Chemotherapy Treatment in Re-occurring Non Small Cell Lung Cancer (NSCLC) After Previous Chemotherapy and Surgical Removal of the NSCLC Tumor

Lilly

Status and phase: Terminated; Phase 2

Conditions: Lung Neoplasms

Treatments: Drug: pemetrexed; Drug: carboplatin; Drug: gemcitabine; Drug: Pemetrexed

Study type: Interventional

Funder types: Industry

Identifiers

NCT00356525

H3E-US-S082 (Other Identifier)

9934

Details and patient eligibility

About

The purpose of this study is to help answer:

• Whether pemetrexed, gemcitabine and/or carboplatin can shrink tumor(s) or make tumor(s) disappear in patients with relapsed lung cancer (lung cancer that has come back after surgical removal and chemotherapy), and to determine how long this will last
• Whether pemetrexed, gemcitabine and/or carboplatin can help patients with relapsed lung cancer live longer

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• You have non-small cell lung cancer that has come back (relapsed) after initial treatment with surgery and chemotherapy.
• You have good kidney, liver, and bone marrow organ function.
• You are fully active or able to carry out light work such as housework or office work.

Exclusion criteria

• You have received pemetrexed or gemcitabine in the past for lung cancer
• You are currently receiving another treatment for your relapsed lung cancer, or have had chemotherapy or certain other therapies for relapsed lung cancer in the past
• You are unable to take corticosteroid drugs like dexamethasone
• You are unable or unwilling to take the folic acid pills or Vitamin B12 injections that are required for the study
• You are unable to stop taking aspirin or other drugs that control inflammation for certain periods of time during the study
• You have had a heart attack in the last 6 months, or have other heart problems that are not controlled with medication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 4 patient groups

Less Than One Year: Pemetrexed

Experimental group

Description:

Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy

Treatment:

Drug: gemcitabine

Drug: pemetrexed

Less Than One Year: Pemetrexed + Gemcitabine

Experimental group

Description:

Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy

Treatment:

Drug: Pemetrexed

One Year or Greater: Pemetrexed + Carboplatin

Experimental group

Description:

Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy

Treatment:

Drug: Pemetrexed

Drug: carboplatin

One Year or Greater: Pemetrexed + Gemcitabine

Experimental group

Description:

Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy

Treatment:

Drug: gemcitabine

Drug: pemetrexed