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

NCT ID: NCT00407758

Last Updated: 2019-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30

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.

Conditions

Ovarian Cancer; Primary Peritoneal Cavity Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

enzastaurin hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

PATIENT CHARACTERISTICS:

• GOG performance status 0-1 (for patients who received 2 prior treatment regimens) OR 0-2 (for patients who received 1 prior treatment regimen)
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9 g/dL (transfusions allowed)
• Creatinine < 1.5 times upper limit of normal (ULN)
• Bilirubin ≤ 2 times ULN
• Alkaline phosphatase ≤ 3 times ULN (5 times ULN if liver metastases are present)
• AST and ALT ≤ 3 times ULN (5 times ULN if liver metastases are present)
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after completion of study treatment
• Able to swallow tablets
• No sensory or motor neuropathy > grade 1
• No active infection requiring antibiotics
• No other invasive malignancies or evidence of cancer within the past 5 years except nonmelanoma skin cancer
• No serious systemic disorders that would preclude study compliance, including an abnormal ECG indicative of cardiac disease

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Recovered from prior surgery, radiotherapy, or chemotherapy
• At least 1 week since prior anticancer hormonal therapy
• No more than 1 additional cytotoxic regimen for management of recurrent or persistent disease
• At least 4 weeks since other prior anticancer therapy, including immunotherapy
• At least 30 days since prior investigational drugs
• No prior enzastaurin hydrochloride
• No prior radiotherapy to > 25% of marrow-bearing areas
• No prior noncytotoxic therapy, including bevacizumab, for recurrent or persistent disease
• No prior treatment that would preclude treatment on this protocol
• No concurrent chemotherapy, immunotherapy, or other experimental medications
• No concurrent enzyme-inducing antiepileptic drugs, including carbamazepine, phenobarbital, or phenytoin
• No other concurrent systemic anticancer therapy
• No concurrent radiotherapy, including palliative radiotherapy
• No concurrent agents that stimulate thrombopoiesis
• No concurrent amifostine or other protective reagents
• Concurrent hormone replacement therapy allowed
• Concurrent bisphosphonates allowed provided bony metastases are present

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Gynecologic Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lydia Usha, MD

Role: STUDY_CHAIR

Rush University Medical Center

Jean A. Hurteau, MD

Role: STUDY_CHAIR

Endeavor Health

Locations

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, United States

Rush University Medical Center

Chicago, Illinois, United States

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, United States

Evanston Northwestern Healthcare - Evanston Hospital

Evanston, Illinois, United States

Hinsdale Hematology Oncology Associates

Hinsdale, Illinois, United States

CCOP - Carle Cancer Center

Urbana, Illinois, United States

St. Vincent Indianapolis Hospital

Indianapolis, Indiana, United States

CCOP - Grand Rapids

Grand Rapids, Michigan, United States

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, United States

Methodist Estabrook Cancer Center

Omaha, Nebraska, United States

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, United States

Oklahoma University Cancer Institute

Oklahoma City, Oklahoma, United States

Rosenfeld Cancer Center at Abington Memorial Hospital

Abington, Pennsylvania, United States

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, United States

McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

Reading, Pennsylvania, United States

University Cancer Center at University of Washington Medical Center

Seattle, Washington, United States

Countries

United States

References

Usha L, Sill MW, Darcy KM, Benbrook DM, Hurteau JA, Michelin DP, Mannel RS, Hanjani P, De Geest K, Godwin AK. A Gynecologic Oncology Group phase II trial of the protein kinase C-beta inhibitor, enzastaurin and evaluation of markers with potential predictive and prognostic value in persistent or recurrent epithelial ovarian and primary peritoneal malignancies. Gynecol Oncol. 2011 Jun 1;121(3):455-61. doi: 10.1016/j.ygyno.2011.02.013. Epub 2011 Mar 17.

Reference Type: RESULT

PMID: 21414654 (View on PubMed)

Other Identifiers

CDR0000517318

Identifier Type: -

Identifier Source: secondary_id

LILLY-H6Q-MC-S025

Identifier Type: -

Identifier Source: secondary_id

GOG-0170J

Identifier Type: -

Identifier Source: org_study_id