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

This study has been terminated.
(Trial was stopped early due to low enrollment)
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00383331
First received: September 29, 2006
Last updated: May 28, 2009
Last verified: May 2009
  Purpose

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 Intervention Phase
Non-Small-Cell Lung Cancer
Drug: Pemetrexed
Drug: Gemcitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Best Overall Tumor Response [ Time Frame: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up ] [ Designated as safety issue: No ]
  • Time to Progressive Disease [ Time Frame: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up ] [ Designated as safety issue: No ]
  • Duration of Response [ Time Frame: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up ] [ Designated as safety issue: No ]
  • Time to Treatment Failure [ Time Frame: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up ] [ Designated as safety issue: Yes ]
  • Overall Survival [ Time Frame: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up ] [ Designated as safety issue: Yes ]

Enrollment: 19
Study Start Date: February 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00383331     History of Changes
Other Study ID Numbers: 9431, H3E-US-S061
Study First Received: September 29, 2006
Results First Received: January 6, 2009
Last Updated: May 28, 2009
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 20, 2014