Clinical trial NCT01048645: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small-Cell Lung Carcinoma
Keywords: All-trans retinoic acid
non-small cell lung cancer
retinoic acid receptor beta
chemotherapy
Lead sponsor: National Institute of Cancerología
Sponsor class: OTHER_GOV
Collaborators: name: Instituto Nacional de Enfermedades Respiratorias
First posted: 2010-01-13
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 2 years
Secondary outcomes:
measure: Evaluate the efficiency and safety of low doses of ATRA in patients with advanced NSCLC who receive first-line CT.
timeFrame: 2 years
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: National Institute of Cancerología
Study officials:
affiliation: National Institute of Cancerología
name: Oscar Arrieta, M.D.
role: PRINCIPAL_INVESTIGATOR
References: