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Trial record 27 of 228 for:    metformin and cancer AND Hypoglycemic

Evaluation of Metformin, Targeting Cancer Stem Cells for Prevention of Relapse in Gynecologic Patients

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ClinicalTrials.gov Identifier: NCT01579812
Recruitment Status : Completed
First Posted : April 18, 2012
Results First Posted : May 25, 2018
Last Update Posted : May 25, 2018
Sponsor:
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
Intervention Drug: Metformin
Enrollment 90
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Metformin
Hide Arm/Group Description

Metformin: Patients receiving primary surgical debulking followed by adjuvant chemotherapy will initiate metformin prior to primary surgery. Following surgery patients will be initiated on metformin prior to the initiation of chemotherapy.

Patients treated with neoadjuvant chemotherapy will be initiated on metformin prior to the initiation of chemotherapy. Following surgery patients will be initiated on metformin prior to the re-initiation of chemotherapy.

Period Title: Overall Study
Started 90
Completed 38
Not Completed 52
Reason Not Completed
Ineligible after treatment start             40
Patient choice             3
Noncompliance             3
Withdrawal by Subject             6
Arm/Group Title Metformin
Hide Arm/Group Description

Metformin: Patients receiving primary surgical debulking followed by adjuvant chemotherapy will initiate metformin prior to primary surgery. Following surgery patients will be initiated on metformin prior to the initiation of chemotherapy.

Patients treated with neoadjuvant chemotherapy will be initiated on metformin prior to the initiation of chemotherapy. Following surgery patients will be initiated on metformin prior to the re-initiation of chemotherapy.

Overall Number of Baseline Participants 90
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 90 participants
58
(30 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants
Female
90
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants
Hispanic or Latino
2
   2.2%
Not Hispanic or Latino
69
  76.7%
Unknown or Not Reported
19
  21.1%
1.Primary Outcome
Title Recurrence-Free Survival
Hide Description

Determine the percentage of patients alive without recurrence at 18 months. Investigators will also determine recurrence free survival when patients with persistent disease are excluded.

Definition of progression or recurrence and survival will be defined as increasing clinical, radiological or histological evidence of disease since study entry or two serum values of CA-125 greater than or equal to two times the upper limits of normal (ULN) performed at least one week apart, regardless of CT scan results.

Recurrence-Free Interval will be defined as date from start of chemotherapy to the date of first clinical, biochemical, or radiological evidence of progression or death due to any cause.

Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
90 patients were enrolled, only 38 completed treatment and were analyzed. Patients found to have persistent disease were censored at the time they were found to have progressive disease. 11 patients had persistent disease.
Arm/Group Title Metformin - All Patients Analyzed Metformin - Patients With Persistent Disease Excluded
Hide Arm/Group Description:

Metformin: Patients receiving primary surgical debulking followed by adjuvant chemotherapy will initiate metformin prior to primary surgery. Following surgery patients will be initiated on metformin prior to the initiation of chemotherapy.

Patients treated with neoadjuvant chemotherapy will be initiated on metformin prior to the initiation of chemotherapy. Following surgery patients will be initiated on metformin prior to the re-initiation of chemotherapy.

Metformin: Patients receiving primary surgical debulking followed by adjuvant chemotherapy will initiate metformin prior to primary surgery. Following surgery patients will be initiated on metformin prior to the initiation of chemotherapy.

Patients treated with neoadjuvant chemotherapy will be initiated on metformin prior to the initiation of chemotherapy. Following surgery patients will be initiated on metformin prior to the re-initiation of chemotherapy.

Patients with persistent disease were excluded in this analysis.

Overall Number of Participants Analyzed 38 27
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
58.1
(38 to 73.8)
55.6
(35.2 to 71.8)
2.Secondary Outcome
Title Overall Survival
Hide Description Determine the median overall survival time for all patients who complete treatment as well as for patients presenting with stage IIc/ III and stage IV ovarian cancer.
Time Frame Up to 3 Years
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Hide Analysis Population Description
90 patients were enrolled and only 38 patients completed treatment. 25 of the 38 patients had stage IIc/III ovarian cancer. 13 of the 38 patients had stage IV ovarian cancer.
Arm/Group Title Metformin - All Patients Analyzed Metformin - Patients Stage IIc/ III Ovarian Cancer Metformin - Patients With Stage IV Ovarian Cancer
Hide Arm/Group Description:

Metformin: Patients receiving primary surgical debulking followed by adjuvant chemotherapy will initiate metformin prior to primary surgery. Following surgery patients will be initiated on metformin prior to the initiation of chemotherapy.

