Study to Compare Irinotecan Combined With Cisplatin (IP) Versus Etoposide Combined With Cisplatin (EP) in Advanced and Metastatic Gastrointestinal Pancreatic and Esophageal Neuroendocrine Carcinoma

January 19, 2020 updated by: Shen Lin, Peking University

A Randomized, Controlled Phase II Study to Compare Irinotecan Combined With Cisplatin (IP) Versus Etoposide Combined With Cisplatin (EP) in Advanced and Metastatic Gastrointestinal Pancreatic and Esophageal Neuroendocrine Carcinoma

The study will be conducted to compare the safety and efficacy of irinotecan combined with cisplatin (IP regimen) and etoposide combined with cisplatin (EP regimen) in advanced or metastatic gastrointestinal pancreatic and esophageal neuroendocrine carcinoma.

In this prospective randomized phase II study, the investigators aim to compare the survival benefit as well as the safety for irinotecan combined with cisplatin (IP regimen) versus etoposide combined with cisplatin (EP regimen) in advanced or metastatic gastrointestinal pancreatic and esophageal neuroendocrine carcinoma.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

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, 100142
        • Beijing Cancer Hospital

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. sign written informed consent form
  2. age ≥ 18 years
  3. pathologically confirmed poorly-differentiated neuroendocrine carcinoma, G3(Ki67>20%);
  4. No prior antitumor treatment is allowed, including chemotherapy, radiotherapy, immune therapy or target therapy. For recurrent patients after radical surgery, adjuvant chemotherapy should not include irinotecan, cisplatin or etoposide, and the last date should beyond 6 months prior to randomization;
  5. At least 1 measurable lesion (only 1 measurable lymph node lesion is excluded) (routine CT scan >=20mm, spiral CT scan >=10mm, no prior radiation to measurable lesions);
  6. Screening laboratory values must meet the following criteria (within past 7 days): hemoglobin ≥ 9.0 g/dL; neutrophils ≥ 1500 cells/ μL; platelets ≥ 100 x 10^3/ μL; total bilirubin ≤ 1.5 x upper limit of normal (ULN); aspartic transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN without, and ≤ 5 x ULN with hepatic metastasis; serum creatinine ≤1╳ULN;
  7. KPS ≥ 70;
  8. Predicted survival >=3 months;
  9. Negative serum or urine pregnant test within 7 days prior to randomization for child-bearing age women;
  10. Sexually active males or females willing to practice contraception during the study until 30 days after end of study.

Exclusion Criteria:

  1. Hypersensitivity to IRI, DDP, VP-16,5-HT3 receptor antagonists;
  2. Prior antitumor therapy (including corticosteroids and immunotherapy) or participation in other clinical trials within past 4 weeks, or have not recovered from toxicities since the last treatment;
  3. Received surgery within past 4 weeks, or have not recovered from surgery;
  4. Severe diarrhea;
  5. Concurrent severe infection；
  6. Severe, uncontrolled medical condition that would affect patients' compliance or obscure the interpretation of toxicity determination or adverse events, including severe liver disease (active hepatitis, cirrhosis), uncontrolled diabetes or hypertension, or pulmonary disease ( interstitial pneumonia, obstructive pulmonary disease or symptomatic bronchospasm);
  7. Prior long term steroid therapy (excluding short term steroid treatment which is completed prior to > 2 weeks of study enrollment)；
  8. Meningeal carcinomatosis;
  9. Patients with central nervous system(CNS) disorder or peripheral nervous system disorder or psychiatric disease；
  10. Known history of uncontrolled or symptomatic angina, uncontrolled arrhythmias and hypertension, or congestive heart failure, or cardiac infarction within 6 months prior to study enrollment, or cardiac insufficiency；
  11. Pregnant or nursing, or sexually active males or females refuse to practice contraception during the study until 30 days after end of study;
  12. History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma, are eligible；
  13. Person with no capacity (legally) or inappropriate to continue study treatment for ethics/medical reasons；
  14. Underlying medical condition that, in the Investigator's opinion, would increase the risks of study drug administration or obscure the interpretation of toxicity determination or adverse events.

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: A:Irinotecan combined with cisplatin (IP regimen)
patients in arm A will receive chemotherapy of IP regimen: Irinotecan：60mg/m2 ，iv drip for 90min，d1,8 q3W cisplatin: 60mg/m2 ，iv drip for 120min，d1 q3W
Drug: irinotecan cisplatin
Irinotecan：60mg/m2 ，iv drip for 90min，d1,8 q3W cisplatin: 60mg/m2 ，iv drip for 120min，d1 q3W
EXPERIMENTAL: B:Etoposide combined with cisplatin (EP regimen)
patients in arm B will receive chemotherapy of EP regimen: Etoposide：100mg/m2 ，iv drip for 60min，d1-3 q3W cisplatin: 75mg/m2 ，iv drip for 120min，d1 q3W
Drug: Etoposide cisplatin
Etoposide：100mg/m2 ，iv drip for 60min，d1-3 q3W cisplatin: 75mg/m2 ，iv drip for 120min，d1 q3W

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR)
Time Frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
CT/MRI will be performed every 2 cycles of treatment by RECIST 1.1
From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: baseline, every 8 weeks up to 1 year after last patient first treatment
Progression-free survival is defined as the time from the date of first dose to the date of the first documented radiological progression or death due to any cause
baseline, every 8 weeks up to 1 year after last patient first treatment
Overall survival
Time Frame: baseline, every 8 weeks up to 1 year after last patient first treatment
Overall survival is defined as the time from date of start of treatment to date of death due to any cause
baseline, every 8 weeks up to 1 year after last patient first treatment
Incidence of Treatment-Emergent Adverse Events （Safety and Tolerability）
Time Frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Collaborators and Investigators

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

Sponsor

Peking University

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)

April 29, 2017

Primary Completion (ACTUAL)

February 20, 2019

Study Completion (ACTUAL)

September 20, 2019

Study Registration Dates

First Submitted

May 10, 2017

First Submitted That Met QC Criteria

May 24, 2017

First Posted (ACTUAL)

May 30, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 22, 2020

Last Update Submitted That Met QC Criteria

January 19, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EP vs. IP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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