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Trial record 26 of 2159 for:    doxorubicin

Pilot Study of Liposomal Doxorubicin Combined With Bevacizumab Followed by Bevacizumab Monotherapy in Adults With Advanced Kaposi s Sarcoma

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ClinicalTrials.gov Identifier: NCT00923936
Recruitment Status : Completed
First Posted : June 18, 2009
Results First Posted : June 16, 2017
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Robert Yarchoan, National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Sarcoma, Kaposi
Interventions Drug: Liposomal Doxorubicin
Drug: Bevacizumab
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title KS; Classic or HIV+ Not Improved on Antivirals All Other Advanced HIV-associated Kaposi's Sarcoma (KS)
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Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.

Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.

Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles.

All other patients with advanced AIDS-associated KS

Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.

Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles.

Period Title: Overall Study
Started 10 6
Completed 2 3
Not Completed 8 3
Reason Not Completed
progressive disease on study             2             1
Adverse Event             2             1
Lost to follow up             2             0
Continuing in follow up period             2             1
Arm/Group Title KS; Classic or HIV+ Not Improved on Antivirals All Other Advanced HIV-associated Kaposi's Sarcoma (KS) Total
Hide Arm/Group Description

Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.

Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.

Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles.

All other patients with advanced AIDS-associated KS

Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.

Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles.

Total of all reporting groups
Overall Number of Baseline Participants 10 6 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 6 participants 16 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
6
 100.0%
16
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants 6 participants 16 participants
50.85
(24.8 to 57.1)
40.85
(32.0 to 57.9)
45.95
(24.8 to 57.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 6 participants 16 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
10
 100.0%
6
 100.0%
16
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 6 participants 16 participants
Hispanic or Latino
3
  30.0%
2
  33.3%
5
  31.3%
Not Hispanic or Latino
7
  70.0%
4
  66.7%
11
  68.8%
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 10 participants 6 participants 16 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
4
  40.0%
4
  66.7%
8
  50.0%
White
4
  40.0%
0
   0.0%
4
  25.0%
More than one race
1
  10.0%
1
  16.7%
2
  12.5%
Unknown or Not Reported
1
  10.0%
1
  16.7%
2
  12.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 6 participants 16 participants
10 6 16
1.Primary Outcome
Title Overall Response Rate (ORR) of Six Cycles of Liposomal Doxorubicin Combined With Bevacizumab in Patients With Advanced KS.
Hide Description Overall response rate is complete response + clinical complete response + partial response. The overall response rate is the fraction of subjects with an overall response after 6 cycles of liposomal doxorubicin in combination with bevacizumab. Response was assessed by a modification of the Acquired Immune Deficiency Syndrome Clinical Trial Group Oncology Committee criteria. Complete response is the absence of any detectable residual disease, including tumor-associated edema, persisting for at least 4 weeks. Clinical complete response is the absence of any detectable residual disease, including tumor associated edema. persisting for at least 4 weeks. Partial response is no progressive disease (increase of 25% or more over baseline in the number of lesions and/or size (sum of the products of the largest perpendicular diameters of the marker lesions) & noting that single lesions which split up into 2 or more smaller lesions during the course of treatment will still be counted as 1.
Time Frame 6 cycles, an average of 18 weeks
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title KS; Classic or HIV+ Not Improved on Antivirals All Other Advanced HIV-associated Kaposi's Sarcoma (KS)
Hide Arm/Group Description:

Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.

Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.

Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles.

All other patients with advanced AIDS-associated KS

Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.

Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles.

Overall Number of Participants Analyzed 10 6
Measure Type: Number
Number (80% Confidence Interval)
Unit of Measure: percentage of participants
50
(27 to 73)
67
(33 to 91)
2.Secondary Outcome
Title Complete Response Rate After 6 Cycles of Liposomal Doxorubicin Combined With Bevacizumab
Hide Description Complete response rate is the fraction of subjects with an complete response after 6 cycles of liposomal doxorubicin in combination with bevacizumab. Response was assessed by a modification of the Acquired Immune Deficiency Syndrome Clinical Trial Group Oncology Committee criteria. Complete response is the absence of any detectable residual disease, including tumor-associated edema, persisting for at least 4 weeks. In patients whom pigmented macular skin lesions persist after apparent complete response, biopsy of at least one representative lesion is required to document the absence of malignant cells. In patients known to have had visceral disease, an attempt at restaging with appropriate endoscopic or radiographic procedures should be made. If such procedures are medically contraindicated, the patient may be classified as having a clinical complete response.
Time Frame 6 cycles, an average of 18 weeks
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Hide Analysis Population Description
No patients had a complete response.
Arm/Group Title KS; Classic or HIV+ Not Improved on Antivirals All Other Advanced HIV-associated Kaposi's Sarcoma (KS)
Hide Arm/Group Description:

Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.

Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.

Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles.

