AzTrials
AzTrials

Neuroendocrine CarcinomaPhase 2NCT03168594

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

A Phase 2 study testing irinotecan cisplatin and Etoposide cisplatin in people with Neuroendocrine Carcinoma, run by Peking University at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neuroendocrine Carcinoma
What is being tested?
irinotecan cisplatin and Etoposide cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteChina
Study dates
29 Apr 2017to 20 Sep 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • sign written informed consent form
  • age ≥ 18 years
  • pathologically confirmed poorly-differentiated neuroendocrine carcinoma, G3(Ki67>20%);
  • 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;
  • 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);
  • 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;
Show all 10Show fewer
  • KPS ≥ 70;
  • Predicted survival >=3 months;
  • Negative serum or urine pregnant test within 7 days prior to randomization for child-bearing age women;
  • Sexually active males or females willing to practice contraception during the study until 30 days after end of study.

Who cannot join

  • Hypersensitivity to IRI, DDP, VP-16,5-HT3 receptor antagonists;
  • 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;
  • Received surgery within past 4 weeks, or have not recovered from surgery;
  • Severe diarrhea;
  • Concurrent severe infection；
  • 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);
Show all 14Show fewer
  • Prior long term steroid therapy (excluding short term steroid treatment which is completed prior to > 2 weeks of study enrollment)；
  • Meningeal carcinomatosis;
  • Patients with central nervous system(CNS) disorder or peripheral nervous system disorder or psychiatric disease；
  • 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；
  • Pregnant or nursing, or sexually active males or females refuse to practice contraception during the study until 30 days after end of study;
  • 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；
  • Person with no capacity (legally) or inappropriate to continue study treatment for ethics/medical reasons；
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

Other trials in China

About this study

Official title: 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.

Being tested
irinotecan cisplatin, Etoposide cisplatin
Keywords
chemotherapy, OS, ORR, PFS, safety
Medical subject headings
Carcinoma, Neuroendocrine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • irinotecan cisplatinDrug

    Irinotecan：60mg/m2 ，iv drip for 90min，d1,8 q3W cisplatin: 60mg/m2 ，iv drip for 120min，d1 q3W

  • Etoposide cisplatinDrug

    Etoposide：100mg/m2 ，iv drip for 60min，d1-3 q3W cisplatin: 75mg/m2 ，iv drip for 120min，d1 q3W

Study groups in NCT03168594
Study groupRoleWhat they receive
A:Irinotecan combined with cisplatin (IP regimen)Experimentalpatients 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
Receives: Drug: irinotecan cisplatin
B:Etoposide combined with cisplatin (EP regimen)Experimentalpatients 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
Receives: Drug: Etoposide cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate (ORR)

    CT/MRI will be performed every 2 cycles of treatment by RECIST 1.1

    Measured: 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 outcomes (3)

  1. Progression-free survival

    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

    Measured: baseline, every 8 weeks up to 1 year after last patient first treatment

  2. Overall survival

    Overall survival is defined as the time from date of start of treatment to date of death due to any cause

    Measured: baseline, every 8 weeks up to 1 year after last patient first treatment

  3. Incidence of Treatment-Emergent Adverse Events （Safety and Tolerability）

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2017
  2. Study start29 Apr 2017
  3. Primary completion20 Feb 2019
  4. Study completion20 Sep 2019

Why it stopped: The enrollment was terminated early because the premature analysis found similar response in the two arms.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03168594
Sponsor's protocol ID
EP vs. IP
Status last verified
Jan 2020
First submitted
10 May 2017
Last updated
22 Jan 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing irinotecan cisplatin and Etoposide cisplatin in people with Neuroendocrine Carcinoma, run by Peking University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The enrollment was terminated early because the premature analysis found similar response in the two arms.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03168594.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020; AzTrials last refreshed its copy on 6 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in