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Evaluation of Enzastaurin in the Treatment of Persistent or Recurrent Ovarian or Primary Peritoneal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00420381
Recruitment Status : Completed
First Posted : January 11, 2007
Last Update Posted : March 30, 2015
Gynecologic Oncology Group
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The purpose is to assess the efficacy and toxicity of the study agent, enzastaurin, in patients with recurrent or persistent ovarian cancer.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Neoplasms Carcinoma Drug: enzastaurin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Evaluation of Enzastaurin in the Treatment of Persistent or Recurrent Ovarian or Primary Peritoneal Carcinoma
Study Start Date : January 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Experimental: A Drug: enzastaurin
1125 mg loading dose then 500 mg, oral, daily, until progressive disease
Other Name: LY317615

Primary Outcome Measures :
  1. Frequency of patients who survive progression-free for at least 6 months or have objective tumor response [ Time Frame: 6 months ]
  2. Frequency and severity of adverse effects [ Time Frame: every cycle ]

Secondary Outcome Measures :
  1. Duration of progression-free survival and overall survival [ Time Frame: baseline to measured progressive disease or date of death from any cause ]
  2. Prognostic factors such as platinum sensitivity, initial performance status, and age [ Time Frame: baseline ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients must have recurrent or persistent epithelial ovarian or primary peritoneal carcinoma.
  • All patients must have measurable disease.
  • Patients must have at least one "target lesion" to be used to assess response on this protocol.
  • Patients must not be eligible for a higher priority GOG protocol, if one exists.
  • Patients who have received one prior regimen must have a GOG Performance Status of 0, 1, or 2. Patients who have received two prior regimens must have a GOG Performance Status of 0 or 1.
  • Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration. Continuation of hormone replacement therapy is permitted.
  • Any other prior therapy directed at the malignant tumor, including immunologic agents, must be discontinued at least four weeks prior to registration.
  • Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound.
  • Patients must NOT have received any non-cytotoxic therapy for management of recurrent or persistent disease.
  • Patients of child-bearing potential must have a negative serum pregnancy test prior to study entry and be practicing an effective form of contraception (for example, intrauterine device [IUD], birth control pills, or barrier device) during and for 3 months after discontinuation of study treatment.

Exclusion Criteria:

  • Patients with previous enzastaurin treatment.
  • Patients who have received radiation to more than 25% of marrow-bearing areas
  • Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy.
  • Patients who have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
  • Patients who are unable to discontinue use of carbamazepine, phenobarbital, and phenytoin (refer to Concomitant Medications for a discussion of enzyme inducing anti-epileptic drugs [EIAEDs]).
  • Patients who are receiving concurrent administration of any other systemic anticancer therapy except for a biphosphonate if patient has bony metastases.
  • Patients who have received prior therapy with non-cytotoxic agents (i.e. bevacizumab).
  • Patients with serious concomitant systemic disorders (for example, active infection or abnormal electrocardiogram (ECG) indicative of cardiac disease) that, in the opinion of the investigator, would compromise the safety of the patient and his/her ability to complete the study.

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 identifier (NCT number): NCT00420381

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United States, Pennsylvania
Gynecologic Oncology Group 215-854-0770
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Eli Lilly and Company
Gynecologic Oncology Group
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Study Director: Lydia Usha Gynecologic Oncology Group

Additional Information:
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Responsible Party: Eli Lilly and Company Identifier: NCT00420381     History of Changes
Other Study ID Numbers: 10738
H6Q-MC-S025 ( Other Identifier: Eli Lilly and Company )
First Posted: January 11, 2007    Key Record Dates
Last Update Posted: March 30, 2015
Last Verified: March 2015
Keywords provided by Eli Lilly and Company:
Recurrent Cancer
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type