- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03204032
A Study of Tegafur Combined With Temozolomide Versus Tegafur Combined With Temozolomide and Thalidomide in Subjects With Advanced Extrapancreatic Neuroendocrine Tumor
A Phase II Randomized,Controlled,Open Label,Multicentre Study of Tegafur Combined With Temozolomide Versus Tegafur Combined With Temozolomide and Thalidomide in Subjects With Advanced Extrapancreatic Neuroendocrine Tumor
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100021
- Recruiting
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
-
Contact:
- Yihebali Chi, doctor
- Email: yihebalichi@yahoo.com.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients should participate in the study voluntarily and sign informed consent;
Histopathological proven diagnosis of low and intermediate grade (G1, G2 or G3) advanced Extrapancreatic neuroendocrine tumor( locally advanced, unresectable or distant Metastatic). For gastroenteropancreatic neuroendocrine tumor(GEP-NET),the
- Page 4 of 5 [DRAFT] - classification is based on nuclear mitotic number and the Ki-67 index,which are as follows:G1:Nuclear mitotic number <2/10HPF,Ki-67 proliferative index ≤2%.G2: Nuclear mitotic number 2~20/10HPF,Ki-67 proliferative index 3%~20%.G3 Nuclear mitotic number > 20/10HPF,Ki-67 proliferative index >20%;
- Patients with advanced Extrapancreatic neuroendocrine tumor who had not been treated or had no more than two kinds of Systemic Anti-tumor Therapy,which could be somatostatin analogs, interferon, PRRT (peptide receptor radionuclide therapy), mTOR inhibitors, or chemotherapy (without any use of azole amines, fluorouracil,or thalidomide chemotherapy drugs);
- Radiological documentation of tumor progression is required within 12months prior to randomization;
- At least one measurable lesion (byRECIST1.1);
ANC≥1.5×109/L,PLT≥100×109/L,HB≥90g/L,TBIL≤1.5ULN ;Without supportive care, ALT≤2.5ULN and ALP≤2.5ULN (without hepatic metastasis) ALT≤5ULN and ALP≤5ULN(with hepatic metastasis);serum creatin ≤1.5ULN and creatinine clearance rate
≥60ml/min;INR≤1.5ULN and APTT ≤1.5ULN ;
- ECOG PS:0-1;
- Life expectancy of more than 12 weeks;
- Men/Women of childbearing potential must agree to use a highly effective contraceptive method (such as double barrier contraceptive method,condom, oral or injectable contraceptives and intrauterine device) throughout treatment and for at least 90 days after study completion;All female patients will be considered fertile unless she has undergone natural menopause, artificial menopause or sterilization (such as hysterectomy, bilateral adnexal resection, or radioactive ovarian irradiation etc.)
Exclusion Criteria:
1、Diagnosed with high grade (G3) neuroendocrine carcinomas, adenocarcinoma, pancreatic islet cell carcinoma, goblet cell carcinoid, large cell neuroendocrine carcinoma, and small cell carcinoma; 2、Functional NET which needs concomiant use of long-acting somatostatin analogues to control symptoms such as insulinoma, gastrinoma, glucagon tumor, somatostatin, ACTH tumor, VIP tumor, and carcinoid syndrome, Zollinger-Ellison syndrome or other disease-specific active symptoms.
