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

National Institute of Cancerología

Status and phase: Completed; Phase 2

Conditions: Non-Small-Cell Lung Carcinoma

Treatments: Other: PLACEBO; Drug: ATRA

Study type: Interventional

Funder types: Other

Identifiers

NCT01048645

ICC/302/07

Details and patient eligibility

About

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.

Full 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.

Enrollment: 107 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Exclusion criteria

• Patients who had received prior chemotherapy
• Patients with other comorbid conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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107 participants in 2 patient groups, including a placebo group

P/PC arm

Placebo Comparator group

Description:

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

Treatment:

Other: PLACEBO

RA/PC arm

Experimental group

Description:

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

Treatment:

Drug: ATRA