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

June 28, 2017 updated by: yihebali chi, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Tegafur and Temozolomide
Drugs should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Drug: Tegafur and Temozolomide
Tegafur 40-60mg po bid(d1-d14); Temozolomide 200mg po qd(d10-d14)
ACTIVE_COMPARATOR: Tegafur and Temozolomide combined with Thalidomide
Drugs should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
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)

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 the toxicity or PD (up to 24 months)
From randomization，each 6 weeks or 12 weeks(a year later) up to intolerance the toxicity or PD (up to 24 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2016

Primary Completion (ANTICIPATED)

October 1, 2017

Study Completion (ANTICIPATED)

September 1, 2018

Study Registration Dates

First Submitted

June 28, 2017

First Submitted That Met QC Criteria

June 28, 2017

First Posted (ACTUAL)

June 29, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 29, 2017

Last Update Submitted That Met QC Criteria

June 28, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CH-GI-103

Drug and device information, study documents

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

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.

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