Comparing Two Treatments for Ovarian Cancer: Standard Chemotherapy Plus Enzastaurin, or Placebo ("Sugar Pill") - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00391118

Purpose

Patients with ovarian cancer usually get the drugs carboplatin and paclitaxel as initial treatment. In many patients the tumor will shrink, or even disappear, after treatment with these drugs. But, unfortunately, the tumor will grow again in many patients. This trial will try to address the question: Can we delay the time, till the tumor grows again, by adding a 3rd drug to the standard therapy? To answer this question, patients will, by chance, either get the experimental drug enzastaurin or a "dummy pill" (placebo) during the chemotherapy and for up to 3 years after chemotherapy.

Patients and physicians will not know, if a patient gets enzastaurin or placebo (double-blinded trial). After a predefined time, the treatment will be uncovered, and the number of patients with tumor growth at a specific time point will be compared between the two treatments.

Condition	Intervention	Phase
Ovarian Cancer Fallopian Tube Neoplasms Peritoneal Neoplasm	Drug: enzastaurin Drug: carboplatin Drug: paclitaxel Drug: placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Phase 2, Placebo-Controlled, Double-Blinded Study With and Without Enzastaurin in Combination With Paclitaxel and Carboplatin as First-Line Treatment, Followed by Maintenance Treatment in Advanced Ovarian Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Paclitaxel Carboplatin Enzastaurin

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Progression free survival [ Time Frame: baseline to progressive disease evaluated at 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression Free Survival [ Time Frame: baseline to measured progressive disease evaluated at 2 and 3 years ] [ Designated as safety issue: No ]
To compare the safety of the two treatments [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
To assess if biological markers in the tumors can be identified, which could enable to predict, who could profit from treatment with enzastaurin [ Time Frame: baseline, cycle 2, end of study ] [ Designated as safety issue: No ]
Pharmacokinetics [ Time Frame: cycle 1, cycle 2 ] [ Designated as safety issue: No ]

Estimated Enrollment:	149
Study Start Date:	November 2006
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: enzastaurin 1125 mg loading dose then 500 mg, oral, daily, six 21 day cycles or up to 3 years Drug: carboplatin AUC 5, IV, q 21 days, six 21 day cycles Drug: paclitaxel 175 mg/m2, IV, q 21 days, six 21 day cycles
B: Placebo Comparator	Drug: carboplatin AUC 5, IV, q 21 days, six 21 day cycles Drug: paclitaxel 175 mg/m2, IV, q 21 days, six 21 day cycles Drug: placebo oral, daily

Eligibility

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

Criteria

Inclusion Criteria:

Patients must have specific stages of disease, known as FIGO stages IIB, IIC, III or IV
Organ functions (blood, renal, liver, cardiac) must meet specific requirements.
Patients, who could become pregnant, must take care not to become pregnant during the study participation and for 6 months after study discontinuation
Patients must give written consent for study participation.

Exclusion Criteria:

Patients received any experimental drug within the last 30 days.
Patients received any prior chemotherapy or other drug therapy for the current disease.
Patients receive any other treatment for the cancer during study participation.
Patients are unable to discontinue concurrent administration of carbamazepine, phenobarbital, or phenytoin.
Patients are pregnant, breast feeding, or not using adequate contraceptive methods to prevent pregnancy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391118

Locations

Belgium
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.
Leuven, Belgium, 3000
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.
Liege, Belgium, 4000
Germany
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Berlin, Germany, 13353
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Duesseldorf, Germany, 40489
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Erlangen, Germany, D-91054
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Wiesbaden, Germany, D-65199
Poland
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Gdansk, Poland, 80-402
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Warsaw, Poland, 02-781
Russian Federation
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Ivanovo, Russian Federation, 153040
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Kazan, Russian Federation, 420029
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Moscow, Russian Federation, 115478
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.
Stavropol, Russian Federation, 355047
Spain
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.
Barcelona, Spain, 08035
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.
Madrid, Spain, 28041
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.
Valencia, Spain, 46010

Sponsors and Collaborators

Eli Lilly and Company

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

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	10708, H6Q-MC-S019
Study First Received:	October 19, 2006
Last Updated:	February 25, 2009
ClinicalTrials.gov Identifier:	NCT00391118 History of Changes
Health Authority:	United States: Food and Drug Administration; Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment; Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Fallopian Tube Cancer
Digestive System Neoplasms
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Antimitotic Agents
Carboplatin
Ovarian Diseases
Abdominal Neoplasms
Fallopian Tube Neoplasms

Fallopian Tube Diseases
Genital Diseases, Female
Digestive System Diseases
Paclitaxel
Tubulin Modulators
Peritoneal Diseases
Ovarian Cancer
Gastrointestinal Neoplasms
Endocrinopathy
Peritoneal Neoplasms
Antineoplastic Agents, Phytogenic
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Gonadal Disorders
Antineoplastic Agents
Urogenital Neoplasms
Ovarian Diseases
Genital Diseases, Female
Neoplasms by Site
Therapeutic Uses
Peritoneal Diseases
Endocrine Gland Neoplasms
Ovarian Neoplasms
Digestive System Neoplasms
Mitosis Modulators
Genital Neoplasms, Female

Endocrine System Diseases
Carboplatin
Antimitotic Agents
Abdominal Neoplasms
Fallopian Tube Neoplasms
Pharmacologic Actions
Adnexal Diseases
Fallopian Tube Diseases
Neoplasms
Digestive System Diseases
Paclitaxel
Tubulin Modulators
Peritoneal Neoplasms
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 06, 2009