Overview

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

Status:
Terminated
Trial end date:
2019-09-20
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Peking University
Treatments:
Camptothecin
Cisplatin
Etoposide
Etoposide phosphate
Irinotecan
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.