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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

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ClinicalTrials.gov Identifier: NCT00533429
Recruitment Status : Completed
First Posted : September 21, 2007
Last Update Posted : February 18, 2010
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by:
Eli Lilly and Company

Study Description
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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
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00533429


Locations
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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
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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
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Additional Information:

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Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00533429    
Other Study ID Numbers: 11398
H6Q-MC-S034
First Posted: September 21, 2007    Key Record Dates
Last Update Posted: February 18, 2010
Last Verified: February 2010
Additional relevant MeSH terms:
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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
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors