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

NCT00407758 | Completed Phase 2 Results

• 3 other identifiers: GOG-0170JCDR0000517318LILLY-H6Q-MC-S025
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 16

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.

Conditions

Ovarian Cancer; Primary Peritoneal Cavity Cancer

Keywords

recurrent ovarian epithelial cancer; primary peritoneal cavity cancer

Outcome Measures

Primary Outcomes (3)

• Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0

  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.

  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.

• Progression-free Survival > 6 Months Using RECIST 1.0

  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.

  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.

• Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0

  Number of participants with a maximum grade of 3 or higher during the treatment period.

  Assessed every cycle while on treatment, 30 days after the last cycle of treatment

Secondary Outcomes (5)

• 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.

• 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.

• Prognostic Factor - Number of Patients With Platinum Sensitivity

  Baseline

• Prognostic Factor - Initial Performance Status

  Baseline

• Prognostic Factor - Age at Study Entry

  Baseline

Interventions

enzastaurin hydrochloride DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed ovarian epithelial or primary peritoneal carcinoma * Recurrent or persistent disease * Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan * Must have ≥ 1 target lesion to assess response * Tumors within a previously irradiated field are designated as "nontarget" lesions unless progression is documented or a biopsy is obtained to confirm persistence ≥ 90 days after completion of radiotherapy * Must have received 1 prior platinum-based chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound for management of primary disease * Initial treatment may have included high-dose therapy, consolidation therapy, or extended therapy administered after surgical or nonsurgical assessment * Must meet any 1 of the following criteria for platinum-based therapy: * Disease progression during therapy * Treatment-free interval after completion of treatment \< 12 months * Disease persistence after completion of therapy * Ineligible for a higher priority GOG clinical trial 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Gynecologic Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (16)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, 62526, United States

Location

Evanston Northwestern Healthcare - Evanston Hospital

Evanston, Illinois, 60201-1781, United States

Location

Hinsdale Hematology Oncology Associates

Hinsdale, Illinois, 60521, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

St. Vincent Indianapolis Hospital

Indianapolis, Indiana, 46260, United States

Location

CCOP - Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, 65807, United States

Location

Methodist Estabrook Cancer Center

Omaha, Nebraska, 68114, United States

Location

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, 28232-2861, United States

Location

Oklahoma University Cancer Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Rosenfeld Cancer Center at Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

Location

McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

Reading, Pennsylvania, 19612-6052, United States

Location

University Cancer Center at University of Washington Medical Center

Seattle, Washington, 98195-6043, United States

Location

Related Publications (1)

• 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.

  PMID: 21414654 RESULT

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Results Point of Contact

• Title: Angela Kuras on behalf of Mike Sill, PhD
• Organization: NRG Oncology

kurasa@nrgoncology.org

716-845-5702

Study Officials

• Lydia Usha, MD

  Rush University Medical Center

  STUDY CHAIR

• Jean A. Hurteau, MD

  Endeavor Health

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2006
• First Posted: December 5, 2006
• Study Start: November 1, 2006
• Primary Completion: August 1, 2016
• Last Updated: March 20, 2019
• Results First Posted: November 21, 2017

Record last verified: 2019-03

Locations

US (16)