Study to Evaluate the Efficiency of SOX as Seconde-line Chemotherapy in Neuroendocrine Carcinoma

Phase II Study of SOX as the Seconde Line Chemotherapy in Advanced or Metastatic Neuroendocrine Carcinoma

Currently, there is no standard second line treatment for patients with neuroendocrine carcinoma. SOX regimen has shown promising in previous study. The study was designed to confirm thet SOX regimen can be used as a second-line regimen for patients with advanced or metastatic neuroendocrine carcinoma who have progressed after first-line chemotherapy with platinum based regimen.

Study Overview

• Status: Unknown
• Conditions: Neuroendocrine Carcinoma
• Intervention / Treatment: Drug: SOX

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Beijing Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 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 with OXA, progress after first line chemotherapy with platinum-based regimen. For recurrent patients after radical surgery, platinum-based adjuvant chemotherapy 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 OXA,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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SOX; OXA：130mg/m2 ，iv drip for 180min d1, S-1 40-60mg p.o. bid d1-14, q3W	Drug: SOX; OXA：130mg/m2 ，iv drip for 180min d1, S-1 40-60mg p.o. bid d1-14, q3W

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rate (ORR)	CT/MRI will be performed every 2 cycles of treatment for efficacy evaluation 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	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	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-related Adverse Events （Safety and Tolerability）	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

• Sponsor: Peking University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: September 10, 2017
• First Submitted That Met QC Criteria: September 10, 2017
• First Posted (Actual): September 12, 2017

Study Record Updates

• Last Update Posted (Actual): September 12, 2017
• Last Update Submitted That Met QC Criteria: September 10, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: safety; ORR; PFS; OS
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Carcinoma; Carcinoma, Neuroendocrine
• Other Study ID Numbers: SOX-2

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