Enzastaurin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer

Phase 2

Completed

Conditions: Ovarian Cancer
Primary Peritoneal Cavity Cancer

Registration Number: NCT00407758

Lead Sponsor: Gynecologic Oncology Group

Brief Summary: RATIONALE: Enzastaurin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well enzastaurin works in treating patients with persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer.

Detailed Description: OBJECTIVES:

Primary

* Assess the efficacy of enzastaurin hydrochloride, in terms of 6-month progression-free survival or objective tumor response, in patients with recurrent or persistent ovarian epithelial or primary peritoneal cancer.

* Determine the nature and degree of toxicity of this regimen in these patients.

Secondary

* Determine the duration of progression-free and overall survival of patients treated with this regimen.

* Determine the effects of prognostic variables, including platinum sensitivity, initial performance status, and age, in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral enzastaurin hydrochloride 3 times on day 1 and then once daily on days 2-28 of course 1. For all subsequent courses, patients receive enzastaurin hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 68 patients will be accrued for this study.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0	CT scan or MRI if used to follow lesions for measurable disease every other cycle for the first 6 months; every 6 months thereafter until disease progression for up to 5 years.	RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above.
Progression-free Survival > 6 Months Using RECIST 1.0	CT scan or MRI if used to follow lesion for measurable disease every other cycle for first 6 months; every 6 months thereafter until disease progression for up to 5 years.	Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0	Assessed every cycle while on treatment, 30 days after the last cycle of treatment	Number of participants with a maximum grade of 3 or higher during the treatment period.

Secondary Outcome Measures

Name	Time	Method
Duration Overall Survival	Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.	Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
Duration of Progression-free Survival (PFS)	CT scan or MRI if used to follow lesion for measurable disease every other cycle for first 6 months; every 6 months thereafter until disease progression for up to 5 years.	Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
Prognostic Factor - Number of Patients With Platinum Sensitivity	Baseline	Platinum sensitive = a platinum-free interval between 6 and 12 months.
Prognostic Factor - Initial Performance Status	Baseline	Performance status 0 = Fully active, able to carry on all pre-disease performance without restriction Performance status 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work
Prognostic Factor - Age at Study Entry	Baseline

Trial Locations

Locations (16): CCOP - Carle Cancer Center
🇺🇸
Urbana, Illinois, United States
Hulston Cancer Center at Cox Medical Center South
🇺🇸
Springfield, Missouri, United States
Rush University Medical Center
🇺🇸
Chicago, Illinois, United States
CCOP - Grand Rapids
🇺🇸
Grand Rapids, Michigan, United States
Blumenthal Cancer Center at Carolinas Medical Center
🇺🇸
Charlotte, North Carolina, United States
Jonsson Comprehensive Cancer Center at UCLA
🇺🇸
Los Angeles, California, United States
Evanston Northwestern Healthcare - Evanston Hospital
🇺🇸
Evanston, Illinois, United States
University Cancer Center at University of Washington Medical Center
🇺🇸
Seattle, Washington, United States
St. Vincent Indianapolis Hospital
🇺🇸
Indianapolis, Indiana, United States
Decatur Memorial Hospital Cancer Care Institute
🇺🇸
Decatur, Illinois, United States
Fox Chase Cancer Center - Philadelphia
🇺🇸
Philadelphia, Pennsylvania, United States
Hinsdale Hematology Oncology Associates
🇺🇸
Hinsdale, Illinois, United States
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
🇺🇸
Reading, Pennsylvania, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
🇺🇸
Abington, Pennsylvania, United States
Methodist Estabrook Cancer Center
🇺🇸
Omaha, Nebraska, United States
Oklahoma University Cancer Institute
🇺🇸
Oklahoma City, Oklahoma, United States