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

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ClinicalTrials.gov Identifier: NCT03079440
Recruitment Status : Recruiting
First Posted : March 14, 2017
Last Update Posted : September 19, 2017
Sponsor:
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
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 : May 2019
Estimated Study Completion Date : October 2020


Arm Intervention/treatment
Experimental: TEMCAP
Temozolomide plus Capecitabine
Drug: TEMCAP
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



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

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 ClinicalTrials.gov identifier (NCT number): NCT03079440


Contacts
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Contact: Changhoon Yoo, MD +82-2-3010-1727 yooc@amc.seoul.kr

Locations
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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    yooc@amc.seoul.kr   
Sponsors and Collaborators
Asan Medical Center
Investigators
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Principal Investigator: Baek-Yeol Ryoo, MD Asan Medical Center

Publications:

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Responsible Party: Baek-Yeol Ryoo, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03079440     History of Changes
Other Study ID Numbers: Asan-ONCHBP-2017-002
First Posted: March 14, 2017    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017
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
Capecitabine
Temozolomide
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Carcinoma, Neuroendocrine
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Carcinoma
Adenocarcinoma
Capecitabine
Temozolomide
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents