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A Multi-Histology Phase II Study of 5-Fluoro-2'-Deoxycytidine With Tetrahydrouridine (FdCyd + THU)

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: NCT00978250
Recruitment Status : Completed
First Posted : September 16, 2009
Results First Posted : December 27, 2019
Last Update Posted : December 27, 2019
Sponsor:
Information provided by (Responsible Party):
James Doroshow, M.D., National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Head and Neck Neoplasms
Lung Neoplasms
Urinary Bladder Neoplasms
Breast Neoplasms
Intervention Drug: 5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU)
Enrollment 95
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Non-Small Cell Lung Cancer Stratum Breast Cancer Stratum Bladder Cancer Stratum Head and Neck Cancer Stratum
Hide Arm/Group Description FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles. FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles. FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles. FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles.
Period Title: Overall Study
Started 25 30 18 22
Completed 25 29 18 21
Not Completed 0 1 0 1
Reason Not Completed
Late determination of ineligibility             0             1             0             1
Arm/Group Title Non-Small Cell Lung Cancer Stratum Breast Cancer Stratum Bladder Cancer Stratum Head and Neck Cancer Stratum Total
Hide Arm/Group Description

FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles

5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of DNMT, and in turn DNA methylation,can result in the re-expression of tumor suppressor genes.

FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles

5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of DNMT, and in turn DNA methylation,can result in the re-expression of tumor suppressor genes.

FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles

5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of DNMT, and in turn DNA methylation,can result in the re-expression of tumor suppressor genes.

FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles

5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of DNMT, and in turn DNA methylation,can result in the re-expression of tumor suppressor genes.

Total of all reporting groups
Overall Number of Baseline Participants 25 30 18 22 95
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 30 participants 18 participants 22 participants 95 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
17
  68.0%
24
  80.0%
4
  22.2%
16
  72.7%
61
  64.2%
>=65 years
8
  32.0%
6
  20.0%
14
  77.8%
6
  27.3%
34
  35.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 30 participants 18 participants 22 participants 95 participants
59.92  (9.95) 56.04  (10.07) 67.77  (8.93) 55.17  (11.70) 59.08  (11.08)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 30 participants 18 participants 22 participants 95 participants
Female
9
  36.0%
30
 100.0%
3
  16.7%
3
  13.6%
45
  47.4%
Male
16
  64.0%
0
   0.0%
15
  83.3%
19
  86.4%
50
  52.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 30 participants 18 participants 22 participants 95 participants
Hispanic or Latino
0
   0.0%
10
  33.3%
1
   5.6%
2
   9.1%
13
  13.7%
Not Hispanic or Latino
25
 100.0%
20
  66.7%
17
  94.4%
20
  90.9%
82
  86.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 30 participants 18 participants 22 participants 95 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
6
  24.0%
3
  10.0%
3
  16.7%
3
  13.6%
15
  15.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  12.0%
4
  13.3%
0
   0.0%
2
   9.1%
9
   9.5%
White
16
  64.0%
22
  73.3%
15
  83.3%
17
  77.3%
70
  73.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   3.3%
0
   0.0%
0
   0.0%
1
   1.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 25 participants 30 participants 18 participants 22 participants 95 participants
25
 100.0%
30
 100.0%
18
 100.0%
22
 100.0%
95
 100.0%
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description Progression-free survival (PFS) is defined as the time interval from start of treatment to documented evidence of disease progression. Disease progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum of the LD recorded since the treatment started or the appearance of one or more new lesions.
Time Frame until subject progressed or went off study for other reasons (up to approximately 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
All 93 patients eligible for the study were assessed for PFS, including patients with advanced non-small cell lung cancer, breast cancer, bladder cancer, or head and neck cancer. Two patients were determined ineligible for the study and never received study drug.
Arm/Group Title Non-Small Cell Cancer Stratum Breast Cancer Stratum Bladder Cancer Stratum Heand and Neck Cancer Stratum
Hide Arm/Group Description:

FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles

5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of daunomycin DNMT, and in turn DNA methylation, can result in the re-expression of tumor suppressor genes.

FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles

5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of daunomycin DNMT, and in turn DNA methylation, can result in the re-expression of tumor suppressor genes.

FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles

5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of daunomycin DNMT, and in turn DNA methylation, can result in the re-expression of tumor suppressor genes.

FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles

5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of daunomycin DNMT, and in turn DNA methylation, can result in the re-expression of tumor suppressor genes.

Overall Number of Participants Analyzed 25 29 18 21
Median (95% Confidence Interval)
Unit of Measure: months
2.3
(1.6 to 3.9)
3.7
(1.8 to 5.3)
3.6
(1.7 to 8.0)
1.7
(1.7 to 4.5)
2.Primary Outcome
Title Percentage of Participants With (Complete Response (CR) + Partial Response (PR)) to 5-Fluro-2'-Deoxycytidine (FdCyd)
Hide Description Response was measured using the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of the LD.
Time Frame until subject progressed or went off study for other reasons (up to approximately 1 year)
Hide Outcome Measure Data
Hide Analysis Population Description
All 93 patients eligible for the study were assessed for complete response (CR) or partial response (PR), including patients with advanced non-small cell lung cancer, breast cancer, bladder cancer, or head and neck cancer. Two patients were determined ineligible for the study and never received study drug.
Arm/Group Title Non-Small Cell Cancer Stratum Breast Cancer Stratum Bladder Cancer Stratum Head and Neck Cancer Stratum
Hide Arm/Group Description:

FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles

5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of DNMT, and in turn DNA methylation, can result in the re-expression of tumor suppressor genes.

FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles

5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of DNMT, and in turn DNA methylation, can result in the re-expression of tumor suppressor genes.

FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles

5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of DNMT, and in turn DNA methylation, can result in the re-expression of tumor suppressor genes.

FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles

5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of DNMT, and in turn DNA methylation, can result in the re-expression of tumor suppressor genes.

Overall Number of Participants Analyzed 25 29 18 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.0
(0.0 to 13.7)
6.9
(0.8 to 22.8)
5.6
(0.1 to 27.3)
0.0
(0.0 to 16.1)
3.Secondary Outcome
Title Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0).
Hide Description Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time Frame Date treatment consent signed to date off study, approximately 109 months and 16 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Two patients were determined ineligible for the study and never received study drug. Adverse Events are not being reported by stratum because this was not specified in the protocol.
Arm/Group Title 5-Fluro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU)
Hide Arm/Group Description:

FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles

5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of DNMT, and in turn DNA methylation, can result in the re-expression of tumor suppressor genes.

Overall Number of Participants Analyzed 93
Measure Type: Count of Participants
Unit of Measure: Participants
91
  97.8%
Time Frame Date treatment consent signed to date off study, approximately 109 months and 16 days. Two patients were determined ineligible for the study and never received study drug.
Adverse Event Reporting Description Adverse Events are not being reported by stratum because this was not specified in the protocol.
 
Arm/Group Title 5-Fluro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU)
Hide Arm/Group Description

FdCyd (100 mg/m(2)) + THU (350 mg/m(2)) administered 5 days/week for 2 weeks in 28-day cycles

5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU): FdCyd, a fluoropyrimidine nucleoside analog, has a short (10-minute) half-life and is rapidly degraded in vivo by cytidine deaminase. However, co-administration with THU, an inhibitor of cytidine/deoxycytidine deaminase, has been shown to increase the area under the curve (AUC) of the parent compound more than 4-fold. Increased FdCyd exposure allows it to be taken up intracellularly and converted to its triphosphate, which is incorporated into deoxyribonucleic acid (DNA) and inhibits the action of the enzyme DNA methyltransferase (DNMT). Inhibition of DNMT, and in turn DNA methylation, can result in the re-expression of tumor suppressor genes.