3、Have received anti-vascular endothelial growth factor(VEGF)/VEGFR targeted drugs and progressed upon these drugs 4、Urinalysis shows urine protein ≥ 2+ or 24-hour protein quantity test shows urinary protein ≥1 g; 5、Serum potassium, calcium (albumin-bound ionic or corrected) or magnesium exceed the normal range with clinical significance; 6、Under anti-hypertension treatment, still uncontrolled hypertension, defined as: systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg; 7、Gastrointestinal disease or condition that investigators suspect may affect drug absorption, including, but not limited to, active gastric and duodenal ulcers, ulcerative colitis and other digestive disease, gastrointestinal tumor with active bleeding, or other gastrointestinal conditions that may cause bleeding or perforation by investigator's discretion; 8、History or presence of a serious hemorrhage (>30 ml within 3 months), hemoptysis (>5 ml blood within 4 weeks) or a thromboembolic event (including transient ischemic attack) within 12 months; 9、Clinically significant cardiovascular disease, including but not limited to, acute myocardial infarction within 6 months prior to enrollment, severe/unstable angina pectoris or coronary artery bypass grafting, congestive heart failure according to the New York Heart Association (NYHA) classification ≥ 2; ventricular arrhythmias which needs drug treatment; LVEF (LVEF) <50%; 10、Mean corrected QT interval (QTc) ≥ 480 msec; 11、Other malignancies diagnosed within the previous 5 years, except basal cell carcinoma or cervical carcinoma in situ after radical resection; 12、Anti-tumor therapy received within 4 weeks prior to the initiation of the investigational treatment, including, but not limited to, chemotherapy, radical radiotherapy, targeted therapy, immunotherapy and anti-tumor Chinese medicine treatment, hepatic chemoembolization, cryoablation and radiofrequency ablation ; 13、Palliative radiotherapy for a bone metastasis lesion within 2 weeks prior to the initiation of the investigational treatment; 14、Any clinically significant active infection, including, but not limited to, human immunodeficiency virus (HIV) infection; 15、History of clinically significant hepatic disease, including, but not limited to, known hepatitis B virus (HBV) infection with HBV DNA positive (copies ≥1×104/ml); known Hepatitis C virus (HCV) infection with HCV RNA positive (copies ≥1×103/m); or liver cirrhosis, etc.
16、Surgery (except biopsy) within 28 days prior to the initiation of investigational treatment or unhealed surgical incision; 17、Brain metastases and/or spinal cord compression not treated by surgery and/or radiotherapy, and with no clinical imaging evidence of disease stability; 18、Toxicity from a previous anti-tumor treatment that does not return to Grade 0 or 1 (except for hair loss);
19、Received investigational treatments in other clinical studies within 4 weeks prior to enrollment; 20、Women who are pregnant or lactating; 21、Other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other conditions are inappropriate for the use of the investigational product or affect interpretation of study results.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tegafur and Temozolomide
|
Tegafur 40-60mg po bid(d1-d14);
200mg po qd(d10-d14)
|
Active Comparator: Tegafur and Temozolomide combined with Thalidomide
|
Tegafur 40-60mg po bid(d1-d14);
200mg po qd(d10-d14)
Thalidomide 100mg po qd(d1-d7) Thalidomide 200mg po qd(d8-d14) Thalidomide 300mg po qd(d15-d21)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Objective Response Rate(ORR)
Time Frame: From randomization,each 6 weeks or 12 weeks(a year later) up to intolerance to the toxicity or PD (up to 24 months)
|
From randomization,each 6 weeks or 12 weeks(a year later) up to intolerance to the toxicity or PD (up to 24 months)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to Tumor Response (TTR)
Time Frame: From randomization,each 6 weeks or 12 weeks(a year later)up to PD or death(up to 24 months)
|
From randomization,each 6 weeks or 12 weeks(a year later)up to PD or death(up to 24 months)
|
Duration of Response(DOR)
Time Frame: From randomization,each 6 weeks or 12 weeks(a year later) up to PD or death(up to 24 months)
|
From randomization,each 6 weeks or 12 weeks(a year later) up to PD or death(up to 24 months)
