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

NCT01048645 | Completed Phase 2 DMC

• 1 other identifier: ICC/302/07
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Small-Cell Lung Carcinoma

Keywords

All-trans retinoic acid; non-small cell lung cancer; retinoic acid receptor beta; chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  2 years

Study Arms (2)

P/PC arm

PLACEBO COMPARATOR

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

Other: PLACEBO

RA/PC arm

EXPERIMENTAL

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

Drug: ATRA

Interventions

ATRA DRUG

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

RA/PC arm

PLACEBO OTHER

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

P/PC arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Institute of Cancerología: lead
• Instituto Nacional de Enfermedades Respiratorias: collaborator

Study Sites (1)

National Institute of Cancerología

Mexico City, Mexico City, 14080, Mexico

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Oscar Arrieta, M.D.

  National Institute of Cancerología

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: December 30, 2009
• First Posted: January 13, 2010
• Study Start: September 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: November 1, 2009
• Last Updated: January 13, 2010

Record last verified: 2010-01

Locations

ME (1)