All-Cause Mortality
5-Fluro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU)
Affected / at Risk (%)
Total   8/93 (8.60%)    
Hide Serious Adverse Events
5-Fluro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU)
Affected / at Risk (%) # Events
Total   38/93 (40.86%)    
Blood and lymphatic system disorders   
Anemia  1  4/93 (4.30%)  5
Febrile neutropenia  1  1/93 (1.08%)  1
Cardiac disorders   
Atrial fibrillation  1  1/93 (1.08%)  1
Cardiac arrest  1  1/93 (1.08%)  1
Eye disorders   
Retinopathy  1  1/93 (1.08%)  1
Gastrointestinal disorders   
Abdominal distension  1  1/93 (1.08%)  1
Abdominal pain  1  6/93 (6.45%)  7
Colitis  1  1/93 (1.08%)  1
Constipation  1  1/93 (1.08%)  1
Diarrhea  1  4/93 (4.30%)  6
Duodenal ulcer  1  1/93 (1.08%)  1
Dysphagia  1  4/93 (4.30%)  4
Esophagitis  1  1/93 (1.08%)  1
Gastrointestinal disorders - Other, Diverticulitis  1  1/93 (1.08%)  1
Ileus  1  1/93 (1.08%)  1
Mucositis oral  1  2/93 (2.15%)  2
Nausea  1  3/93 (3.23%)  4
Oral hemorrhage  1  1/93 (1.08%)  1
Vomiting  1  4/93 (4.30%)  5
Gastrointestinal disorders - Other, Pyloric ulcer  1  1/93 (1.08%)  1
Gastrointestinal disorders - Other, Partial small bowel obstruction  1  1/93 (1.08%)  1
General disorders   
Death NOS  1  3/93 (3.23%)  3
Fatigue  1  5/93 (5.38%)  5
Fever  1  3/93 (3.23%)  3
Multi-organ failure  1  1/93 (1.08%)  1
Infections and infestations   
Enterocolitis infectious  1  1/93 (1.08%)  1
Infections and infestations - Other, port infection (right)  1  1/93 (1.08%)  1
Lung infection  1  3/93 (3.23%)  3
Mucosal infection  1  1/93 (1.08%)  1
Sepsis  1  1/93 (1.08%)  1
Upper respiratory infection  1  1/93 (1.08%)  1
Urinary tract infection  1  2/93 (2.15%)  2
Infections and infestations - Other, Clostridium difficile  1  1/93 (1.08%)  1
Infections and infestations - Other, Viral syndrome  1  1/93 (1.08%)  1
Injury, poisoning and procedural complications   
Vascular access complication  1  1/93 (1.08%)  1
Investigations   
Alkaline phosphatase increased  1  1/93 (1.08%)  1
Lymphocyte count decreased  1  6/93 (6.45%)  6
Neutrophil count decreased  1  4/93 (4.30%)  6
Platelet count decreased  1  3/93 (3.23%)  6
Weight loss  1  1/93 (1.08%)  1
White blood cell decreased  1  5/93 (5.38%)  6
Metabolism and nutrition disorders   
Anorexia  1  2/93 (2.15%)  3
Dehydration  1  3/93 (3.23%)  4
Hypercalcemia  1  3/93 (3.23%)  4
Hypermagnesemia  1  1/93 (1.08%)  1
Hypoalbuminemia  1  1/93 (1.08%)  1
Hypokalemia  1  3/93 (3.23%)  3
Hyponatremia  1  1/93 (1.08%)  1
Hypophosphatemia  1  2/93 (2.15%)  3
Musculoskeletal and connective tissue disorders   
Back pain  1  1/93 (1.08%)  1
Generalized muscle weakness  1  2/93 (2.15%)  2
Myalgia  1  1/93 (1.08%)  1
Non-cardiac chest pain  1  1/93 (1.08%)  1
Pain in extremity  1  1/93 (1.08%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1 [1]  3/93 (3.23%)  3
Tumor pain  1  1/93 (1.08%)  1
Nervous system disorders   
Cognitive disturbance  1  1/93 (1.08%)  1
Nervous system disorders - Other, Bilateral lower extremity weakness/paraplegia  1  1/93 (1.08%)  1
Syncope  1  1/93 (1.08%)  1
Psychiatric disorders   
Agitation  1  1/93 (1.08%)  1
Anxiety  1  1/93 (1.08%)  1
Renal and urinary disorders   
Acute kidney injury  1  2/93 (2.15%)  2
Hematuria  1  2/93 (2.15%)  2
Urinary retention  1  1/93 (1.08%)  1
Respiratory, thoracic and mediastinal disorders   
Aspiration  1  1/93 (1.08%)  2
Bronchopulmonary hemorrhage  1  1/93 (1.08%)  1
Cough  1  1/93 (1.08%)  1
Dyspnea  1  7/93 (7.53%)  7
Hypoxia  1  1/93 (1.08%)  1
Pleural effusion  1  1/93 (1.08%)  1
Skin and subcutaneous tissue disorders   
Rash maculo-papular  1  1/93 (1.08%)  1
Vascular disorders   
Thromboembolic event  1  1/93 (1.08%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
[1]
Death due to disease progression.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
5-Fluro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU)
Affected / at Risk (%) # Events
Total   91/93 (97.85%)    
Blood and lymphatic system disorders   
Anemia  1  62/93 (66.67%)  196
Blood and lymphatic system disorders - Other, Adenopathy: supraclavicular node  1  1/93 (1.08%)  1
Febrile neutropenia  1  1/93 (1.08%)  1
Lymph node pain  1  1/93 (1.08%)  1
Cardiac disorders   
Cardiac troponin I increased  1  1/93 (1.08%)  1
Electrocardiogram QT corrected interval prolonged  1  2/93 (2.15%)  3
Pericardial effusion  1  1/93 (1.08%)  1
Sinus bradycardia  1  1/93 (1.08%)  3
Sinus tachycardia  1  11/93 (11.83%)  34
Ear and labyrinth disorders   
Tinnitus  1  2/93 (2.15%)  2
Vertigo  1  1/93 (1.08%)  1
Eye disorders   
Blurred vision  1  2/93 (2.15%)  2
Cataract  1  1/93 (1.08%)  1
Dry eye  1  2/93 (2.15%)  4
Eye disorders - Other, Non-visibility spots, eye stain  1  1/93 (1.08%)  1
Eye disorders - Other, Visual changes  1  1/93 (1.08%)  1
Scleral disorder  1  1/93 (1.08%)  1
Watering eyes  1  3/93 (3.23%)  4
Gastrointestinal disorders   
Abdominal distension  1  3/93 (3.23%)  6
Abdominal pain  1  20/93 (21.51%)  34
Ascites  1  1/93 (1.08%)  4
Bloating  1  5/93 (5.38%)  5
Constipation  1  35/93 (37.63%)  47
Diarrhea  1  36/93 (38.71%)  81
Dry mouth  1  8/93 (8.60%)  10
Dyspepsia  1  1/93 (1.08%)  1
Esophageal pain  1  1/93 (1.08%)  1
Flatulence  1  2/93 (2.15%)  2
Gastritis  1  2/93 (2.15%)  3
Gastroesophageal reflux disease  1  3/93 (3.23%)  3
Gastrointestinal disorders - Other, "pin point" ulcer on tongue  1  1/93 (1.08%)  1
Gastrointestinal pain  1  1/93 (1.08%)  3
Hemorrhoidal hemorrhage  1  1/93 (1.08%)  1
Hemorrhoids  1  1/93 (1.08%)  1
Lower gastrointestinal hemorrhage  1  1/93 (1.08%)  1
Mucositis oral  1  9/93 (9.68%)  13
Nausea  1  57/93 (61.29%)  107
Oral hemorrhage  1  1/93 (1.08%)  1
Vomiting  1  27/93 (29.03%)  38
Gastrointestinal disorders - Other, Blood in stool  1  1/93 (1.08%)  1
General disorders   
Chills  1  13/93 (13.98%)  18
Edema face  1  1/93 (1.08%)  1
Edema limbs  1  23/93 (24.73%)  25
Fatigue  1  62/93 (66.67%)  188
Fever  1  23/93 (24.73%)  53
