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NCT Number: NCT00402051

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

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.

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Key information

Conditions

Non-Small-Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pemetrexed

Drug

500 mg/m2, intravenous (IV), every 21 days x 6 cycles

Other names: LY231514, Alimta

Cisplatin

Drug

75 mg/m2, intravenous (IV), every 21 days x 6 cycles

carboplatin

Drug

Area under the concentration curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles

Primary outcomes

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

    Time frame: Randomization to Month 6

    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.

Secondary outcomes

  1. Overall Survival

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

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

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

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

    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.

  3. Time to Treatment Failure (TTF)

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

    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

  4. Pharmacology Toxicities

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

    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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Randomized Phase 2 Study of Pemetrexed in Combination With Cisplatin or Carboplatin in the First Line Therapy of Advanced NSCLC

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Nov 22, 2006
Registry last updated
Feb 17, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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