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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Gynecologic Oncology Group
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00420381
First received: January 8, 2007
Last updated: June 27, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Ovarian Cancer
Neoplasms
Carcinoma
Drug: enzastaurin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Frequency of patients who survive progression-free for at least 6 months or have objective tumor response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Frequency and severity of adverse effects [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Duration of progression-free survival and overall survival [ Time Frame: baseline to measured progressive disease or date of death from any cause ] [ Designated as safety issue: No ]
  • Prognostic factors such as platinum sensitivity, initial performance status, and age [ Time Frame: baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2007
Estimated Study Completion Date: January 2015
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: enzastaurin
1125 mg loading dose then 500 mg, oral, daily, until progressive disease
Other Name: LY317615

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00420381

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

Additional Information:
No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00420381     History of Changes
Other Study ID Numbers: 10738, H6Q-MC-S025
Study First Received: January 8, 2007
Last Updated: June 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Recurrent Cancer

Additional relevant MeSH terms:
Carcinoma
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on September 18, 2014