Flu like symptoms  1  6/93 (6.45%)  7
Gait disturbance  1  4/93 (4.30%)  4
Infusion related reaction  1  1/93 (1.08%)  1
Infusion site extravasation  1  2/93 (2.15%)  2
Injection site reaction  1  5/93 (5.38%)  5
Malaise  1  2/93 (2.15%)  2
Pain  1  15/93 (16.13%)  25
Hepatobiliary disorders   
Hepatobiliary disorders - Other, Cirrhosis  1  1/93 (1.08%)  1
Immune system disorders   
Allergic reaction  1  1/93 (1.08%)  1
Infections and infestations   
Abdominal infection  1  1/93 (1.08%)  1
Catheter related infection  1  1/93 (1.08%)  1
Conjunctivitis infective  1  1/93 (1.08%)  1
Enterocolitis infectious  1  1/93 (1.08%)  1
Gum infection  1  1/93 (1.08%)  1
Infections and infestations - Other, C. difficile infection  1  1/93 (1.08%)  1
Lip infection  1  1/93 (1.08%)  1
Mucosal infection  1  2/93 (2.15%)  3
Nail infection  1  1/93 (1.08%)  1
Paronychia  1  1/93 (1.08%)  1
Penile infection  1  1/93 (1.08%)  2
Sinusitis  1  1/93 (1.08%)  1
Skin infection  1  2/93 (2.15%)  3
Urinary tract infection  1  7/93 (7.53%)  10
Vaginal infection  1  1/93 (1.08%)  2
Wound infection  1  1/93 (1.08%)  1
Infections and infestations - Other, Herpes  1  1/93 (1.08%)  1
Infections and infestations - Other, Cryptosporidium  1  1/93 (1.08%)  1
Infections and infestations - Other, C. difficile colitis  1  1/93 (1.08%)  1
Infections and infestations - Other, catheter related  1  1/93 (1.08%)  1
Infections and infestations - Other, Infection with unknown ANC: Blood  1  1/93 (1.08%)  1
Infections and infestations - Other, Sinusitis  1  1/93 (1.08%)  1
Injury, poisoning and procedural complications   
Bruising  1  2/93 (2.15%)  3
Fall  1  4/93 (4.30%)  8
Investigations   
Activated partial thromboplastin time prolonged  1  12/93 (12.90%)  13
Alanine aminotransferase increased  1  34/93 (36.56%)  83
Alkaline phosphatase increased  1  26/93 (27.96%)  49
Aspartate aminotransferase increased  1  36/93 (38.71%)  78
Blood bilirubin increased  1  8/93 (8.60%)  12
CPK increased  1  4/93 (4.30%)  10
Creatinine increased  1  14/93 (15.05%)  29
Hemoglobin increased  1  2/93 (2.15%)  4
INR increased  1  4/93 (4.30%)  6
Investigations - Other, Bicarbonate, serum-low  1  4/93 (4.30%)  5
Lymphocyte count decreased  1  60/93 (64.52%)  265
Neutrophil count decreased  1  28/93 (30.11%)  76
Platelet count decreased  1  37/93 (39.78%)  91
Weight gain  1  1/93 (1.08%)  2
Weight loss  1  26/93 (27.96%)  41
White blood cell decreased  1  49/93 (52.69%)  181
Metabolism and nutrition disorders   
Anorexia  1  37/93 (39.78%)  65
Dehydration  1  12/93 (12.90%)  17
Hypercalcemia  1  17/93 (18.28%)  31
Hyperglycemia  1  10/93 (10.75%)  27
Hyperkalemia  1  8/93 (8.60%)  20
Hypermagnesemia  1  9/93 (9.68%)  12
Hypernatremia  1  4/93 (4.30%)  5
Hyperuricemia  1  2/93 (2.15%)  3
Hypoalbuminemia  1  61/93 (65.59%)  174
Hypocalcemia  1  20/93 (21.51%)  45
Hypoglycemia  1  8/93 (8.60%)  8
Hypokalemia  1  23/93 (24.73%)  47
Hypomagnesemia  1  24/93 (25.81%)  58
Hyponatremia  1  49/93 (52.69%)  115
Hypophosphatemia  1  26/93 (27.96%)  49
Musculoskeletal and connective tissue disorders   
Arthralgia  1  3/93 (3.23%)  3
Back pain  1  13/93 (13.98%)  20
Bone pain  1  4/93 (4.30%)  4
Buttock pain  1  1/93 (1.08%)  1
Chest wall pain  1  2/93 (2.15%)  6
Flank pain  1  3/93 (3.23%)  4
Generalized muscle weakness  1  6/93 (6.45%)  6
Muscle weakness lower limb  1  2/93 (2.15%)  2
Muscle weakness upper limb  1  2/93 (2.15%)  2
Musculoskeletal and connective tissue disorder - Other, locking of fingers-middle and ring  1  1/93 (1.08%)  1
Myalgia  1  6/93 (6.45%)  7
Neck pain  1  2/93 (2.15%)  2
Non-cardiac chest pain  1  3/93 (3.23%)  4
Pain in extremity  1  12/93 (12.90%)  18
Trismus  1  1/93 (1.08%)  1
Musculoskeletal and connective tissue disorder - Other, Swelling - right arm  1  1/93 (1.08%)  1
Musculoskeletal and connective tissue disorder - Other, chest tightness  1  1/93 (1.08%)  1
Musculoskeletal and connective tissue disorder - Other, hip pain  1  1/93 (1.08%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumor pain  1  3/93 (3.23%)  4
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1 [1]  1/93 (1.08%)  1
Nervous system disorders   
Cognitive disturbance  1  1/93 (1.08%)  1
Dizziness  1  12/93 (12.90%)  13
Dysarthria  1  1/93 (1.08%)  1
Dysesthesia  1  1/93 (1.08%)  1
Dysgeusia  1  9/93 (9.68%)  10
Dysphagia  1  2/93 (2.15%)  2
Headache  1  13/93 (13.98%)  16
Lethargy  1  1/93 (1.08%)  1
Memory impairment  1  2/93 (2.15%)  6
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1 [2]  1/93 (1.08%)  1
Nervous system disorders - Other, saddle anesthesia  1  1/93 (1.08%)  1
Neuralgia  1  1/93 (1.08%)  1
Paresthesia  1  1/93 (1.08%)  1
Peripheral motor neuropathy  1  1/93 (1.08%)  1
Peripheral sensory neuropathy  1  8/93 (8.60%)  14
Somnolence  1  3/93 (3.23%)  3
Stroke  1  1/93 (1.08%)  1
Syncope  1  1/93 (1.08%)  1
Tremor  1  2/93 (2.15%)  2
Nervous system disorders - Other, disk replacement  1  1/93 (1.08%)  1
Psychiatric disorders   
Agitation  1  1/93 (1.08%)  1
Anxiety  1  6/93 (6.45%)  7
Confusion  1  3/93 (3.23%)  6
Delirium  1  1/93 (1.08%)  1
Depression  1  2/93 (2.15%)  4
Insomnia  1  8/93 (8.60%)  8
Restlessness  1  1/93 (1.08%)  1
Renal and urinary disorders   
Hematuria  1  3/93 (3.23%)  4
Proteinuria  1  1/93 (1.08%)  1
Renal and urinary disorders - Other, renal insufficiency  1  1/93 (1.08%)  1
Renal calculi  1  1/93 (1.08%)  1
Urinary frequency  1  3/93 (3.23%)  4
Urinary retention  1  2/93 (2.15%)  2
Urinary tract pain  1  2/93 (2.15%)  2
Renal and urinary disorders - Other, urinary output decreased  1  1/93 (1.08%)  1
Reproductive system and breast disorders   
Genital edema  1  1/93 (1.08%)  1
Pelvic pain  1  1/93 (1.08%)  1
Reproductive system and breast disorders - Other, Orchitis  1  1/93 (1.08%)  1
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1  2/93 (2.15%)  3
Aspiration  1  1/93 (1.08%)  1
Cough  1  19/93 (20.43%)  30
Dyspnea  1  24/93 (25.81%)  37
