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Dosage Schedule Study of Pemetrexed Monochemotherapy for Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

This study has been completed.
Information provided by:
Eli Lilly and Company Identifier:
First received: August 29, 2006
Last updated: October 15, 2009
Last verified: October 2009
Patients affected by non-small cell lung cancer (NSCLC) will be treated in pemetrexed monochemotherapy regimen for a maximum of 8 cycles. Pemetrexed is an enhancer of some biomolecules involved in the gemcitabine mechanism of action. Purpose of the trial is to monitor the blood values of these biomolecules at different time intervals, to optimize the synergism between pemetrexed and gemcitabine.

Condition Intervention Phase
Non Small Cell Lung Cancer
Drug: Pemetrexed - Before Protocol Amendment
Drug: Pemetrexed - After Protocol Amendment
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pemetrexed Monochemotherapy in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer. A Pilot Study to Define the Best Dosing Schedule for a Planned Phase II Randomized Trial

Resource links provided by NLM:

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Mean Deoxycytidine Kinase (dCK) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 [ Time Frame: pre-dose, 1, 2, 4, 6, 24, and 48 hours post-dose (3 cycles) ]
  • Mean Human Equilibrative Nucleoside Transporter 1 (hENT) Expression Evaluated at Cycle 1, Cycle 2, and Cycle 3 [ Time Frame: pre-dose, 1, 2, 4, 6, 24, and 48 hours post-dose (3 cycles) ]

Secondary Outcome Measures:
  • Best Objective Tumor Response [ Time Frame: baseline to measured response (every 14 days for 6 cycles) ]

Enrollment: 19
Study Start Date: September 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pemetrexed - Before Protocol Amendment Drug: Pemetrexed - Before Protocol Amendment
500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles or disease progression, unacceptable toxicity or patient decision to discontinue
Other Names:
  • LY231514
  • Alimta
Experimental: Pemetrexed - After Protocol Amendment Drug: Pemetrexed - After Protocol Amendment
500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 6 cycles or disease progression, unacceptable toxicity or patient decision to discontinue.
Other Names:
  • LY231514
  • Alimta


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

Inclusion Criteria

  • Histologically or cytologically proven IIIB and IV NSCLC.
  • No symptomatic uncontrolled brain metastasis
  • Not suitable for platinum containing regimens if chemo-naive
  • Performance status less than or equal to 2 on the Eastern Cooperative Oncology Group (ECOG) Scale.
  • Creatinine Clearance (CrCl) greater than or equal to 45 milliliters per min (mL/min)

Exclusion Criteria

  • Prior radiation to greater than 25% of bone marrow
  • Inability to interrupt Aspirin at doses of greater than 1.3 grams/day or non-steroidal anti-inflammatory agents for a 5-day period.
  • Presence of clinically relevant third-space fluid collections not controllable.
  • Significant cardiac disease
  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 identifier: NCT00370292

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.
Milano, Italy
Sponsors and Collaborators
Eli Lilly and Company
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:
Responsible Party: Chief Medical Officer, Eli Lilly Identifier: NCT00370292     History of Changes
Other Study ID Numbers: 10940
Study First Received: August 29, 2006
Results First Received: September 9, 2009
Last Updated: October 15, 2009

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors processed this record on May 22, 2017