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

Sponsor

National Institute of Cancerología (Other)

Overall Status

Completed

CT.gov ID

NCT01048645

Collaborator

Instituto Nacional de Enfermedades Respiratorias (Other)

107

Enrollment

Location

Arms

Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Small-Cell Lung Carcinoma	Drug: ATRA Other: PLACEBO	Phase 2

Detailed Description

Purpose:

Patients and Methods:

Study Design

Study Type:

Interventional

Actual Enrollment :

107 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Randomized Phase II Trial: 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

Study Start Date :

Sep 1, 2007

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: P/PC arm Patients were assigned to receive placebo (P/PC) 1 week prior to treatment until completing two cycles	Other: PLACEBO Patients were randomized to receive or placebo (P/PC) 1 week prior to treatment until completing two courses of chemotherapy based on paclitaxel and cisplatin
Experimental: RA/PC arm Patients were assigned to receive ATRA 20 mg/m2/day (RA/PC) 1 week prior to treatment until completing two cycles	Drug: ATRA Patients were assigned to receive ATRA 20 mg/m2/day (RA/PC) 1 week prior to treatment until completing two courses of chemotherapy based on paclitaxel and cisplatin

Arm

Intervention/Treatment

Placebo Comparator: P/PC arm

Patients were assigned to receive placebo (P/PC) 1 week prior to treatment until completing two cycles

Other: PLACEBO

Patients were randomized to receive or placebo (P/PC) 1 week prior to treatment until completing two courses of chemotherapy based on paclitaxel and cisplatin

Experimental: RA/PC arm

Patients were assigned to receive ATRA 20 mg/m2/day (RA/PC) 1 week prior to treatment until completing two cycles

Drug: ATRA

Patients were assigned to receive ATRA 20 mg/m2/day (RA/PC) 1 week prior to treatment until completing two courses of chemotherapy based on paclitaxel and cisplatin

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.