Study for Patients With Advanced, Not Amenable to Surgery, or Metastatic Lung Cancer Comparing Treatment With Pemetrexed + Cisplatin + Enzastaurin Versus Pemetrexed + Cisplatin + Placebo

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00538681
First received: October 1, 2007
Last updated: October 16, 2009
Last verified: October 2009
  Purpose

This study is intended for patients with advanced, not amenable to surgery, or metastatic lung cancer who have not received any prior chemotherapy. The study will be conducted in 2 parts:

  • Part 1 is intended to evaluate safety of pemetrexed + cisplatin + enzastaurin combination chemotherapy
  • Part 2 whose main objective is to compare the efficacy of pemetrexed + cisplatin + enzastaurin versus pemetrexed + cisplatin + placebo. Patients to be included in Part 2 are those with Nonsquamous NSCLC.

Condition Intervention Phase
Lung Cancer
Drug: enzastaurin
Drug: pemetrexed
Drug: cisplatin
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo Controlled, Phase 2 Study of Pemetrexed and Cisplatin Plus Enzastaurin Versus Pemetrexed and Cisplatin Plus Placebo in Chemonaive Patients With Advanced, Unresectable, or Metastatic (Stage IIIB or IV) Nonsquamous Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Part 1: evaluate safety (toxicity, serious adverse events and reasons for patient discontinuation) [ Time Frame: each cycle ] [ Designated as safety issue: Yes ]
  • Part 2: compare progression-free survival between the 2 arms through the assessment of tumor response [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Part 2: to evaluate the safety and toxicity profile of study treatments [ Time Frame: each cycle ] [ Designated as safety issue: Yes ]
  • Part 2: response rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Part 2: overall survival [ Time Frame: baseline to date of death from any cause ] [ Designated as safety issue: Yes ]
  • Part 2: duration of disease control and response [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Part 2: time to worsening of symptoms [ Time Frame: each cycle ] [ Designated as safety issue: No ]
  • Part 2: to assess biomarkers of the disease state and their correlation to clinical outcome [ Time Frame: baseline, every other cycle, end of study ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: September 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: enzastaurin
1125 mg loading dose then 500 mg, oral, daily, until disease progression
Other Name: LY317615
Drug: pemetrexed
500 mg/m2, IV, q 21 days, six 21 day cycles
Other Names:
  • LY231514
  • Alimta
Drug: cisplatin
75 mg/m2, IV, q 21 days, six 21 day cycles
Placebo Comparator: B Drug: pemetrexed
500 mg/m2, IV, q 21 days, six 21 day cycles
Other Names:
  • LY231514
  • Alimta
Drug: cisplatin
75 mg/m2, IV, q 21 days, six 21 day cycles
Drug: placebo
oral, daily

  Eligibility

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

Inclusion Criteria:

  • diagnosis of advanced non-small cell lung cancer (NSCLC) not amenable to curative treatment. Patients enrolling in Part 2 of the study must have the above stated diagnosis of NSCLC that is also of nonsquamous histology.
  • no prior systemic therapies (chemotherapy, etc.)or pleurodesis with chemotherapy for this disease
  • prior radiotherapy is allowed but must be completed at least 2 weeks before study enrollment and patient must be recovered from the acute toxic effects
  • have a good performance status
  • patient must sign an informed consent document

Exclusion Criteria:

  • patient had myocardial infarction occurring less than 6 months before inclusion, uncontrolled arrhythmia, symptomatic angina pectoris, or cardiac failure not controlled by medications
  • patient is unable to swallow tablets
  • patient is taking a certain medicine to control seizure activity, called "enzyme inducing antiepileptic drugs" and is not able to stop taking the medicine prior to enrolling in the study
  • patient is unable to interrupt aspirin and/or other anti-inflammatory agents
  • patient is unwilling or unable to take vitamin supplementation (folic acid and vitamin B12) or medications to prevent side effects
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00538681

Locations
Belgium
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.
Leuven, Belgium, 3000
Germany
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.
Gauting, Germany, 82131
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.
GroBhansdorf, Germany, D-22927
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.
Hamburg, Germany, D 21075
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.
Heidelberg, Germany, 69126
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.
Bergamo, Italy, 24128
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.
Catania, Italy, 95100
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.
Padova, Italy, 35128
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.
Trento, Italy, 38100
Poland
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.
Otwock, Poland, 05-400
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.
Poznan, Poland, 60-569
Romania
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.
Bucharest, Romania, 022328
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 (UCT/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: NCT00538681     History of Changes
Other Study ID Numbers: 10722, H6Q-MC-S021
Study First Received: October 1, 2007
Last Updated: October 16, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pemetrexed
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on April 22, 2014