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Pemetrexed and Gemcitabine Every 14 Days Versus Every 21 Days in Advanced Non Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00383331
Recruitment Status : Terminated (Trial was stopped early due to low enrollment)
First Posted : October 3, 2006
Results First Posted : May 14, 2009
Last Update Posted : June 3, 2009
Sponsor:
Information provided by:
Eli Lilly and Company

Study Description
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Brief Summary:
This study is designed to evaluate Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8 every 21 days (Arm A) and Pemetrexed and Gemcitabine Day 1 every 14 days (Arm B) in patients with NSCLC. Each agent and sequence has well demonstrated antitumor activity respectively in patients with locally advanced or metastatic NSCLC. Therefore, it is reasonable to investigate the most optimal schedule for this combination, and which combination is associated with the most anti-tumor activity in the phase II arena.

Condition or disease Intervention/treatment Phase
Non-Small-Cell Lung Cancer Drug: Pemetrexed Drug: Gemcitabine Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of ALIMTA® (Pemetrexed) and GEMZAR® (Gemcitabine) Every 14 Days Versus Pemetrexed and Gemcitabine Every 21 Days in Advanced Non-Small Cell Lung Cancer
Study Start Date : February 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: A Drug: Pemetrexed

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

B: 500 mg/m2, intravenous (IV), every 14 days x 9 cycles

Other Names:
  • LY231514
  • Alimta

Drug: Gemcitabine

A: 1250 mg/m2, intravenous (IV) days 1 and 8, every 21 days x 6 cycles

B: 1500 mg/m2, intravenous (IV), every 14 days x 9 cycles

Other Names:
  • LY188011
  • Gemzar
Experimental: B Drug: Pemetrexed

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

B: 500 mg/m2, intravenous (IV), every 14 days x 9 cycles

Other Names:
  • LY231514
  • Alimta

Drug: Gemcitabine

A: 1250 mg/m2, intravenous (IV) days 1 and 8, every 21 days x 6 cycles

B: 1500 mg/m2, intravenous (IV), every 14 days x 9 cycles

Other Names:
  • LY188011
  • Gemzar


Outcome Measures
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Primary Outcome Measures :
  1. Best Overall Tumor Response [ Time Frame: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up ]

Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up ]
  2. Time to Progressive Disease [ Time Frame: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up ]
  3. Duration of Response [ Time Frame: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up ]
  4. Time to Treatment Failure [ Time Frame: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up ]
  5. Overall Survival [ Time Frame: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histologic or cytologic diagnosis of NSCLC Stage IIIB or IV
  • no prior systemic chemotherapy for advanced Non-Small Cell Lung Cancer
  • Prior radiotherapy must be completed at least 4 weeks before study enrollment.

Exclusion Criteria:

  • estimated life expectancy of 12 weeks
  • a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease
  • documented brain metastases unless the patient has completed successful local therapy for central nervous system metastases and has been off of corticosteroids for at least 2 weeks before enrollment
  • significant weight loss (that is, > 10%) over the previous 6 weeks before study entry.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00383331


Locations
United States, Minnesota
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.
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
More Information
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Additional Information:
Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00383331     History of Changes
Other Study ID Numbers: 9431
H3E-US-S061
First Posted: October 3, 2006    Key Record Dates
Results First Posted: May 14, 2009
Last Update Posted: June 3, 2009
Last Verified: May 2009

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
Pemetrexed
 Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors