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

March 28, 2006
May 27, 2010
March 2006
July 2009   (final data collection date for primary outcome measure)
Time to progressive disease [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
To determine if the time to disease progression of the docetaxel plus carboplatin patients can be improved upon as compared to patients receiving pemetrexed plus carboplatin with or without enzastaurin
Complete list of historical versions of study NCT00308750 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Comparison of time to disease progression between all treatment groups
  • Assessment of biomarkers relevant to pemetrexed, carboplatin, enzastaurin, and disease state, and their correlation to clinical outcome
  • Assessment of smoking history and hormone replacement therapy and the correlation to clinical outcome
  • Comparisons of safety between each treatment arm
  • Comparisons of efficacy between each treatment arm
  • Comparisons of patient reported outcomes using the FACT-Lung and FACT-Taxane
Not Provided
Not Provided
 
First Line Chemotherapy Treatment of Advanced NSCLC
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)

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-small Cell Lung Cancer
  • 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: 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
  • Experimental: A
    Interventions:
    • Drug: enzastaurin
    • Drug: pemetrexed
    • Drug: carboplatin
  • Experimental: B
    Interventions:
    • Drug: pemetrexed
    • Drug: carboplatin
  • Active Comparator: C
    Interventions:
    • Drug: docetaxel
    • Drug: carboplatin
Socinski MA, Raju RN, Stinchcombe T, Kocs DM, Couch LS, Barrera D, Rousey SR, Choksi JK, Jotte R, Patt DA, Periman PO, Schlossberg HR, Weissman CH, Wang Y, Asmar L, Pritchard S, Bromund J, Peng G, Treat J, Obasaju CK. Randomized, phase II trial of pemetrexed and carboplatin with or without enzastaurin versus docetaxel and carboplatin as first-line treatment of patients with stage IIIB/IV non-small cell lung cancer. J Thorac Oncol. 2010 Dec;5(12):1963-9. doi: 10.1097/JTO.0b013e3181fd42eb.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
217
July 2009
July 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00308750
10651, H6Q-US-S004
No
Chief Medical Officer, Eli Lilly
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP