NCT03279614UnknownPhase 2
Phase II Study of SOX as the Seconde Line Chemotherapy in Advanced or Metastatic Neuroendocrine Carcinoma
Peking University1 site in 1 country45 target enrollmentStarted: September 1, 2017Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Overall response rate (ORR)
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •sign written informed consent form
- •age ≥ 18 years
- •pathologically confirmed poorly-differentiated neuroendocrine carcinoma, G3(Ki67>20%);
- •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;
- •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;
- •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.
Exclusion Criteria
- •Hypersensitivity to OXA,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.
Arms & Interventions
SOX
Experimental
OXA：130mg/m2 ，iv drip for 180min d1, S-1 40-60mg p.o. bid d1-14, q3W
Intervention: SOX (Drug)
Outcomes
Primary Outcomes
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
CT/MRI will be performed every 2 cycles of treatment for efficacy evaluation by RECIST 1.1
Secondary Outcomes
- 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-related 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)
Investigators
Shen Lin
MD, Professor, Chief of Department of GI Oncology, Peking University Cancer Hospital
Peking University
Study Sites (1)
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