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

Non-Small-Cell Lung Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01048645
• Other study ID #: ICC/302/07
• Status: Completed
• Phase: Phase 2
• First received: December 30, 2009
• Last updated: January 12, 2010
• Start date: September 2007
• Est. completion date: November 2009

Study information

• Verified date: January 2010
• Source: National Institute of Cancerología
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: National Council of Science and Technology
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: November 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small-Cell Lung Carcinoma

Intervention

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

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

Locations

Country	Name	City	State
Mexico	National Institute of Cancerología	Mexico City

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Cancerología	Instituto Nacional de Enfermedades Respiratorias

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Evaluate the efficiency and safety of low doses of ATRA in patients with advanced NSCLC who receive first-line CT.		2 years	Yes