Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Tegafur Combined With Temozolomide Versus Tegafur Combined With Temozolomide and Thalidomide in Subjects With Advanced Pancreatic Neuroendocrine Tumor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03204019
Recruitment Status : Unknown
Verified June 2017 by yihebali chi, Chinese Academy of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : June 29, 2017
Last Update Posted : June 29, 2017
Sponsor:
Information provided by (Responsible Party):
yihebali chi, Chinese Academy of Medical Sciences

Tracking Information
First Submitted Date  ICMJE June 28, 2017
First Posted Date  ICMJE June 29, 2017
Last Update Posted Date June 29, 2017
Actual Study Start Date  ICMJE October 2016
Estimated Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2017)
Objective Response Rate(ORR) [ Time Frame: From randomization,each 6 weeks or 12 weeks(a year later) up to intolerance the toxicity or PD (up to 24 months) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2017)
  • Disease Control Rate(DCR) [ Time Frame: From randomization,each 6 weeks or 12 weeks(a year later) up to intolerance the toxicity or PD (up to 24 months ]
  • 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) ]
  • 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) ]
  • 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) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Tegafur Combined With Temozolomide Versus Tegafur Combined With Temozolomide and Thalidomide in Subjects With Advanced Pancreatic Neuroendocrine Tumor
Official Title  ICMJE 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 Pancreatic Neuroendocrine Tumor
Brief Summary A Phase II Randomized,Controlled,Open Label,Multicentre Study to evaluate the efficacy and safety of Tegafur combined with Temozolomide versus Tegafur combined with Temozolomide and Thalidomide in subjects with Advanced Pancreatic Neuroendocrine Tumor
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Neuroendocrine Tumor
Intervention  ICMJE
  • Drug: Tegafur and Temozolomide
    Tegafur 40-60mg po bid(d1-d14); Temozolomide 200mg po qd(d10-d14)
  • Drug: Tegafur and Temozolomide combined with Thalidomide
    Tegafur 40-60mg po bid(d1-d14); Temozolomide 200mg po qe(d10-d14) Thalidomide 100mg po qd(d1-d7) /Thalidomide 200mg po qd(d8-d14)/Thalidomide 300mg po qd(d15-d21)
Study Arms  ICMJE
  • Experimental: Tegafur and Temozolomide
    Drugs should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
    Intervention: Drug: Tegafur and Temozolomide
  • Active Comparator: Tegafur and Temozolomide combined with Thalidomide
    Drugs should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
    Intervention: Drug: Tegafur and Temozolomide combined with Thalidomide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 28, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2018
Estimated Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients should participate in the study voluntarily and sign informed consent;
  2. Histopathological proven diagnosis of low and intermediate grade (G1, G2 or G3) advanced pancreatic neuroendocrine tumor( locally advanced, unresectable or distant Metastatic). For gastroenteropancreatic neuroendocrine tumor(GEP-NET),the 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%;
  3. Patients with advanced PNENs 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);
  4. Radiological documentation of tumor progression is required within 12 months prior to randomization;
  5. At least one measurable lesion (byRECIST1.1);
  6. 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 ;
  7. ECOG PS:0-1;
  8. Life expectancy of more than 12 weeks;
  9. 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、Gastrointestinal tract, lung and thymus, and other unknown source of neuroendocrine tumors; 3、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.; 4、prior use of any VEGF/VEGFR targeted drugs and with disease progression during treatment; 5、Urine protein ≥ ++,or Urine protein detected by quantitative test of 24h urinary protein>1.0 g; 6、Serum potassium and calcium (ionic or albumin binding) or magnesium exceed normal range and have clinical significance; 7、 Blood pressure unable to be stably controlled(systolic pressure>140 mmHg,diastolic pressure>90mmHg); 8、gastrointestinal diseases or states judged by Investigators that could affect the absorption of the drug, including but not limited to active gastric and duodenal ulcers, ulcerative colitis or other gastrointestinal diseases or unresectable gastrointestinal tumor with active bleeding or other status that may cause gastrointestinal bleeding or perforation; 9、Patients have or had severe hemorrhage (bleeding volume >30ml within 3 months) , hemoptysis( fresh blood >5ml within 4 weeks ) or thromboembolic events (including transient ischemic attack) within 12 months; 10、Cardiovascular disease with significant clinical significance, including but not limited to acute myocardial infarction, severe / unstable angina or coronary artery bypass surgery within 6 months prior to enrollment; congestive heart failure (New York Heart Association (NYHA) classification> 2); ventricular arrhythmia requiring pharmacological treatment; left ventricular ejection fraction (LVEF) <50%; 11、 Electrocardiogram (ECG) showed QT interval ≥480ms; 12、Patients suffered from other malignant tumors in the past 5 years,except radical resection of skin basal cells or squamous cell carcinoma, or cervical carcinoma in situ; 13、patients who have received anti-tumor therapy within 4 weeks prior to initiation of the study, including but not limited to chemotherapy, radiotherapy, bio-targeted therapy, immunotherapy, anti-tumor treatment of traditional Chinese medicine, hepatic artery embolization, hepatic metastatic cryoablation or radiofrequency ablation surgery; 14、patients who have received Palliative radiotherapy for bone metastaseswithin 2 weeks prior to initiation of the study ; 15、Any clinically significant active infection, including but not limited to HIV infection; 16、Patients with clinically significant liver disease history ,including but not limited to hepatitis B virus (HBV) infection (HBVDNA positive and copy number ≥1×104/ml); hepatitis C virus (HCV) infection,(HCVRNA positive and copy number≥1×103/ml), or cirrhosis; 17、Patients had surgery (except biopsy) within 28 days or has surgical incision not fully healed prior to initiation of the study; 18、Patients with brain metastasis or spinal cord compression which had not surgical and / or radiation therapy,or which had previous treatment but there is no clinical imaging evidence proving the condition is stable; 19、The toxic reaction of previous anticancer treatment has not restored to grade 0 or 1 (except hair loss); 20、Patients participated in other drug clinical trials within 4 weeks and received drug treatment ; 21、Pregnancy(Pregnancy test positive before drug use)or lactation; 22、any other disease, metabolic abnormality, abnormal physical examination, or laboratory abnormalities estimated by investigators that make the patients not suitable to receive the study drug or will affect the interpretation of the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03204019
Other Study ID Numbers  ICMJE CH-GI-103
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party yihebali chi, Chinese Academy of Medical Sciences
Study Sponsor  ICMJE Chinese Academy of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yihebali Chi, doctor Chinese Academy of Medical Sciences
PRS Account Chinese Academy of Medical Sciences
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP