Chemotherapy With Pemetrexed in Combination With Platinum for Advanced Non-Small Cell Lung Cancer (NSCLC)

Phase 2CompletedNCT00402051

Eli Lilly and Company133 enrolled

Overview

This is a two-arm, parallel, open-label, Phase 2 multicenter study of pemetrexed as first line combination therapy with either cisplatin or carboplatin in the palliative setting of stage IIIb and IV non-small cell lung cancer patients. Approximately 130 patients will be included in about 15 centers in Germany and randomized to one of the above treatment regimens in a 1:1 ratio. Chemotherapy will be administered over a maximum of six cycles with a standard length of 21 days. Primary objective will be the Progression Free Survival Time of patients as assessed in both treatment arms.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

133

Conditions

Non-Small-Cell Lung Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Cytologically and/or histologically confirmed NSCLC Stage IIIb or IV * No previous systemic chemotherapy for this cancer * At least one uni-dimensionally measurable lesion meeting Response Evaluation Criteria In Solid Tumors (RECIST) criteria * Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1 and adequate organ function * Prior radiation therapy allowed but limited to \<25% of the patient's bone marrow Exclusion Criteria: * Serious concomitant systemic disorder or active infection * Mild to moderate renal insufficiency, but unable to interrupt salicylates or other nonsteroidal anti-inflammatory drugs * Symptomatic central nervous system (CNS) metastases requiring concurrent corticosteroid therapy * Presence of clinically significant third-space fluid collections

Locations (12)

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.

Coswig, Germany

Frankfurt, Germany

Großhansdorf, Germany

Halle, Germany

Outcomes

Primary Outcomes

Percentage of Participants Surviving Progression-Free at 6 Months (Progression Free Survival [PFS] Rate)

For this study, we used the exponential distribution (assumption done for the calculation of the sample size) to estimate the PFS rate. The PFS rate (%) and the 95% confidence intervals were calculated based on the following formula: exp(-6 λ) ± 1.96 \* exp(-6 λ) \* (-6 λ)/√r. Where λ was calculated based on the Maximum-Likelihood estimator for ln(λ) as given by (Collett 2003): ln(λ) = ln\[ r / ∑ti \] with r = number of patients with events up to 6 months, ti = survival time of patient i (i=1,…,n), event or censored up to 6 months, and n= total number of patients per treatment group.

Time frame: Randomization to Month 6

Secondary Outcomes

Overall Survival

Defined as the time from randomization to the date of death from any cause.

Time frame: Randomization to date of death from any cause (up to 1 year)

Number of Participants With Tumor Response (as Basis for Response Rate)

Best overall response was evaluated using RECIST Criteria which define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatment. CR: complete response, disappearance of all target lesions; PR: partial response, 30% decrease in sum of the longest diameter of target lesions; PD: progressive disease, 20% increase in sum of the longest diameter of target lesions; SD: stable disease, small changes not meeting above criteria. Response Rate: number of participants with response(CR+PR)per total population, multiplied by 100 to give a percentage.

Time frame: Every 6 weeks for 6 months during the treatment period, and every 3 months during the follow-up period, until disease progression

Time to Treatment Failure (TTF)

Defined as time from randomization to the first date of disease progression, death due to any cause, or early discontinuation of treatment (any reason), whichever occurred first

Time frame: Randomization to stopping of treatment, progression, death or initiation of further chemotherapy, whichever occurs first (up to 1 year)

Pharmacology Toxicities

Number of patients experiencing Grade 3 or 4 hematologic and non-hematologic adverse events (AEs) possibly related to study drug or protocol procedures in this study (a subset of those listed in the AE Module). AEs were graded using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) for defining and grading specific adverse events. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death). Grade 3 AEs are severe and undesirable; Grade 4 AEs are life-threatening or disabling.

Time frame: Every 21-day cycle for up to 6 cycles

Hamburg, Germany

Hofheim, Germany

Homburg/Saar, Germany

Immenhausen, Germany

Leipzig, Germany

Lübeck, Germany