Patients treated with neoadjuvant chemotherapy will be initiated on metformin prior to the initiation of chemotherapy. Following surgery patients will be initiated on metformin prior to the re-initiation of chemotherapy.

Patients with stage IIc/ III ovarian cancer receiving primary surgical debulking followed by adjuvant chemotherapy will initiate metformin prior to primary surgery. Following surgery patients will be initiated on metformin prior to the initiation of chemotherapy.
Patients with stage IV ovarian cancer receiving primary surgical debulking followed by adjuvant chemotherapy will initiate metformin prior to primary surgery. Following surgery patients will be initiated on metformin prior to the initiation of chemotherapy.
Overall Number of Participants Analyzed 38 25 13
Median (95% Confidence Interval)
Unit of Measure: months
43
(35 to 56)
52
(35 to 65)
36
(15 to 43)
Time Frame Up to 30 days post treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Metformin
Hide Arm/Group Description

Metformin: Patients receiving primary surgical debulking followed by adjuvant chemotherapy will initiate metformin prior to primary surgery. Following surgery patients will be initiated on metformin prior to the initiation of chemotherapy.

Patients treated with neoadjuvant chemotherapy will be initiated on metformin prior to the initiation of chemotherapy. Following surgery patients will be initiated on metformin prior to the re-initiation of chemotherapy.

