Comparing Two Treatments for Ovarian Cancer: Standard Chemotherapy Plus Enzastaurin, or Placebo ("Sugar Pill")
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00391118
First received: October 19, 2006
Last updated: July 19, 2012
Last verified: July 2012
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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:
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 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: enzastaurin
1125 mg loading dose then 500 mg, oral, daily, six 21 day cycles or up to 3 years
Other Name: LY317615
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
|
| Placebo Comparator: B |
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 | |
| 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. | |
| Berlin, Germany, 13353 | |
| 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. | |
| Duesseldorf, Germany, 40489 | |
| 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. | |
| Erlangen, Germany, D-91054 | |
| 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. | |
| Wiesbaden, Germany, D-65199 | |
| Poland | |
| 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. | |
| Gdansk, Poland, 80-402 | |
| 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. | |
| Warsaw, Poland, 02-781 | |
| Russian Federation | |
| 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. | |
| Ivanovo, Russian Federation, 153040 | |
| 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. | |
| Kazan, Russian Federation, 420029 | |
| 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. | |
| 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:
No publications provided
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00391118 History of Changes |
| Other Study ID Numbers: | 10708, H6Q-MC-S019 |
| Study First Received: | October 19, 2006 |
| Last Updated: | July 19, 2012 |
| 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 |
Additional relevant MeSH terms:
|
Neoplasms Fallopian Tube Neoplasms Ovarian Neoplasms Peritoneal Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Fallopian Tube Diseases Adnexal Diseases Genital Diseases, Female Endocrine Gland Neoplasms Ovarian Diseases Endocrine System Diseases Gonadal Disorders |
Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on June 17, 2013