Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00407758
Recruitment Status : Completed
First Posted : December 5, 2006
Results First Posted : November 21, 2017
Last Update Posted : March 20, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
GOG Foundation ( Gynecologic Oncology Group )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Ovarian Cancer
Primary Peritoneal Cavity Cancer
Intervention Drug: enzastaurin hydrochloride
Enrollment 28
Recruitment Details This trial was opened to patient entry on November 6, 2006 and was closed to accrual on May 7, 2007.
Pre-assignment Details  
Arm/Group Title Enzastaurin
Hide Arm/Group Description Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
Period Title: Overall Study
Started 28
Completed [1] 27
Not Completed 1
Reason Not Completed
ineligible -improper prior treatment             1
[1]
Eligible and treated patients.
Arm/Group Title Enzastaurin
Hide Arm/Group Description Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
Overall Number of Baseline Participants 27
Hide Baseline Analysis Population Description
Eligible and treated patients
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
40-49 years
4
  14.8%
50-59 years
10
  37.0%
60-69 years
6
  22.2%
70-79 years
7
  25.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Female
27
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   3.7%
White
26
  96.3%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Number of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.0
Hide Description 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.
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.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients
Arm/Group Title Enzastaurin
Hide Arm/Group Description:
Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
Overall Number of Participants Analyzed 27
Measure Type: Count of Participants
Unit of Measure: Participants
Partial response 2
Complete response 0
2.Primary Outcome
Title Progression-free Survival > 6 Months Using RECIST 1.0
Hide Description 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.
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.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients
Arm/Group Title Enzastaurin
Hide Arm/Group Description:
Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
Overall Number of Participants Analyzed 27
Measure Type: Count of Participants
Unit of Measure: Participants
PFS> 6 months - Yes 3
PFS>6months - No 24
3.Primary Outcome
Title Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Hide Description Number of participants with a maximum grade of 3 or higher during the treatment period.
Time Frame Assessed every cycle while on treatment, 30 days after the last cycle of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients
Arm/Group Title Enzastaurin
Hide Arm/Group Description:
Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
Overall Number of Participants Analyzed 27
Measure Type: Count of Participants
Unit of Measure: Participants
Anemia 1
Constitutional 5
Gastrointestinal 11
Infection 2
Metabolic 4
Other Neurological 1
Pain 5
Pulmonary 5
Vascular 1
Death, not CTC coded 3
4.Secondary Outcome
Title Duration Overall Survival
Hide Description Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
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.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients
Arm/Group Title Enzastaurin
Hide Arm/Group Description:
Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
Overall Number of Participants Analyzed 27
Median (90% Confidence Interval)
Unit of Measure: months
15.1 [1] 
(6.5 to NA)
[1]
Upper limit not yet reached
5.Secondary Outcome
Title Duration of Progression-free Survival (PFS)
Hide Description 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.
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.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients
Arm/Group Title Enzastaurin
Hide Arm/Group Description:
Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
Overall Number of Participants Analyzed 27
Median (90% Confidence Interval)
Unit of Measure: months
1.8
(1.5 to 2.7)
6.Secondary Outcome
Title Prognostic Factor - Number of Patients With Platinum Sensitivity
Hide Description Platinum sensitive = a platinum-free interval between 6 and 12 months.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients
Arm/Group Title Enzastaurin
Hide Arm/Group Description:
Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
Overall Number of Participants Analyzed 27
Measure Type: Count of Participants
Unit of Measure: Participants
Platinum Sensitive 11
Not Platinum Sensitive 16
7.Secondary Outcome
Title Prognostic Factor - Initial Performance Status
Hide Description 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
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients
Arm/Group Title Enzastaurin
Hide Arm/Group Description:
Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
Overall Number of Participants Analyzed 27
Measure Type: Count of Participants
Unit of Measure: Participants
Performance Status = 0 16
Performance Status = 1 11
8.Secondary Outcome
Title Prognostic Factor - Age at Study Entry
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated patients
Arm/Group Title Enzastaurin
Hide Arm/Group Description:
Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
Overall Number of Participants Analyzed 27
Median (Inter-Quartile Range)
Unit of Measure: years
59
(53 to 71)
Time Frame Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Enzastaurin
Hide Arm/Group Description Loading dose of Enzastaurin 375 mg TID within 30 minutes after each meal on Day 1 followed by continuous treatment with Enzastaurin 500 mg daily within 30 minutes after the same largest meal until disease progression or adverse effects prohibit further therapy. One cycle = 28 days.
All-Cause Mortality
Enzastaurin
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Enzastaurin
Affected / at Risk (%)
Total   12/27 (44.44%) 
Gastrointestinal disorders   
Obstruction, Gi - Rectum * 1  1/27 (3.70%) 
Obstruction, Gi - Colon * 1  1/27 (3.70%) 
Ascites * 1  1/27 (3.70%) 
Dehydration * 1  1/27 (3.70%) 
Constipation * 1  1/27 (3.70%) 
General disorders   
Death No Ctcae Term - Disease Progression Nos * 1  3/27 (11.11%) 
Pain: Abdominal Pain Nos * 1  2/27 (7.41%) 
Metabolism and nutrition disorders   
Hyperkalemia * 1  1/27 (3.70%) 
Respiratory, thoracic and mediastinal disorders   
Atelectasis * 1  1/27 (3.70%) 
Aspiration * 1  1/27 (3.70%) 
Dyspnea * 1  1/27 (3.70%) 
Vascular disorders   
Thrombosis/Thrombus/Embolism * 1  1/27 (3.70%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Enzastaurin
Affected / at Risk (%)
Total   27/27 (100.00%) 
Blood and lymphatic system disorders   
Neutrophils * 1  1/27 (3.70%) 
Platelets * 1  3/27 (11.11%) 
Leukocytes * 1  3/27 (11.11%) 
Lymphopenia * 1  1/27 (3.70%) 
Hemoglobin * 1  19/27 (70.37%) 
Edema: Limb * 1  8/27 (29.63%) 
Edema: Head And Neck * 1  1/27 (3.70%) 
Cardiac disorders   
Palpitations * 1  1/27 (3.70%) 
Hypertension * 1  2/27 (7.41%) 
Endocrine disorders   
Hot Flashes * 1  2/27 (7.41%) 
Diabetes * 1  1/27 (3.70%) 
Gastrointestinal disorders   
Obstruction, Gi - Colon * 1  1/27 (3.70%) 
Heartburn * 1  2/27 (7.41%) 
Ascites * 1  4/27 (14.81%) 
Ileus * 1  1/27 (3.70%) 
Dysphagia * 1  1/27 (3.70%) 
Distention * 1  3/27 (11.11%) 
Taste Alteration * 1  2/27 (7.41%) 
Incontinence, Anal * 1  1/27 (3.70%) 
Dry Mouth * 1  3/27 (11.11%) 
Obstruction, Gi - Small Bowel Nos * 1  2/27 (7.41%) 
Vomiting * 1  9/27 (33.33%) 
Anorexia * 1  12/27 (44.44%) 
Dehydration * 1  1/27 (3.70%) 
Constipation * 1  12/27 (44.44%) 
Nausea * 1  11/27 (40.74%) 
Gastrointestinal - Other * 1  1/27 (3.70%) 
Diarrhea * 1  13/27 (48.15%) 
General disorders   
Sweating * 1  2/27 (7.41%) 
Weight Gain * 1  1/27 (3.70%) 
Fever * 1  1/27 (3.70%) 
Weight Loss * 1  1/27 (3.70%) 
Fatigue * 1  20/27 (74.07%) 
Insomnia * 1  4/27 (14.81%) 
Pain: Pelvis * 1  1/27 (3.70%) 
Pain: Breast * 1  1/27 (3.70%) 
Pain: Chest /Thorax Nos * 1  1/27 (3.70%) 
Pain: Head/Headache * 1  3/27 (11.11%) 
Pain: Extremity-Limb * 1  1/27 (3.70%) 
Pain: Joint * 1  3/27 (11.11%) 
Pain: Bone * 1  1/27 (3.70%) 
Pain: Rectum * 1  1/27 (3.70%) 
Pain: Abdominal Pain Nos * 1  11/27 (40.74%) 
Pain: Tumor * 1  1/27 (3.70%) 
Pain: Muscle * 1  3/27 (11.11%) 
Flu-Like Syndrome * 1  1/27 (3.70%) 
Immune system disorders   
Rhinitis * 1  4/27 (14.81%) 
Infections and infestations   
Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos * 1  1/27 (3.70%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Pleura * 1  1/27 (3.70%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Blood * 1  1/27 (3.70%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Wound * 1  1/27 (3.70%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis) * 1  1/27 (3.70%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Catheter-Related * 1  1/27 (3.70%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Colon * 1  1/27 (3.70%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos * 1  5/27 (18.52%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Vagina * 1  1/27 (3.70%) 
Inf W/Gr 3 Or 4 Anc: Vulva * 1  1/27 (3.70%) 
Metabolism and nutrition disorders   
Ast * 1  2/27 (7.41%) 
Gfr * 1  3/27 (11.11%) 
Creatinine * 1  4/27 (14.81%) 
Hypoalbuminemia * 1  5/27 (18.52%) 
Alt * 1  1/27 (3.70%) 
Alkaline Phosphatase * 1  3/27 (11.11%) 
Hypophosphatemia * 1  2/27 (7.41%) 
Hyponatremia * 1  6/27 (22.22%) 
Hypertriglyceridemia * 1  1/27 (3.70%) 
Hypernatremia * 1  1/27 (3.70%) 
Hypocalcemia * 1  3/27 (11.11%) 
Hyperkalemia * 1  3/27 (11.11%) 
Hyperglycemia * 1  4/27 (14.81%) 
Hypokalemia * 1  3/27 (11.11%) 
Hypoglycemia * 1  1/27 (3.70%) 
Hypomagnesemia * 1  4/27 (14.81%) 
Nervous system disorders   
Mood Alteration - Depression * 1  2/27 (7.41%) 
Mood Alteration - Anxiety * 1  2/27 (7.41%) 
Tremor * 1  1/27 (3.70%) 
Somnolence * 1  1/27 (3.70%) 
Dizziness * 1  2/27 (7.41%) 
Neuropathy-Sensory * 1  1/27 (3.70%) 
Neuropathy-Motor * 1  1/27 (3.70%) 
Renal and urinary disorders   
Renal/Genitourinary - Other * 1  1/27 (3.70%) 
Urinary Color Change * 1  3/27 (11.11%) 
Reproductive system and breast disorders   
Vaginal Dryness * 1  1/27 (3.70%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary: Other * 1  1/27 (3.70%) 
Cough * 1  2/27 (7.41%) 
Dyspnea * 1  12/27 (44.44%) 
Skin and subcutaneous tissue disorders   
Hair Loss/Alopecia (Scalp Or Body) * 1  2/27 (7.41%) 
Acne * 1  1/27 (3.70%) 
Rash * 1  3/27 (11.11%) 
Dry Skin * 1  2/27 (7.41%) 
Decubitus * 1  1/27 (3.70%) 
Ulceration * 1  1/27 (3.70%) 
Vascular disorders   
Hemorrhage, Gu - Vagina * 1  1/27 (3.70%) 
Hemorrhage, Gi - Rectum * 1  1/27 (3.70%) 
Hemorrhage, Gi - Upper Gi Nos * 1  1/27 (3.70%) 
Hemorrhage/Pulmonary - Nose * 1  1/27 (3.70%) 
Petechiae * 1  1/27 (3.70%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Angela Kuras on behalf of Mike Sill, PhD
Organization: NRG Oncology
Phone: 716-845-5702
EMail: kurasa@nrgoncology.org
Layout table for additonal information
Responsible Party: GOG Foundation ( Gynecologic Oncology Group )
ClinicalTrials.gov Identifier: NCT00407758    
Other Study ID Numbers: GOG-0170J
CDR0000517318
LILLY-H6Q-MC-S025
First Submitted: December 4, 2006
First Posted: December 5, 2006
Results First Submitted: August 1, 2017
Results First Posted: November 21, 2017
Last Update Posted: March 20, 2019