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TEMCAP in Grade 3 and Low Ki-67 Gastroenteropancreatic Neuroendocrine Tumors

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03079440
Recruitment Status : Recruiting
First Posted : March 14, 2017
Last Update Posted : June 16, 2020
Information provided by (Responsible Party):
Baek-Yeol Ryoo, Asan Medical Center

Brief Summary:
GI tract including pancreas is the one of most common primary sites of neuroendocrine tumors. Current grading of neuroendocrine tumors are based on the 2010 WHO classification. This classifies grade 3 tumors as the neuroendocrine tumor with mitosis > 20 per 10 high power field or Ki-67 labeling index > 20%. Etoposide-based chemotherapy, mostly as the combination with cisplatin, has been the mainstay of the treatment for patients with grade 3 neuroendocrine tumors. However, a recent large retrospective analysis has suggested this regimen may not be effective in relatively low Ki-67 labeling index. Therefore, the investigators designed a clinical trial testing temozolomide-capecitabine combination, which has been mostly investigated in well differentiated (ie., grade 1 or 2) neuroendocrine tumors, in patients with grade 3 and low Ki-67 gastroenteropancreatic neuroendocrine tumors.

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Neuroendocrine Carcinoma Temozolomide Capecitabine Drug: TEMCAP Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 31 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Temozolomide Plus Capecitabine in Patients With Grade 3 and Low Ki-67 Gastroenteropancreatic Neuroendocrine Tumors
Actual Study Start Date : May 15, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : October 2021

Arm Intervention/treatment
Experimental: TEMCAP
Temozolomide plus Capecitabine
Oral capecitabine 750 mg/m2 twice a day, Day 1 to 14 and oral temozolomide 200 mg/m2 once a day, Day 10 to 14
Other Name: Temozolomide and capecitabine

Primary Outcome Measures :
  1. Response rate [ Time Frame: 2 years ]
    Proportion of patients with complete or partial response graded by Response Evaluation Criteria in Solid Tumors version 1.1

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 2 years ]
    Time between the start of study treatment and disease progression

  2. Overall survival [ Time Frame: 2 years ]
    Time between the start of study treatment and survival

  3. Toxicity (Adverse events graded by National Cancer Institute-Common Terminology Criteria version 4.03) [ Time Frame: 2 years ]
    Adverse events graded by National Cancer Institute-Common Terminology Criteria version 4.03

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients aged 19 years and older
  • Histologically confirmed neuroendocrine tumors of gastrointestinal tract or pancreas
  • Unresectable or metastatic disease
  • Grade 3 according to the 2010 WHO classification (Ki-67 labeling index > 20% or > 20 mitoses per 10 high power field)
  • Ki-67 labeling index < 60%
  • At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors version 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 ~ 2
  • Adequate bone marrow function as defined by platelets ≥ 100 x 109/L and neutrophils ≥ 1.5 x 109/L
  • Adequate renal function, with serum creatinine < 1.5 x upper limit of normal (ULN)
  • Adequate hepatic function with serum total bilirubin < 2 mg/dL, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 2.5 x ULN
  • No other malignant disease apart from non-melanotic skin cancer or carcinoma in situ of the uterine cervix or any other non life-threatening cancer (i.e., prostate or thyroid cancer) except where treated with curative intent > 5 years previously without evidence of relapse
  • Written informed consent to the study

Exclusion Criteria:

  • Medical or psychiatric conditions that compromise the patient's ability to give informed consent or to complete the protocol or a history of non-compliance
  • Last dose of radiotherapy received within 4 weeks before the start of study treatment, excluding palliative radiotherapy
  • Obstruction of gastrointestinal tract
  • Active gastrointestinal bleeding
  • Myocardial infarction within 6 months prior to the study medication, and other clinically significant heart disease (e.g., unstable angina, congestive heart failure or uncontrolled hypertension)
  • Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardise compliance with the protocol
  • Female subjects who are pregnant or lactating, or males and females of reproductive potential not willing or not able to employ a highly effective method of birth control/contraception to prevent pregnancy from 2 weeks before receiving study drug until 3 months after receiving the last dose of study drug. A highly effective method of contraception is defined as having a low failure rate (< 1% per year) when used consistently and correctly.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03079440

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Contact: Changhoon Yoo, MD +82-2-3010-1727

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Korea, Republic of
Asan Medical Center, University of Ulsan College of Medicine Recruiting
Seoul, Korea, Republic of, 05505
Contact: Changhoon Yoo, MD    +82-2-3010-1727   
Sponsors and Collaborators
Asan Medical Center
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Principal Investigator: Baek-Yeol Ryoo, MD Asan Medical Center

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Responsible Party: Baek-Yeol Ryoo, Professor, Asan Medical Center Identifier: NCT03079440    
Other Study ID Numbers: Asan-ONCHBP-2017-002
First Posted: March 14, 2017    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Baek-Yeol Ryoo, Asan Medical Center:
Neuroendocrine tumors
Neuroendocrine Carcinoma
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Carcinoma, Neuroendocrine
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents