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

Phase 2TerminatedNCT00356525

Eli Lilly and Company41 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lung Neoplasms

Interventions

pemetrexedDRUG

500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression

gemcitabineDRUG

1500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression

carboplatinDRUG

area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (17)

Outcomes

Primary Outcomes

Objective Tumor Response

Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.

Time frame: baseline to time of response (up to 17.5 months)

Secondary Outcomes

Overall Survival

Overall survival is the number of participants who were alive when the trial was terminated.

Time frame: baseline to trial termination (17.5 months)

Time to Progressive Disease

Time frame: baseline to measured progressive disease (up to 17.5 months)

Duration of Response

Time frame: time of response to progressive disease (up to 17.5 months)

Time to Treatment Failure

Time frame: baseline to stopping treatment (up to 17.5 months)

Data from ClinicalTrials.gov

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Miami, Florida, United States

Evanston, Illinois, United States

Wichita, Kansas, United States

Minneapolis, Minnesota, United States

St Louis, Missouri, United States

Omaha, Nebraska, United States

Chapel Hill, North Carolina, United States

Chattanooga, Tennessee, United States

Memphis, Tennessee, United States

Nashville, Tennessee, United States

...and 7 more locations