|
Progression free survival(PFS)
Time Frame: From randomization,each 6 weeks or 12 weeks(a year later)(a year later) up to PD or death (up to 24 months)
|
From randomization,each 6 weeks or 12 weeks(a year later)(a year later) up to PD or death (up to 24 months)
|
Disease Control Rate(DCR)
Time Frame: From randomization,each 6 weeks or 12 weeks(a year later) up to intolerable toxicity or PD (up to 24 months)
|
From randomization,each 6 weeks or 12 weeks(a year later) up to intolerable toxicity or PD (up to 24 months)
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Anti-Bacterial Agents
- Leprostatic Agents
- Thalidomide
- Temozolomide
- Tegafur
Other Study ID Numbers
- CH-GI-104
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Extrapancreatic Neuroendocrine Tumor
-
National Cancer Institute (NCI)RecruitingLocally Advanced Lung Neuroendocrine Neoplasm | Lung Neuroendocrine Neoplasm | Metastatic Lung Neuroendocrine Neoplasm | Recurrent Lung Neuroendocrine Neoplasm | Unresectable Lung Neuroendocrine Neoplasm | Advanced Lung Neuroendocrine Tumor | Functioning Lung Neuroendocrine Tumor | Lung Neuroendocrine... and other conditionsUnited States
-
National Cancer Institute (NCI)Active, not recruitingCarcinoid Tumor | Functioning Pancreatic Neuroendocrine Tumor | Intermediate Grade Lung Neuroendocrine Neoplasm | Locally Advanced Pancreatic Neuroendocrine Tumor | Locally Advanced Unresectable Digestive System Neuroendocrine Neoplasm | Low Grade Lung Neuroendocrine Neoplasm | Metastatic Digestive... and other conditionsUnited States
-
National Cancer Institute (NCI)RecruitingMetastatic Midgut Neuroendocrine Tumor | Unresectable Midgut Neuroendocrine Tumor | Metastatic Midgut Neuroendocrine Tumor G1 | Metastatic Midgut Neuroendocrine Tumor G2United States, Canada
-
National Cancer Institute (NCI)Active, not recruitingMetastatic Digestive System Neuroendocrine Tumor G1 | Metastatic Carcinoid Tumor | Recurrent Digestive System Neuroendocrine Tumor G1 | Regional Digestive System Neuroendocrine Tumor G1 | Midgut Neuroendocrine Tumor G1 | Foregut Neuroendocrine Tumor | Hindgut Neuroendocrine Tumor | Neuroendocrine...Canada, United States
-
National Cancer Institute (NCI)Active, not recruitingCarcinoid Tumor | Neuroendocrine Neoplasm | Colorectal Neuroendocrine Tumor G1 | Gastric Neuroendocrine Tumor G1 | Neuroendocrine Tumor G2United States
-
Dana-Farber Cancer InstituteMassachusetts General Hospital; Novartis; Beth Israel Deaconess Medical Center; Brigham and Women's HospitalCompletedNeuroendocrine Tumor | Carcinoid Tumor | Pancreatic Neuroendocrine TumorUnited States
-
Dana-Farber Cancer InstituteBayer; NovartisCompletedNeuroendocrine Tumor | Carcinoid Tumor | Pancreatic Neuroendocrine TumorUnited States
-
TaiRx, Inc.Active, not recruitingNeuroendocrine Tumors | Gastro-enteropancreatic Neuroendocrine Tumor | Neuroendocrine Carcinoma | Pancreatic Neuroendocrine Tumor | Lung Neuroendocrine NeoplasmTaiwan
-
University of Roma La SapienzaRecruitingNeuroendocrine Tumors | Neuroendocrine Carcinoma | Neuroendocrine Neoplasm | Neuroendocrine Tumor Grade 2 | Neuroendocrine Tumor Grade 1Italy
-
University of WashingtonEli Lilly and CompanyRecruitingLocally Advanced Unresectable Digestive System Neuroendocrine Neoplasm | Metastatic Digestive System Neuroendocrine Neoplasm | Pancreatic Neuroendocrine Tumor | Advanced Digestive System Neuroendocrine Neoplasm | Digestive System Neuroendocrine Tumor | Foregut Neuroendocrine Tumor | Hindgut Neuroendocrine... and other conditionsUnited States
Clinical Trials on Tegafur
-
Yokohama City UniversityUnknown
-
Zhejiang Cancer HospitalRecruitingNasopharyngeal CarcinomaChina
-
Chang Gung Memorial HospitalUnknownSquamous Cell Carcinoma of Oral CavityTaiwan
-
Guangzhou University of Traditional Chinese MedicineNot yet recruitingRectal Cancer | Colon Cancer | Metastasis Colorectal CancerChina
-
Institut Cancerologie de l'OuestMerck Sharp & Dohme LLCTerminatedRectal Cancer | Stage II/III | T3 or T4 (Only Anal Extension) Rectal Cancer | N0-2 | M0France
-
National Taiwan University HospitalUnknownStage II Colon Cancer | MSI-L/MSSTaiwan
-
Edelman, Martin, M.D.Bristol-Myers SquibbUnknownEsophageal NeoplasmUnited States
-
Urological Oncology Council of Northern TokyoUnknown
-
Fudan UniversityCompletedGastric Cancer
-
Taiho Pharmaceutical Co., Ltd.Completed