Evaluation of Efficacy, Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic Non-small Cell Lung Cancer

Eisai

Status and phase: Completed; Phase 3

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: carboplatin and paclitaxel; Drug: bexarotene with carboplatin and paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00050960

L1069-48

Details and patient eligibility

About

This study evaluates the use of Targretin capsules (bexarotene) in combination with standard chemotherapy for the treatment of metastatic Non-Small Cell Lung Cancer (NSCLC) in patients who have not yet received chemotherapy for their lung cancer.

Full description

This study evaluates the use of Targretin capsules (bexarotene) in combination with Carboplatin and Paclitaxel for the treatment of metastatic non-small cell lung cancer in patients who have not yet received chemotherapy for their lung cancer. Every patient receives a platinum-containing chemotherapy every three weeks for at least four chemotherapy cycles (approximately four months). Half of the patients are randomly assigned to receive Targretin capsules once daily in addition to the chemotherapy. The other half is randomized to receive a standard platinum-containing chemotherapy without Targretin capsules.

Enrollment: 612 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Patients must have:

• Pathologic (histologic or cytologic) confirmation of NSCLC
• Stage IIIB with malignant pleural effusion or Stage IV disease
• At least one measurable or evaluable NSCLC lesion that has not been previously irradiated unless radiation therapy was more than three weeks prior to entry in the study and the lesion has been shown to have progressed subsequent to the radiation therapy
• ECOG performance status 0 or 1
• Adequate organ system function
• Fasting serum triglycerides that are within the age-adjusted normal range (or normalized with appropriate intervention such as antilipid therapy prior to the initiation of Targretin capsule therapy).

Patients must be able to complete at least four cycles of combination chemotherapy (i.e., approximately four months)

Patients must not have had:

• Brain metastasis
• Prior chemotherapy for NSCLC
• Prior platinum-based chemotherapy for any indication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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612 participants in 2 patient groups

bexarotene with carboplatin and paclitaxel

Experimental group

Treatment:

Drug: bexarotene with carboplatin and paclitaxel

carboplatin and paclitaxel

Experimental group

Treatment:

Drug: carboplatin and paclitaxel