First Line Chemotherapy Treatment of Advanced NSCLC - Full Text View

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 Intervention Model: Parallel Assignment Masking: None (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:

Genetics Home Reference related topics: lung cancer

MedlinePlus related topics: Lung Cancer

Drug Information available for: Pemetrexed Pemetrexed disodium

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Time to progressive disease [ Time Frame: baseline to measured progressive disease ]

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 ]
Assessment of smoking history and hormone replacement therapy and the correlation to clinical outcome [ Time Frame: baseline ]
Comparisons of safety between each treatment arm [ Time Frame: every cycle ]
Comparisons of patient reported outcomes using the FACT-Lung and FACT-Taxane [ Time Frame: every cycle ]
Overall survival [ Time Frame: baseline to date of death from any cause ]
Duration of response [ Time Frame: time of response to progressive disease ]
Time to treatment failure [ Time Frame: baseline to stopping treatment ]


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 (Adult, Senior)
Sexes Eligible for Study:	All
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00308750 History of Changes
Other Study ID Numbers:	10651 H6Q-US-S004 ( Other Identifier: Eli Lilly and Company )
Study First Received:	March 28, 2006
Last Updated:	May 27, 2010

Additional relevant MeSH terms:


Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Docetaxel	Carboplatin Pemetrexed Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 19, 2017