结局
- Absolute Change in Lower Gastrointestinal Polyp Burden(Baseline to 6 months)
- Percent Change in Lower Gastrointestinal Polyp Burden(Baseline to 6 months)
- Absolute and Percent Change in Desmoid Tumor Size(Baseline to 6 months)
- Absolute Change in Lower Gastrointestinal Polyp Number(Baseline to 6 months)
- Percent Change in Lower Gastrointestinal Polyp Number(Baseline to 6 months)
- Number of Participants With Any Adverse Events(Up to 7 months from registration)
- Change in Duodenal Polyp Number(Baseline to 6 months)
研究者
研究点 (8)
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