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Completed

NCT Number: NCT00350792

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

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

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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

70 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., Bobigny, France

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Pemetrexed

Drug

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

Other names: LY231514, Alimta

carboplatin

Drug

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

Primary outcomes

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

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

    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.

Secondary outcomes

  1. Time to Treatment Failure

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

    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.

  2. Overall Survival

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

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

  3. Estimated Probability of One Year Progression-free Survival

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

    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.

Other outcomes

  1. Time to Treatment Failure

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

    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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase II Trial Pemetrexed Carboplatin as First Line Chemotherapy for Advanced Non-Small Cell Lung Cancer (NSCLC) in Elderly Patients

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Jul 11, 2006
Registry last updated
Oct 13, 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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