Epistaxis  1  5/93 (5.38%)  5
Hiccups  1  1/93 (1.08%)  1
Hoarseness  1  1/93 (1.08%)  1
Hypoxia  1  2/93 (2.15%)  3
Pharyngolaryngeal pain  1  1/93 (1.08%)  1
Pleural effusion  1  5/93 (5.38%)  6
Pleuritic pain  1  3/93 (3.23%)  4
Pneumonitis  1  3/93 (3.23%)  3
Pneumothorax  1  1/93 (1.08%)  1
Productive cough  1  5/93 (5.38%)  5
Respiratory, thoracic and mediastinal disorders - Other, Difficulty breathing  1  1/93 (1.08%)  1
Sore throat  1  1/93 (1.08%)  1
Upper respiratory infection  1  3/93 (3.23%)  3
Voice alteration  1  2/93 (2.15%)  2
Wheezing  1  2/93 (2.15%)  2
Respiratory, thoracic and mediastinal disorders - Other, nasal drainage  1  1/93 (1.08%)  1
Skin and subcutaneous tissue disorders   
Alopecia  1  2/93 (2.15%)  2
Body odor  1  1/93 (1.08%)  1
Dry skin  1  8/93 (8.60%)  11
Erythema multiforme  1  1/93 (1.08%)  1
Hyperhidrosis  1  3/93 (3.23%)  3
Nail discoloration  1  1/93 (1.08%)  1
Palmar-plantar erythrodysesthesia syndrome  1  4/93 (4.30%)  5
Pruritus  1  11/93 (11.83%)  11
Rash acneiform  1  2/93 (2.15%)  2
Rash maculo-papular  1  7/93 (7.53%)  12
Skin and subcutaneous tissue disorders - Other, Blisters  1  1/93 (1.08%)  1
Skin and subcutaneous tissue disorders - Other, Folliculitis  1  1/93 (1.08%)  1
Skin and subcutaneous tissue disorders - Other, specify  1 [3]  1/93 (1.08%)  1
Skin hyperpigmentation  1  2/93 (2.15%)  2
Skin hypopigmentation  1  1/93 (1.08%)  1
Skin ulceration  1  2/93 (2.15%)  2
Urticaria  1  1/93 (1.08%)  2
Skin and subcutaneous tissue disorders - Other, facial erythema  1  1/93 (1.08%)  1
Skin and subcutaneous tissue disorders - Other, scleroderma @ hands and feet  1  1/93 (1.08%)  1
Skin and subcutaneous tissue disorders - Other, nail changes  1  1/93 (1.08%)  1
Skin and subcutaneous tissue disorders - Other, discoloration of leg  1  1/93 (1.08%)  1
Skin and subcutaneous tissue disorders - Other, rash  1  1/93 (1.08%)  1
Surgical and medical procedures   
Surgical and medical procedures - Other, hip surgery  1  1/93 (1.08%)  1
Vascular disorders   
Hot flashes  1  1/93 (1.08%)  1
Hypertension  1  29/93 (31.18%)  175
Hypotension  1  13/93 (13.98%)  21
Lymphedema  1  2/93 (2.15%)  2
Superficial thrombophlebitis  1  1/93 (1.08%)  1
Thromboembolic event  1  3/93 (3.23%)  4
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
[1]
Complex multiseptated cysts - left testicle
[2]
Drainage/bleeding @ chest mass.
[3]
Skin and subcutaneous tissue disorder
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Dr. James Doroshow
Organization: National Cancer Institute
Phone: 240-781-3320
EMail: jim_doroshow@nih.gov
Layout table for additonal information
Responsible Party: James Doroshow, M.D., National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00978250    
Other Study ID Numbers: 090214
09-C-0214
First Submitted: September 15, 2009
First Posted: September 16, 2009
Results First Submitted: December 12, 2019
Results First Posted: December 27, 2019
Last Update Posted: December 27, 2019