Study to Evaluate the Efficiency of FOLFIRI as Seconde-line Chemotherapy in Neuroendocrine Carcinoma (NCT03168607) | Clinical Trial Compass
UnknownPhase 2
Study to Evaluate the Efficiency of FOLFIRI as Seconde-line Chemotherapy in Neuroendocrine Carcinoma
China45 participantsStarted 2017-05-02
Plain-language summary
Currently, there is no standard second line treatment for patients with neuroendocrine carcinoma. Irinotecan monotherapy or combination regimen has shown promising in previous study. The study was designed to confirm thet FOLFIRI 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. No prior antitumor treatment with irinotecan, 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;
✓. KPS ≥ 70;
✓. Predicted survival \>=3 months;
Exclusion criteria
✕. Hypersensitivity to IRI,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;
What they're measuring
1
Overall response rate (ORR)
Timeframe: 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
✕. 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)；