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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00370292
First received: August 29, 2006
Last updated: October 15, 2009
Last verified: October 2009
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Best Objective Tumor Response [ Time Frame: baseline to measured response (every 14 days for 6 cycles) ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00370292

Locations
Italy
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
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: NCT00370292     History of Changes
Other Study ID Numbers: 10940, H3E-IT-S105
Study First Received: August 29, 2006
Results First Received: September 9, 2009
Last Updated: October 15, 2009
Health Authority: Italy: Ministry of Health

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
Pemetrexed
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on April 16, 2014