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

NCT03168594 | Terminated Phase 2 DMC

• 1 other identifier: EP vs. IP
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Neuroendocrine Carcinoma

Keywords

chemotherapy; OS; ORR; PFS; safety

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  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 Outcomes (3)

• Progression-free survival

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

• Overall survival

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

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

  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

Study Arms (2)

A:Irinotecan combined with cisplatin (IP regimen)

EXPERIMENTAL

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

B:Etoposide combined with cisplatin (EP regimen)

EXPERIMENTAL

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

Interventions

irinotecan cisplatin DRUG

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

A:Irinotecan combined with cisplatin (IP regimen)

Etoposide cisplatin DRUG

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

B:Etoposide combined with cisplatin (EP regimen)

Eligibility Criteria

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

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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);
• 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.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Conditions

Carcinoma, Neuroendocrine

Interventions

PE regimen

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Professor, Chief of Department of GI Oncology, Peking University Cancer Hospital

Study Record Dates

• First Submitted: May 10, 2017
• First Posted: May 30, 2017
• Study Start: April 29, 2017
• Primary Completion: February 20, 2019
• Study Completion: September 20, 2019
• Last Updated: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)