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

Phase 2

Completed

• Conditions: Non-Small-Cell Lung Carcinoma
• Interventions: Other: PLACEBO; Drug: ATRA

• Registration Number: NCT01048645
• Lead Sponsor: National Institute of Cancerología

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2007-09
• Primary Completion: 2008-12
• Study Completion: 2009-11
• Study First Submitted: 2009-12-30
• Status Verified: 2010-01
• Study First Submitted QC: 2010-01-12
• Last Update Submitted: 2010-01-12
• Study First Posted: 2010-01-13
• Last Update Posted: 2010-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
P/PC arm	PLACEBO	Patients were assigned to receive placebo (P/PC) 1 week prior to treatment until completing two cycles
RA/PC arm	ATRA	Patients were assigned to receive ATRA 20 mg/m2/day (RA/PC) 1 week prior to treatment until completing two cycles

Primary Outcome Measures

Name	Time	Method
The primary end-point was Response rate (RR) and Progression-free survival (PFS), as well as identifying whether expression of RAR-beta2 is a response biomarker.	2 years

Secondary Outcome Measures

Name	Time	Method
Evaluate the efficiency and safety of low doses of ATRA in patients with advanced NSCLC who receive first-line CT.	2 years

Trial Locations

Locations (1)

National Institute of Cancerología; 🇲🇽 Mexico City, Mexico