First Line Chemotherapy Treatment of Advanced NSCLC

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00308750
First received: March 28, 2006
Last updated: May 27, 2010
Last verified: May 2010
  Purpose

The purposes of this study are to determine:

The safety of enzastaurin plus pemetrexed with carboplatin, pemetrexed with carboplatin, or docetaxel with carboplatin and any side effects that might be associated with the combination of these drugs.

Whether the combination of enzastaurin plus pemetrexed and carboplatin or pemetrexed and carboplatin can help patients with non-small cell lung cancer live longer, compared with the combination of docetaxel and carboplatin.

Whether the combination of enzastaurin plus pemetrexed and carboplatin or pemetrexed and carboplatin can make your tumor smaller or disappear, and for how long, compared with the combination of docetaxel and carboplatin.

The effects of enzastaurin plus pemetrexed with carboplatin, pemetrexed with carboplatin or docetaxel with carboplatin have on your disease related symptoms.

The relation of smoking history and hormone replacement therapy (for women only) may have to your lung cancer treatment results.

The effects of certain genes and proteins in samples of your blood and tumor tissue in order to learn more about non-small cell lung cancer and how enzastaurin works in the body.


Condition Intervention Phase
Non-small Cell Lung Cancer
Drug: enzastaurin
Drug: pemetrexed
Drug: docetaxel
Drug: carboplatin
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 Randomized, Open-label Phase II Study of Pemetrexed (Alimta) Plus Carboplatin With or Without Enzastaurin Hydrochloride, or Docetaxel Plus Carboplatin as First Line Treatment in Patients With Advanced Stage Non-small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Time to progressive disease [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of biomarkers relevant to pemetrexed, carboplatin, enzastaurin, and disease state, and their correlation to clinical outcome [ Time Frame: baseline, cycle 1, cycle 2, end of study ] [ Designated as safety issue: No ]
  • Assessment of smoking history and hormone replacement therapy and the correlation to clinical outcome [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Comparisons of safety between each treatment arm [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
  • Comparisons of patient reported outcomes using the FACT-Lung and FACT-Taxane [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
  • Overall survival [ Time Frame: baseline to date of death from any cause ] [ Designated as safety issue: Yes ]
  • Duration of response [ Time Frame: time of response to progressive disease ] [ Designated as safety issue: No ]
  • Time to treatment failure [ Time Frame: baseline to stopping treatment ] [ Designated as safety issue: Yes ]

Enrollment: 217
Study Start Date: March 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: enzastaurin
1125-1200 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 or progressive disease
Other Names:
  • LY231514
  • Alimta
Drug: carboplatin
AUC 6, IV, q 21 days, six 21 day cycles or progressive disease
Experimental: B Drug: pemetrexed
500 mg/m2, IV, q 21 days, six 21 day cycles or progressive disease
Other Names:
  • LY231514
  • Alimta
Drug: carboplatin
AUC 6, IV, q 21 days, six 21 day cycles or progressive disease
Active Comparator: C Drug: docetaxel
75 mg/m2, IV, q 21 days, six 21 day cycles or progressive disease
Drug: carboplatin
AUC 6, IV, q 21 days, six 21 day cycles or progressive disease

  Eligibility

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

Inclusion Criteria:

  • You must have been diagnosed with non-small cell lung cancer.
  • You must be able to visit the doctor's office weekly during the active treatment period and as needed during the study follow-up period.
  • You must be willing and able to swallow capsules.
  • Your entry labs and medical tests must meet study requirements.
  • You must be willing to have blood samples drawn and tissue samples obtained for gene and protein testing.

Exclusion Criteria:

  • You have received radiation within 2 weeks of study enrollment.
  • You have previously received any anti-cancer drug therapy for non-small cell lung cancer.
  • You have an active infection or other serious condition.
  • You take aspirin or aspirin-like medication regularly and are not able to stop taking them for a few days during each cycle of chemotherapy.
  • You have recently lost a significant amount of weight.
  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: NCT00308750

Locations
United States, North Carolina
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.
Burlington, North Carolina, United States, 27215
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.
Chapel Hill, North Carolina, United States, 27599
United States, South Carolina
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.
Columbia, South Carolina, United States, 29210
United States, Texas
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.
Houston, Texas, United States, 77060
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00308750     History of Changes
Other Study ID Numbers: 10651, H6Q-US-S004
Study First Received: March 28, 2006
Last Updated: May 27, 2010
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
Docetaxel
Pemetrexed
Carboplatin
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 July 26, 2014