All-Cause Mortality
Metformin
Affected / at Risk (%)
Total   2/90 (2.22%)    
Show Serious Adverse Events Hide Serious Adverse Events
Metformin
Affected / at Risk (%) # Events
Total   26/90 (28.89%)    
Blood and lymphatic system disorders   
Anemia   6/90 (6.67%)  6
Febrile neutropenia   1/90 (1.11%)  1
Cardiac disorders   
Asystole   1/90 (1.11%)  1
Heart failure   1/90 (1.11%)  1
Sick sinus syndrome   1/90 (1.11%)  1
Supraventricular tachycardia   1/90 (1.11%)  1
Gastrointestinal disorders   
Ascites   1/90 (1.11%)  1
Gastric ulcer   1/90 (1.11%)  1
Ileus   6/90 (6.67%)  6
Small intestinal obstruction   2/90 (2.22%)  3
Upper gastrointestinal hemorrhage   1/90 (1.11%)  1
General disorders   
Non-cardiac chest pain   1/90 (1.11%)  1
Infections and infestations   
Lung infection   2/90 (2.22%)  2
Sepsis   1/90 (1.11%)  1
Wound infection   1/90 (1.11%)  1
Investigations   
Neutrophil count decreased   2/90 (2.22%)  2
Platelet count decreased   4/90 (4.44%)  4
White blood cell decreased   3/90 (3.33%)  4
Metabolism and nutrition disorders   
Dehydration   1/90 (1.11%)  1
Hypokalemia   1/90 (1.11%)  1
Hyponatremia   3/90 (3.33%)  4
Musculoskeletal and connective tissue disorders   
Back pain   1/90 (1.11%)  1
Pain in extremity   1/90 (1.11%)  1
Nervous system disorders   
Ischemia cerebrovascular   1/90 (1.11%)  1
Syncope   1/90 (1.11%)  1
Psychiatric disorders   
Anxiety   1/90 (1.11%)  1
Renal and urinary disorders   
Acute kidney injury   2/90 (2.22%)  2
Reproductive system and breast disorders   
Reproductive system and breast disorders   1/90 (1.11%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea   1/90 (1.11%)  1
Respiratory, thoracic and mediastinal disorders   1/90 (1.11%)  1
Skin and subcutaneous tissue disorders   
Toxic epidermal necrolysis   1/90 (1.11%)  1
Vascular disorders   
Hypotension   2/90 (2.22%)  2
Thromboembolic event   1/90 (1.11%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Metformin
Affected / at Risk (%) # Events
Total   40/90 (44.44%)    
Blood and lymphatic system disorders   
Anemia   26/90 (28.89%)  70
Febrile neutropenia   1/90 (1.11%)  1
Cardiac disorders   
Left ventricular systolic dysfunction   1/90 (1.11%)  1
Palpitations   1/90 (1.11%)  1
Sick sinus syndrome   1/90 (1.11%)  1
Sinus tachycardia   1/90 (1.11%)  1
Gastrointestinal disorders   
Abdominal pain   8/90 (8.89%)  8
Bloating   2/90 (2.22%)  2
Constipation   3/90 (3.33%)  3
Diarrhea   13/90 (14.44%)  19
Dyspepsia   2/90 (2.22%)  2
Ileus   1/90 (1.11%)  1
Mucositis oral   1/90 (1.11%)  1
Nausea   12/90 (13.33%)  13
Oral pain   1/90 (1.11%)  1
Rectal pain   1/90 (1.11%)  1
Stomach pain   1/90 (1.11%)  1
Vomiting   7/90 (7.78%)  7
General disorders   
Chills   1/90 (1.11%)  1
Edema limbs   1/90 (1.11%)  1
Fatigue   17/90 (18.89%)  21
Fever   2/90 (2.22%)  2
Infusion related reaction   1/90 (1.11%)  1
Non-cardiac chest pain   1/90 (1.11%)  1
Pain   4/90 (4.44%)  5
Immune system disorders   
Allergic reaction   1/90 (1.11%)  1
Infections and infestations   
Nail infection   1/90 (1.11%)  1
Otitis media   1/90 (1.11%)  1
Papulopustular rash   1/90 (1.11%)  1
Urinary tract infection   2/90 (2.22%)  2
Wound infection   1/90 (1.11%)  1
Injury, poisoning and procedural complications   
Fall   1/90 (1.11%)  1
Investigations   
Alanine aminotransferase increased   6/90 (6.67%)  7
Alkaline phosphatase increased   4/90 (4.44%)  4
Aspartate aminotransferase increased   8/90 (8.89%)  10
Creatinine increased   4/90 (4.44%)  4
Lymphocyte count decreased   1/90 (1.11%)  2
Neutrophil count decreased   12/90 (13.33%)  17
Platelet count decreased   13/90 (14.44%)  28
Weight loss   4/90 (4.44%)  4
White blood cell decreased   17/90 (18.89%)  34
Metabolism and nutrition disorders   
Alkalosis   1/90 (1.11%)  1
Anorexia   6/90 (6.67%)  6
Dehydration   1/90 (1.11%)  1
Hypercalcemia   3/90 (3.33%)  3
Hyperglycemia   7/90 (7.78%)  10
Hyperkalemia   2/90 (2.22%)  2
Hypoalbuminemia   3/90 (3.33%)  3
Hypocalcemia   1/90 (1.11%)  1
Hypoglycemia   1/90 (1.11%)  2
Hypokalemia   6/90 (6.67%)  7
Hypomagnesemia   4/90 (4.44%)  4
Hyponatremia   5/90 (5.56%)  9
Hypophosphatemia   1/90 (1.11%)  1
Musculoskeletal and connective tissue disorders   
Back pain   2/90 (2.22%)  2
Neck pain   1/90 (1.11%)  1
Pain in extremity   2/90 (2.22%)  3
Nervous system disorders   
Concentration impairment   1/90 (1.11%)  1
Dizziness   3/90 (3.33%)  4
Headache   3/90 (3.33%)  3
Paresthesia   3/90 (3.33%)  3
Peripheral motor neuropathy   6/90 (6.67%)  6
Peripheral sensory neuropathy   9/90 (10.00%)  10
Psychiatric disorders   
Anxiety   4/90 (4.44%)  4
Depression   4/90 (4.44%)  4
Insomnia   3/90 (3.33%)  3
Restlessness   1/90 (1.11%)  1
Renal and urinary disorders   
Cystitis noninfective   1/90 (1.11%)  1
Renal and urinary disorders   1/90 (1.11%)  1
Urinary incontinence   2/90 (2.22%)  2
Urinary tract pain   1/90 (1.11%)  1
Reproductive system and breast disorders   
Dyspareunia   1/90 (1.11%)  1
Vaginal hemorrhage   1/90 (1.11%)  1
Vaginal pain   1/90 (1.11%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea   1/90 (1.11%)  2
Epistaxis   1/90 (1.11%)  2
Hoarseness   1/90 (1.11%)  1
Voice alteration   1/90 (1.11%)  1
Skin and subcutaneous tissue disorders   
Alopecia   5/90 (5.56%)  7
Nail discoloration   1/90 (1.11%)  1
Pruritus   1/90 (1.11%)  1
Rash maculo-papular   4/90 (4.44%)  4
Vascular disorders   
Hot flashes   2/90 (2.22%)  2
Hypotension   1/90 (1.11%)  1
Thromboembolic event   2/90 (2.22%)  2
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Ronald Buckanovich, MD, PhD
Organization: UPMC Hillman Cancer Center
Phone: 412-641-4721
Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT01579812     History of Changes
Other Study ID Numbers: UMCC 2011.037
HUM 47900 ( Other Identifier: Univ Mich Medical School Institutional Review Board (IRBMED) )
First Submitted: March 30, 2012
First Posted: April 18, 2012
Results First Submitted: February 28, 2018
Results First Posted: May 25, 2018
Last Update Posted: May 25, 2018