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

This study has been completed.
Sponsor:
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

October 19, 2006
July 19, 2012
November 2006
April 2010   (final data collection date for primary outcome measure)
Progression free survival [ Time Frame: baseline to progressive disease evaluated at 18 months ] [ Designated as safety issue: No ]
To measure and to compare, in how many patients in the two treatment groups the tumor grows again at 18 months, after the patients have been assigned to one of the two treatment groups.
Complete list of historical versions of study NCT00391118 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Compare other efficacy measures between the 2 treatments, like tumor shrinkage in patients, or average time till the tumor grows again, during and after the treatment period
  • To compare the safety of the two treatments during the treatment phase
  • To assess, after the treatment period, if biological markers in the tumors can be identified, which could enable to predict, who could profit from treatment with enzastaurin
  • To measure potential interactions between the chemotherapeutic drugs and enzastaurin
  • Measure enzastaurin concentration in the blood, while taking the drug
Not Provided
Not Provided
 
Comparing Two Treatments for Ovarian Cancer: Standard Chemotherapy Plus Enzastaurin, or Placebo ("Sugar Pill")
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Ovarian Cancer
  • Fallopian Tube Neoplasms
  • Peritoneal Neoplasm
  • 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
  • Drug: placebo
    oral, daily
  • Experimental: A
    Interventions:
    • Drug: enzastaurin
    • Drug: carboplatin
    • Drug: paclitaxel
  • Placebo Comparator: B
    Interventions:
    • Drug: carboplatin
    • Drug: paclitaxel
    • Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
149
July 2012
April 2010   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Germany,   Poland,   Russian Federation,   Spain
 
NCT00391118
10708, H6Q-MC-S019
Yes
Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP