Etoposide/Cisplatin Compared With Irinotecan/Cisplatin for Advanced Gastrointestinal Neuroendocrine Tumor G3 Type

NCT03963193 | Unknown Phase 2

• 1 other identifier: HNCH-GI-005
• Study Type: interventional
• Target: 112
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to investigate the efficacy, safety, and survival benefit of etoposide plus cisplatin and irinotecan plus cisplatin in first-line therapy of non-primary pancreatic metastatic and/or unresectable gastrointestinal neuroendocrine tumor G3 type. In addition, the investigators will explore the resistance mechanisms of gastrointestinal neuroendocrine tumor G3, and screen out biomarkers that can predict the efficacy of chemotherapy.

Conditions

Gastrointestinal Neuroendocrine Tumor

Outcome Measures

Primary Outcomes (2)

• Objective response rate (ORR)

  To compare objective response rate of the two arms from date of anti-cancer therapy until progression

  up to 2 years

• Progression-free Survival (PFS)

  From the first day of treatment until the date of first documented progression or date of death from any cause

  up to 2 years

Secondary Outcomes (3)

• Overall survival (OS)

  up to 2 years

• Number of Participants with Treatment-related Adverse Events

  up to 2 years

• Assessment of Health-related quality of life

  up to 2 years

Study Arms (2)

Etoposide plus Cisplatin

EXPERIMENTAL

Etoposide 100mg/m\^2 ivggt on days 1, 2, 3, Cisplatin 25mg/m\^2 ivggt on days 1, 2, 3, repeated every 21 days. When the investigator believes that the participant is not suitable for continued medication or the evaluation is progressive disease (PD) according to the RECIST 1.1 standard, the medication is over.

Drug: Etoposide

Irinotecan plus Cisplatin

EXPERIMENTAL

Irinotecan 65 mg/m\^2 ivggt on days 1, 8, Cisplatin 30 mg/m\^2 ivggt on days 1, 8, repeated every 21 days. When the investigator believes that the participant is not suitable for continued medication or the evaluation is progressive disease (PD) according to the RECIST 1.1 standard, the medication is over.

Drug: Irinotecan

Interventions

Etoposide DRUG

Etoposide 100mg/m\^2 ivggt on days 1, 2, 3, Cisplatin 25mg/m\^2 ivggt on days 1, 2, 3, repeated every 21 days.

Also known as: Cisplatin

Etoposide plus Cisplatin

Irinotecan DRUG

Irinotecan 65 mg/m\^2 ivggt on days 1, 8, Cisplatin 30 mg/m\^2 ivggt on days 1, 8, repeated every 21 days.

Also known as: Cisplatin

Irinotecan plus Cisplatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 18-75 years old, male or female. 2. Confirmed non-primary pancreatic metastatic and/or unresectable gastrointestinal neuroendocrine tumor G3 type patients by histopathological and imaging examinations.
• \. ECOG performance status 0-1. 4. Life expectancy ≥ 12 weeks. 5. A histological specimen can be provided for secondary testing. 6. According to the evaluation criteria of solid tumor efficacy (RESIST 1.1), there should be at least one measurable lesion (empty organs such as esophagus and stomach cannot be taken as the measurable lesion), and the measurable lesion should not have received local treatment such as radiotherapy (the lesion located in the previous radiotherapy area is also selected as the target lesion if the lesion progression is confirmed).
• \. Never received system treatment before, including cytotoxic drugs. For patients who have received adjuvant or neoadjuvant chemotherapy appears recurrence or metastasis more than 6 months from accepting the last dose of chemotherapy drugs can be screened.
• \. The main organ function meets the following criteria within 7 days before treatment:
• Blood routine examination criteria (without blood transfusion within 14 days): hemoglobin (HB) ≥ 90g/L, the absolute value of neutrophils (ANC) ≥ 1.5 x 10\^9/L, platelet (PLT) ≥ 80 x 10\^9/L.
• Biochemical examinations must meet the following criteria: total bilirubin (TBIL) ≤ 1.5 x upper limit of normal (ULN), alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 2.5 x ULN, serum creatinine (Cr) ≤ 1.5 x ULN or creatinine clearance (CCR) ≥ 60 mL/min.
• Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ normal low limit (50%).
• \. Fertile men and women must use effective contraception during the study period and within 6 months after the end of the study.
• \. Volunteered to participate in the study and signed an informed consent form.

You may not qualify if:

• Patients exceeding or currently suffering from other malignant tumors within 5 years, except for cervical cancer in site, non-melanoma skin cancer and superficial bladder tumors (Ta (non-invasive tumor), Tis (in situ carcinoma), and T1 (tumor infiltrating basement membrane)); Patients with rapid progress within 3 months.
• \. History of gastrointestinal perforation and/or fistula within 6 months prior to the first administration.
• \. Patients who had received radiotherapy for tumor target lesions within 4 weeks before enrollment.
• \. History of immunodeficiency disease, including HIV positive and other acquired or congenital immunodeficiency diseases.
• \. Allergic reactions and drug adverse reactions:
• A history of allergy to the ingredients of the study drug;
• Any contraindication to any study drug (etoposide, irinotecan and cis-platinum) in the chemotherapy regimen.
• \. Any severe and/or uncontrolled disease, including:
• Patients with hypertension whose blood can't be well controlled by antihypertensive drugs (systolic blood pressure ≥ 150 mmHg, diastolic blood pressure ≥ 100 mmHg).
• Grade 1 or higher myocardial ischemia or myocardial infarction, arrhythmia (including QTc ≥ 480 ms) or grade 2 and above congestive heart failure according to New York Heart Association (MYHA) classification.
• Severe or uncontrolled disease or active infection (≥ CTC AE grade 2), which the investigators believe may increase the risk associated with patient participation and drug administration.
• Renal failure requiring hemodialysis or peritoneal dialysis.
• Patients of diabetes who have poor glycemic control (fasting blood glucose (FBG) \> 10 mmol/L).
• Patients of seizures requiring treatment. 8. Patients with gastrointestinal disease such as intestinal obstruction (including incomplete intestinal obstruction) or those who may meet gastrointestinal bleeding, perforation obstruction.
• \. Patients who underwent surgical treatment, incision biopsy or significant traumatic injury within 28 days prior to enrollment.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

MeSH Terms

Conditions

Gastro-enteropancreatic neuroendocrine tumor

Interventions

Etoposide; Cisplatin; Irinotecan

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Baoxia He

  Henan Cancer Hospital

  STUDY DIRECTOR

Central Study Contacts

Ying Liu

CONTACT

13783604602; yaya7207@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: May 24, 2019
• Study Start: June 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2021
• Last Updated: May 24, 2019

Record last verified: 2019-05