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OpenTrials
Completed

NCT Number: NCT00087711

A Randomized Phase 3 Trial of Pemetrexed and Cisplatin Versus Gemcitabine and Cisplatin in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer

This study is a randomized Phase 3 study comparing pemetrexed and cisplatin combination to gemcitabine and cisplatin for the treatment of Non Small Cell Lung Cancer (NCSLC). Gemcitabine plus cisplatin is currently the standard of care for NSCLC. It is thought that pemetrexed plus cisplatin may be as effective and may have fewer side effects than the standard of care.

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Key information

Conditions

Non Small Cell Lung Carcinoma 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 3

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Bahía Blanca, Argentina

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of NSCLC Stage IIIB not amenable to curative treatment or Stage IV.
  • No prior chemotherapy for lung cancer.
  • Patients must have at least one uni-dimensionally measurable lesion.
  • Prior radiation therapy to less than 25% of bone marrow, whole pelvis not allowed. Radiation must be completed at least 4 weeks prior to study enrollment.

Exclusion criteria

  • Treatment with any drug within the last 30 days that has not received regulatory approval.
  • Serious cardiac condition.
  • Serious medical disorder in addition to NSCLC that would make it difficult for the patient to complete the study.
  • Inability or unwillingness to take folic acid or Vitamin B12 supplementation.
  • Presence of fluid retention that cannot be controlled by drainage.

Treatment and study plan

Pemetrexed

Drug

500 mg/m2, IV q 21 days x 6 cycles

Other names: LY231514, Alimta

Gemcitabine

Drug

1250 mg/m2, IV, day 1 and 8 q 21 days x 6 cycles

Other names: LY188011, Gemzar

Cisplatin

Drug

75 mg/m2, IV, q 21 days x 6 cycles

Primary outcomes

  1. Overall survival

    Time frame: baseline to date of death from any cause

Secondary outcomes

  1. Progression free survival

    Time frame: baseline to measured progressive disease

  2. Time to progressive disease

    Time frame: baseline to measured progressive disease

  3. Duration of response

    Time frame: time of response to progressive disease

  4. Time to treatment failure

    Time frame: baseline to stopping treatment

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Randomized Phase 3 Trial of ALIMTA and Cisplatin Versus GEMZAR and Cisplatin in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Important dates

Study start
2004
Primary completion
2007
Study completion
2008
First posted
Jul 16, 2004
Registry last updated
Sep 12, 2019

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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