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

Eli Lilly and Company62 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non Small Cell Lung Cancer

Interventions

pemetrexedDRUG

500 milligrams per square meter (mg/m\^2), intravenous (IV), every 21 days x 6 cycles

carboplatinDRUG

Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles

Eligibility

Sex: ALLMin age: 70 Years

Medical Language ↔ Plain English

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

Locations (7)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Bobigny, France

Outcomes

Primary Outcomes

Percentage of Participants With a Complete or Partial Tumor Response (Overall Tumor Response)

Tumor response is defined as the percentage of patients with either a complete response or a partial response. Response was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions and Partial Response=30% decrease in sum of longest diameter of target lesions.

Time frame: baseline to measured objective tumor response (up to six 21-day cycles)

Secondary Outcomes

Time to Treatment Failure

Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment. Time to treatment failure was censored at the date of the last follow-up visit for patients who did not discontinue early, who were still alive, and who have not progressed.

Time frame: baseline to stopping treatment (up to six 21-day cycles)

Overall Survival

Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.

Time frame: baseline to date of death from any cause (up to 14.5 months)

Estimated Probability of One Year Progression-free Survival

Progression free survival (PFS) is the duration from enrollment until first disease progression or death. For patients not known to have died as of the data cut-off date and who do not have progressive disease, PFS is censored at the last radiological assessment date.

Time frame: baseline to measured progressive disease or death, 1 year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.