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

• ClinicalTrials.gov Identifier: NCT00383331
• Recruitment Status: Terminated
• First Posted: October 3, 2006
• Results First Posted: May 14, 2009
• Last Update Posted: June 3, 2009
• Sponsor: Eli Lilly and Company
• Information provided by: Eli Lilly and Company

Study Description

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

• 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

Arms and Interventions

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

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 ]
   Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.

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 ]
   baseline to measured progressive disease
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 ]
   Time to progressive disease not analyzed because trial was stopped early due to low enrollment.
3. Duration of Response [ Time Frame: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up ]
   Duration of response was not analyzed because the trial was stopped early due to low enrollment.
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 ]
   Time to treatment failure was not analyzed because the trial was stopped early due to low enrollment.
5. Overall Survival [ Time Frame: baseline and every 14 or 21 day cycle (6-9 cycles), every 6 weeks post-therapy follow-up ]
   Survival time is defined as the time from date of randomization to death due to any cause.

Eligibility Criteria

• 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

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:

Lilly Clinical Trial Registry 

• Responsible Party: Chief Medical Officer, Eli Lilly
• ClinicalTrials.gov Identifier: NCT00383331
• Other Study ID Numbers: 9431; H3E-US-S061
• First Posted: October 3, 2006
• 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