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

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Cancerología
• Collaborator: Instituto Nacional de Enfermedades Respiratorias
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Paclitaxel; Tretinoin

Criteria

Inclusion Criteria:

• 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)

• Life expectancy of >12 weeks.

Exclusion Criteria:

• Patients who had received prior chemotherapy

• Patients with other comorbid conditions