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

NCT ID: NCT03168594

Last Updated: 2020-01-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-29
• Study Completion Date: 2019-09-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

irinotecan cisplatin

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

Etoposide cisplatin

Intervention Type: DRUG

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

Interventions

irinotecan cisplatin

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

Intervention Type: DRUG

Etoposide cisplatin

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Shen Lin

MD, Professor, Chief of Department of GI Oncology, Peking University Cancer Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

EP vs. IP

Identifier Type: -

Identifier Source: org_study_id