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

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ClinicalTrials.gov Identifier: NCT00407758
Recruitment Status : Completed
First Posted : December 5, 2006
Results First Posted : November 21, 2017
Last Update Posted : November 21, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment Phase
Ovarian Cancer Primary Peritoneal Cavity Cancer Drug: enzastaurin hydrochloride Phase 2

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Evaluation of Enzastaurin (Lilly IND # 60, 933) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
Study Start Date : November 2006
Primary Completion Date : August 1, 2016


Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0 [ Time Frame: 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.

  2. Progression-free Survival > 6 Months Using RECIST 1.0 [ Time Frame: 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.

  3. Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0 [ Time Frame: 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 :
  1. Duration Overall Survival [ Time Frame: 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.

  2. Duration of Progression-free Survival (PFS) [ Time Frame: 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.

  3. Prognostic Factor - Number of Patients With Platinum Sensitivity [ Time Frame: Baseline ]
    Platinum sensitive = a platinum-free interval between 6 and 12 months.

  4. Prognostic Factor - Initial Performance Status [ Time Frame: 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

  5. Prognostic Factor - Age at Study Entry [ Time Frame: Baseline ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00407758


Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Evanston Northwestern Healthcare - Evanston Hospital
Evanston, Illinois, United States, 60201-1781
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, United States, 60521
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
St. Vincent Indianapolis Hospital
Indianapolis, Indiana, United States, 46260
United States, Michigan
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
United States, Missouri
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
United States, Nebraska
Methodist Estabrook Cancer Center
Omaha, Nebraska, United States, 68114
United States, North Carolina
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
United States, Oklahoma
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
United States, Washington
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Lydia Usha, MD Rush University Medical Center
OverallOfficial: Jean A. Hurteau, MD NorthShore University HealthSystem Research Institute
More Information

Publications:
Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00407758     History of Changes
Other Study ID Numbers: GOG-0170J
CDR0000517318
LILLY-H6Q-MC-S025
First Posted: December 5, 2006    Key Record Dates
Results First Posted: November 21, 2017
Last Update Posted: November 21, 2017
Last Verified: August 2017

Keywords provided by Gynecologic Oncology Group:
recurrent ovarian epithelial cancer
primary peritoneal cavity cancer

Additional relevant MeSH terms:
Peritoneal Neoplasms
Abdominal Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases