Study of Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin Versus Pemetrexed + Carboplatin + Bevacizumab + Placebo in Patients With Non-Small Cell Lung Cancer Who Have Not Been Previously Treated With Chemotherapy

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The purpose of this study is to determine if Pemetrexed plus Carboplatin plus Bevacizumab plus Enzastaurin, followed by maintenance Bevacizumab plus Enzastaurin can extend survival time without disease progression in the first-line treatment of patients with advanced stage non-small cell lung cancer.

Condition or disease	Intervention/treatment	Phase
Non-small Cell Lung Cancer	Drug: enzastaurin; Drug: pemetrexed; Drug: carboplatin; Drug: bevacizumab; Drug: Placebo	Phase 2

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	40 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	Protocol H6Q-MC-S034(a) Randomized, Double-Blind, Phase 2 Study of Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin Versus Pemetrexed + Carboplatin + Bevacizumab + Placebo in Chemonaive Patients With Stage IIIB or IV Non-Small Cell Lung Cancer
Study Start Date :	October 2007
Actual Primary Completion Date :	February 2009
Actual Study Completion Date :	February 2009

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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, day 8 of cycle 1 - 28 days, day 1 of subsequent cycles q 21 days x 3 cycles; Other Names: LY231514; Alimta Drug: carboplatin; AUC 6, IV day 8 cycle 1 - 28 days, day 1 of subsequent cycles q 21 days x 3 cycles Drug: bevacizumab; 15 mg/kg, IV, Day 8 of cycle 1 - 28 days, day 1 of subsequent cycles q 21 days x 3 cycles
Placebo Comparator: B	Drug: pemetrexed; 500 mg/m2, IV, day 8 of cycle 1 - 28 days, day 1 of subsequent cycles q 21 days x 3 cycles; Other Names: LY231514; Alimta Drug: carboplatin; AUC 6, IV day 8 cycle 1 - 28 days, day 1 of subsequent cycles q 21 days x 3 cycles Drug: bevacizumab; 15 mg/kg, IV, Day 8 of cycle 1 - 28 days, day 1 of subsequent cycles q 21 days x 3 cycles Drug: Placebo; oral, daily

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Progression-free survival [ Time Frame: baseline to measured progressive disease ]

Secondary Outcome Measures :

1. Response rate [ Time Frame: baseline to measured progressive disease ]
2. Overall survival [ Time Frame: baseline to date of death from any cause ]
3. Time to progressive disease [ Time Frame: baseline to measured progressive disease ]
4. Duration of response [ Time Frame: time of response to disease progression ]
5. Pharmacology toxicity [ Time Frame: every cycle ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• they or their legal representative must have signed an informed consent document for clinical research
• have laboratory confirmed diagnosis of advanced, nonsquamous cell NSCLC (Stage IIIB or IV disease) which is not curable
• have not received any prior systemic chemotherapy, immunotherapy, targeted therapy, or biological therapy for advanced NSCLC, prior radiation therapy is allowed to less than 25% of the bone marrow
• have measurable disease
• have adequate organ function and estimated life expectancy of 12 weeks

Exclusion Criteria:

• have known CNS disease; major surgery within 28 days; minor surgery within 7 days; serious concommitant systemic disorder; serious cardiac condition; have a serious, nonhealing wound, ulcer, or bone fracture
• have received treatment within the last 30 days with any drug that has not received regulatory approval for any indication at the time of study entry
• have previously received treatment with enzastaurin, pemetrexed, or bevacizumab
• are pregnant or breast-feeding
• are unable to swallow tablets

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Arkansas
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.
Bentonville, Arkansas, United States, 72712
United States, Illinois
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.
Chicago, Illinois, United States, 60611
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.
Galesburg, Illinois, United States, 61401
United States, Indiana
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.
Bloomington, Indiana, United States, 47403
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.
Evansville, Indiana, United States, 47714
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.
Fort Wayne, Indiana, United States, 46815
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.
Indianapolis, Indiana, United States, 46202
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.
Lafayette, Indiana, United States, 47904
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.
Muncie, Indiana, United States, 47303
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.
South Bend, Indiana, United States, 46601
United States, Michigan
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.
Jackson, Michigan, United States, 49201
United States, Nebraska
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.
Omaha, Nebraska, United States, 68114

Sponsors and Collaborators

Eli Lilly and Company

Genentech, Inc.

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Lilly Clinical Trial Registry 

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00533429 History of Changes
Other Study ID Numbers:	11398; H6Q-MC-S034
First Posted:	September 21, 2007
Last Update Posted:	February 18, 2010
Last Verified:	February 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; Bevacizumab; Carboplatin	Pemetrexed; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Growth Inhibitors; Antineoplastic Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors