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Trial record 1 of 9 for:    decitabine AND ovarian cancer
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Trial of Decitabine as a Sensitizer to Carboplatin in Platinum Resistant Recurrent Ovarian 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: NCT00477386
Recruitment Status : Completed
First Posted : May 23, 2007
Results First Posted : September 25, 2014
Last Update Posted : September 25, 2014
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
Indiana University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ovarian Cancer
Intervention Drug: decitabine
Enrollment 28
Recruitment Details Eleven patients were enrolled in the dosing finding Phase I part of the study. The Phase II dose treatment phase had 17 patients enrolled. This was in line with what had been planned.
Pre-assignment Details  
Arm/Group Title Phase I Dose Finding Phase II
Hide Arm/Group Description Decitabine at escalating dose levels will be given IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5. Decitabine at 10 mg/m2 will be given by IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
Period Title: Overall Study
Started 11 17
Completed 0 0
Not Completed 11 17
Reason Not Completed
Adverse Event             4             8
Disease progression, relapse             3             4
Disease progression, refractory             1             3
Other             1             2
Physician Decision             1             0
Withdrawal by Subject             1             0
Arm/Group Title Phase I Dose Finding Phase II Total
Hide Arm/Group Description Decitabine at escalating dose levels will be given IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5. Decitabine at 10 mg/m2 will be given by IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5. Total of all reporting groups
Overall Number of Baseline Participants 11 17 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 17 participants 28 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
  63.6%
10
  58.8%
17
  60.7%
>=65 years
4
  36.4%
7
  41.2%
11
  39.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 17 participants 28 participants
60.8  (7.8) 61.4  (10.9) 61.2  (9.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 17 participants 28 participants
Female
11
 100.0%
17
 100.0%
28
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 17 participants 28 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
11
 100.0%
17
 100.0%
28
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 17 participants 28 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
11
 100.0%
17
 100.0%
28
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Phase I: Maximum Tolerated Dose (MTD) for Use in Phase II
Hide Description The definition of MTD will follow the standard definition of the phase I 3+3 trial concept. Dose Limiting Toxicities (DLTs) will be scored in the first cycle. Patients will be monitored for 28 days (a cycle) to determine whether a DLT is experienced for the specific dose level.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
All patients assigned to Phase I of the study
Arm/Group Title Phase I Dose Finding
Hide Arm/Group Description:
Decitabine at escalating dose levels will be given IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: mg/m2 IV QD x 5 days
10
2.Primary Outcome
Title Phase II: Percent of Patients With Objective Response
Hide Description The percent of patients having an objective response (Complete Response or Partial Response) will be estimated with a 95% exact binomial confidence interval for the percent of patients receiving drug.
Time Frame screening until end of study (approx 12-18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All Patients in Phase II of the study
Arm/Group Title Phase II Dose Treatment
Hide Arm/Group Description:
Decitabine at 10 mg/m2 will be given by IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
Overall Number of Participants Analyzed 17
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of participants
35.3
(14.2 to 61.7)
3.Secondary Outcome
Title Phase II: Percent of Patients With Objective Response, CA125 Response or Stable Disease > 3 Months
Hide Description The percent of patients having an objective response (Complete Response or Partial Response) or CA125 response (Complete Response or Partial Response) or stable disease > 3 months will be estimated with a 95% exact binomial confidence interval for the percent of patients receiving drug.
Time Frame screening until end of study (approx 12-18 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All Patients in Phase II of the study
Arm/Group Title Phase II Dose Treatment
Hide Arm/Group Description:
Decitabine at 10 mg/m2 will be given by IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
Overall Number of Participants Analyzed 17
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of patients
70.6
(44.0 to 89.7)
4.Secondary Outcome
Title Phase II: Progression Free Survival
Hide Description Progression free survival times will be estimated using the Kaplan-Meier method. If a patient progresses or dies, the time till that event will be used. If a patient does not progress or die on the study, the patient will be censored at the last available visit. Confidence intervals on the median will be constructed.
Time Frame Baseline until disease progression or last visit
Hide Outcome Measure Data
Hide Analysis Population Description
All Patients in Phase II of the study
Arm/Group Title Phase II Dose Treatment
Hide Arm/Group Description:
Decitabine at 10 mg/m2 will be given by IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
Overall Number of Participants Analyzed 17
Median (95% Confidence Interval)
Unit of Measure: Months
10.2
(1.8 to 14.8)
Time Frame The AEs were collected from beginning of treatment until the end of study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phase I Dosing Finding Phase II
Hide Arm/Group Description Decitabine at escalating dose levels will be given IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5. Decitabine at 10 mg/m2 will be given by IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
All-Cause Mortality
Phase I Dosing Finding Phase II
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Phase I Dosing Finding Phase II
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/11 (27.27%)      4/17 (23.53%)    
Gastrointestinal disorders     
CONSTIPATION * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
OBSTRUCTION, GI - SMALL BOWEL NOS * 1  1/11 (9.09%)  1 0/17 (0.00%)  0
HEMORRHAGE, GI - ABDOMEN NOS * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
LEAK (INCLUDING ANASTOMOTIC), GI - SMALL BOWEL * 1  1/11 (9.09%)  1 0/17 (0.00%)  0
OBSTRUCTION, GI - DUODENUM * 1  1/11 (9.09%)  1 0/17 (0.00%)  0
General disorders     
EDEMA: LIMB * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN WITHOUT CLINICALLY OR MICROBIOLOGICALLY DOCUMENTED INFE * 1  1/11 (9.09%)  1 1/17 (5.88%)  1
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L) * 1  1/11 (9.09%)  1 0/17 (0.00%)  0
PAIN - HEAD/HEADACHE * 1  1/11 (9.09%)  1 0/17 (0.00%)  0
PAIN - STOMACH * 1  1/11 (9.09%)  1 0/17 (0.00%)  0
Infections and infestations     
INFECTION WITH UNKNOWN ANC - SKIN (CELLULITIS) * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
Investigations     
NEUTROPHILS/GRANULOCYTES (ANC/AGC) * 1  1/11 (9.09%)  1 1/17 (5.88%)  1
Respiratory, thoracic and mediastinal disorders     
PULMONARY/UPPER RESPIRATORY - OTHER (SPECIFY, __) * 1  1/11 (9.09%)  1 0/17 (0.00%)  0
PLEURAL EFFUSION (NON-MALIGNANT) * 1  1/11 (9.09%)  1 0/17 (0.00%)  0
Vascular disorders     
THROMBOSIS/THROMBUS/EMBOLISM * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 9
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Phase I Dosing Finding Phase II
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/11 (90.91%)      17/17 (100.00%)    
Blood and lymphatic system disorders     
LEUKOCYTES (TOTAL WBC) * 1  0/11 (0.00%)  0 2/17 (11.76%)  2
LYMPHATICS - OTHER (SPECIFY, __) * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
Cardiac disorders     
PERICARDIAL EFFUSION (NON-MALIGNANT) * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
VENTRICULAR ARRHYTHMIA - VENTRICULAR TACHYCARDIA * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
Endocrine disorders     
ENDOCRINE - OTHER (SPECIFY, __) * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
Gastrointestinal disorders     
CONSTIPATION * 1  2/11 (18.18%)  2 9/17 (52.94%)  9
DIARRHEA * 1  2/11 (18.18%)  2 5/17 (29.41%)  5
DISTENSION/BLOATING, ABDOMINAL * 1  2/11 (18.18%)  2 3/17 (17.65%)  3
GASTROINTESTINAL - OTHER (SPECIFY, __) * 1  1/11 (9.09%)  1 1/17 (5.88%)  1
HEARTBURN/DYSPEPSIA * 1  0/11 (0.00%)  0 2/17 (11.76%)  2
NAUSEA * 1  8/11 (72.73%)  8 12/17 (70.59%)  12
OBSTRUCTION, GI - SMALL BOWEL NOS * 1  1/11 (9.09%)  1 0/17 (0.00%)  0
TASTE ALTERATION (DYSGEUSIA) * 1  0/11 (0.00%)  0 3/17 (17.65%)  3
VOMITING * 1  5/11 (45.45%)  5 5/17 (29.41%)  5
General disorders     
CONSTITUTIONAL SYMPTOMS - OTHER (SPECIFY, __) * 1  0/11 (0.00%)  0 2/17 (11.76%)  2
EDEMA: LIMB * 1  2/11 (18.18%)  2 3/17 (17.65%)  3
FATIGUE (ASTHENIA, LETHARGY, MALAISE) * 1  5/11 (45.45%)  5 6/17 (35.29%)  6
FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN WITHOUT CLINICALLY OR MICROBIOLOGICALLY DOCUMENTED INFE * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L) * 1  1/11 (9.09%)  1 3/17 (17.65%)  3
PAIN - ABDOMEN NOS * 1  3/11 (27.27%)  3 7/17 (41.18%)  7
PAIN - BACK * 1  1/11 (9.09%)  1 4/17 (23.53%)  4
PAIN - BONE * 1  1/11 (9.09%)  1 2/17 (11.76%)  2
PAIN - CHEST WALL * 1  0/11 (0.00%)  0 2/17 (11.76%)  2
PAIN - EXTERNAL EAR * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
PAIN - EXTREMITY-LIMB * 1  1/11 (9.09%)  1 2/17 (11.76%)  2
PAIN - HEAD/HEADACHE * 1  2/11 (18.18%)  2 3/17 (17.65%)  3
PAIN - MUSCLE * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
PAIN - NECK * 1  0/11 (0.00%)  0 2/17 (11.76%)  2
PAIN - PAIN NOS * 1  0/11 (0.00%)  0 3/17 (17.65%)  3
PAIN - PELVIS * 1  0/11 (0.00%)  0 2/17 (11.76%)  2
PAIN - STOMACH * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
Immune system disorders     
ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER) * 1  6/11 (54.55%)  6 8/17 (47.06%)  8
Infections and infestations     
INFECTION - OTHER (SPECIFY, __) * 1  1/11 (9.09%)  1 1/17 (5.88%)  1
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - BLADDER (URINARY) * 1  1/11 (9.09%)  1 0/17 (0.00%)  0
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - SINUS * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
INFECTION WITH UNKNOWN ANC - BLADDER (URINARY) * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
INFECTION WITH UNKNOWN ANC - LUNG (PNEUMONIA) * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
INFECTION WITH UNKNOWN ANC - NOSE * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
INFECTION WITH UNKNOWN ANC - SINUS * 1  0/11 (0.00%)  0 3/17 (17.65%)  3
INFECTION WITH UNKNOWN ANC - SKIN (CELLULITIS) * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
INFECTION WITH UNKNOWN ANC - UPPER AIRWAY NOS * 1  1/11 (9.09%)  1 0/17 (0.00%)  0
Investigations     
ALKALINE PHOSPHATASE * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
HEMOGLOBIN * 1  0/11 (0.00%)  0 5/17 (29.41%)  5
NEUTROPHILS/GRANULOCYTES (ANC/AGC) * 1  6/11 (54.55%)  6 5/17 (29.41%)  5
PLATELETS * 1  0/11 (0.00%)  0 4/17 (23.53%)  4
WEIGHT LOSS * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
Metabolism and nutrition disorders     
ANOREXIA * 1  5/11 (45.45%)  5 5/17 (29.41%)  5
MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA) * 1  0/11 (0.00%)  0 4/17 (23.53%)  4
POTASSIUM, SERUM-LOW (HYPOKALEMIA) * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
Musculoskeletal and connective tissue disorders     
FRACTURE * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
JOINT-EFFUSION * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
JOINT-FUNCTION * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - WHOLE BODY/GENERALIZED * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
MUSCULOSKELETAL/SOFT TISSUE - OTHER (SPECIFY, __) * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
Nervous system disorders     
COGNITIVE DISTURBANCE * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
DIZZINESS * 1  1/11 (9.09%)  1 3/17 (17.65%)  3
MEMORY IMPAIRMENT * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
NEUROPATHY: CRANIAL - CN V MOTOR-JAW MUSCLES; SENSORY-FACIAL * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
NEUROPATHY: MOTOR * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
NEUROPATHY: SENSORY * 1  2/11 (18.18%)  2 5/17 (29.41%)  5
SPEECH IMPAIRMENT (E.G., DYSPHASIA OR APHASIA) * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
SYNCOPE (FAINTING) * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
Psychiatric disorders     
INSOMNIA * 1  1/11 (9.09%)  1 3/17 (17.65%)  3
MOOD ALTERATION - ANXIETY * 1  1/11 (9.09%)  1 0/17 (0.00%)  0
MOOD ALTERATION - DEPRESSION * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
PSYCHOSIS (HALLUCINATIONS/DELUSIONS) * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
Renal and urinary disorders     
HEMORRHAGE, GU - URINARY NOS * 1  1/11 (9.09%)  1 0/17 (0.00%)  0
INCONTINENCE, URINARY * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
RENAL/GENITOURINARY - OTHER (SPECIFY, __) * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
URINARY FREQUENCY/URGENCY * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
Reproductive system and breast disorders     
HOT FLASHES/FLUSHES * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
LEAK (INCLUDING ANASTOMOTIC), GU - VAGINA * 1  1/11 (9.09%)  1 0/17 (0.00%)  0
VAGINAL DISCHARGE (NON-INFECTIOUS) * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
Respiratory, thoracic and mediastinal disorders     
COUGH * 1  1/11 (9.09%)  1 6/17 (35.29%)  6
DYSPNEA (SHORTNESS OF BREATH) * 1  0/11 (0.00%)  0 3/17 (17.65%)  3
NASAL CAVITY/PARANASAL SINUS REACTIONS * 1  0/11 (0.00%)  0 2/17 (11.76%)  2
PULMONARY/UPPER RESPIRATORY - OTHER (SPECIFY, __) * 1  0/11 (0.00%)  0 2/17 (11.76%)  2
VOICE CHANGES/DYSARTHRIA (E.G., HOARSENESS, LOSS OR ALTERATION IN VOICE, LARYNGITIS) * 1  1/11 (9.09%)  1 0/17 (0.00%)  0
Skin and subcutaneous tissue disorders     
BRUISING (IN ABSENCE OF GRADE 3 OR 4 THROMBOCYTOPENIA) * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
DERMATOLOGY/SKIN - OTHER (SPECIFY, __) * 1  0/11 (0.00%)  0 2/17 (11.76%)  2
FLUSHING * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
HAIR LOSS/ALOPECIA (SCALP OR BODY) * 1  2/11 (18.18%)  2 1/17 (5.88%)  1
PRURITUS/ITCHING * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
RASH/DESQUAMATION * 1  2/11 (18.18%)  2 3/17 (17.65%)  3
RASH: ACNE/ACNEIFORM * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
SKIN BREAKDOWN/DECUBITUS ULCER * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
SWEATING (DIAPHORESIS) * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
Vascular disorders     
HYPERTENSION * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
HYPOTENSION * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
PHLEBITIS (INCLUDING SUPERFICIAL THROMBOSIS) * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
VASCULAR - OTHER (SPECIFY, __) * 1  0/11 (0.00%)  0 1/17 (5.88%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA version 9
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Daniela Matai, MD
Organization: IndianaU
Phone: 317-944-0920
EMail: dmatai@iupui.edu
Layout table for additonal information
Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00477386    
Other Study ID Numbers: 0704-07 IUCRO-0185
First Submitted: May 21, 2007
First Posted: May 23, 2007
Results First Submitted: September 19, 2014
Results First Posted: September 25, 2014
Last Update Posted: September 25, 2014