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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


Phase 2
18 Years
80 Years
Not Enrolling
Both
Non-Small-Cell Lung Carcinoma

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Trial Information

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


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.


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 ‚Č•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

Type of Study:

Interventional

Study Design:

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

Outcome 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.

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Oscar Arrieta, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Institute of Cancerología

Authority:

Mexico: National Council of Science and Technology

Study ID:

ICC/302/07

NCT ID:

NCT01048645

Start Date:

September 2007

Completion Date:

November 2009

Related Keywords:

  • Non-Small-Cell Lung Carcinoma
  • All-trans retinoic acid
  • non-small cell lung cancer
  • retinoic acid receptor beta
  • chemotherapy
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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