Clareo Health | Effect of All-trans Retinoic Acid With Chemotherapy Based in Paclitaxel and Cisplatin as First Line Treatment of Patients With Advanced Non-small Cell Lung Cancer
Effect of All-trans Retinoic Acid With Chemotherapy Based in Paclitaxel and Cisplatin as First Line Treatment of Patients With Advanced Non-small Cell Lung Cancer
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Keep this study
Lead
National Institute of Cancerología
With
Instituto Nacional de Enfermedades Respiratorias
Purpose:
This randomized phase II trial evaluated whether the combination of cisplatin and paclitaxel plus All-trans retinoic acid (ATRA) increases Response rate (RR) and Progression-free survival (PFS) in patients with advanced Non-small cell lung cancer (NSCLC) with an acceptable toxicity profile and its association with the expression of Retinoic acid receptor beta 2 (RAR-beta2 ) as a response biomarker.
Patients and Methods:
Patients with stage IIIB and IV NSCLC were included to receive Paclitaxel and Cisplatin (PC). Patients were randomized to receive ATRA 20 mg/m2/day (RA/PC) or placebo (P/PC) 1 week prior to treatment until completing two cycles. RAR-beta2 expression was analyzed by Immunohistochemistry (IHC) and RT-PCR in tumor and adjacent lung tissue.
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Stage III B and IV NSCLC
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
No prior cytotoxic chemotherapy for NSCLC
Age ≥18 years, adequate laboratory measurements
Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
