Pemetrexed/Carboplatin Non-Small Cell Lung Cancer (NSCLC) Elderly Patients

Lilly

Status and phase: Completed; Phase 2

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: carboplatin; Drug: pemetrexed

Study type: Interventional

Funder types: Industry

Identifiers

NCT00350792

9941

H3E-FP-S099 (Other Identifier)

Details and patient eligibility

About

A phase II study to evaluate the efficacy and safety profile of the combination of Pemetrexed and Carboplatin in elderly patients with advanced non-small cell lung cancer

Enrollment: 62 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pathologically confirmed Non Small Cell Lung Cancer Stage IIIb (not amenable to radiotherapy treatment) or Stage IV
• No previous chemotherapy for lung cancer
• Men and women > or = 70 years
• At least one uni-dimensionally measurable lesion (Response Evaluation Criteria In Solid Tumors [RECIST]criteria)
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1

Exclusion criteria

• Treatment within the last 30 days with a drug that has not received regulatory approval
• Serious systemic disorders
• Inability to discontinue administration of aspirin or anti-inflammatory non steroid
• Concurrent administration of any other antitumor therapy
• Brain metastasis

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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62 participants in 1 patient group

Pemetrexed + Carboplatin

Experimental group

Description:

Pemetrexed: 500 milligrams per square meter (mg/m\^2), intravenous (IV), every 21 days x 6 cycles. Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles.

Treatment:

Drug: carboplatin

Drug: pemetrexed