All other patients with advanced AIDS-associated KS

Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.

Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles.

Overall Number of Participants Analyzed 10 6
Measure Type: Number
Number (80% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 21)
0
(0 to 32)
3.Secondary Outcome
Title Count of Participants With Serious and Non-serious Adverse Events
Hide Description Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). 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 7 years and 6 months and 21 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title KS; Classic or HIV+ Not Improved on Antivirals All Other Advanced HIV-associated Kaposi's Sarcoma (KS)
Hide Arm/Group Description:

Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.

Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m2^ and bevacizumab every 3 weeks for six cycles.

Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles.

All other patients with advanced AIDS-associated KS

Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.

Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles.

Overall Number of Participants Analyzed 10 6
Measure Type: Count of Participants
Unit of Measure: Participants
10
 100.0%
6
 100.0%
4.Secondary Outcome
Title Median Number of Cycles Need to Obtain a Partial Response
Hide Description Response was assessed by a modification of the Acquired Immune Deficiency Syndrome Clinical Trial Group Oncology Committee criteria. Partial response is no progressive disease (increase of 25% or more over baseline in the number of lesions and/or size (sum of the products of the largest perpendicular diameters of the marker lesions) and noting that single lesions which split up into 2 or more smaller lesions during the course of treatment will still be counted as 1; no new lesions occurring in previously uninvolved areas of the body; no new visceral sites of involvement or the appearance or worsening of tumor-associated edema or effusions and a 50% or greater decrease in the number and/or size of previously existing lesions lasting for at least 4 weeks or complete flattening of at least 50% of all previously raised lesions (i.e., 50% of all previously nodular or plaque-like lesions become macular) lasting for at least 4 weeks.
Time Frame 6 cycles, an average of 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title KS; Classic or HIV+ Not Improved on Antivirals All Other Advanced HIV-associated Kaposi's Sarcoma (KS)
Hide Arm/Group Description:

Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.

Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.

Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles.

All other patients with advanced AIDS-associated KS

Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.

Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles.

Overall Number of Participants Analyzed 10 6
Median (95% Confidence Interval)
Unit of Measure: Cycles
2
(1 to 6)
4
(1 to 5)
5.Secondary Outcome
Title Percentage of Participants With 12- Month Progression-free Survival (PFS)
Hide Description Participants who survived and were progression free for 12 months. Response was assessed by a modification of the Acquired Immune Deficiency Syndrome Clinical Trial Group Oncology Committee criteria. Progressive disease is an increase of 25% or more over baseline in the number of lesions and/or size (sum of the products of the largest perpendicular diameters) of the marker lesions or a change in character from macular to plaque-like or nodular of at least 25% of the lesions or new visceral sites of involvement or progression of visceral disease or the development of new or increasing tumor-associated edema or effusion that lasts at least 1 week and interfered with the patient's normal activities.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title KS; Classic or HIV+ Not Improved on Antivirals All Other Advanced HIV-associated Kaposi's Sarcoma (KS)
Hide Arm/Group Description:

Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.

Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.

Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m2^ and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles.

All other patients with advanced AIDS-associated KS

Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.

Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles.

Overall Number of Participants Analyzed 10 6
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
44
(23 to 64)
42
(15 to 67)
Time Frame 7 years and 6 months and 21 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title KS; Classic or HIV+ Not Improved on Antivirals All Other Advanced HIV-associated Kaposi's Sarcoma (KS)
Hide Arm/Group Description

Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.

Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.

Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles.

All other patients with advanced AIDS-associated KS

Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.

Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles.

All-Cause Mortality
KS; Classic or HIV+ Not Improved on Antivirals All Other Advanced HIV-associated Kaposi's Sarcoma (KS)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)      0/6 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
KS; Classic or HIV+ Not Improved on Antivirals All Other Advanced HIV-associated Kaposi's Sarcoma (KS)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      1/6 (16.67%)    
Gastrointestinal disorders     
Hemorrhage, GI::Rectum  1  0/10 (0.00%)  0 1/6 (16.67%)  1
1
Term from vocabulary, CTCAE (3.0)
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%
KS; Classic or HIV+ Not Improved on Antivirals All Other Advanced HIV-associated Kaposi's Sarcoma (KS)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/10 (100.00%)      6/6 (100.00%)    
Blood and lymphatic system disorders     
CD4 count  1  5/10 (50.00%)  9 2/6 (33.33%)  7
Edema: limb  1  4/10 (40.00%)  8 2/6 (33.33%)  3
Leukocytes (total WBC)  1  6/10 (60.00%)  35 4/6 (66.67%)  43
Lymphopenia  1  8/10 (80.00%)  34 5/6 (83.33%)  25
Neutrophils/granulocytes (ANC/AGC)  1  5/10 (50.00%)  35 4/6 (66.67%)  42
PTT (Partial Thromboplastin Time)  1  2/10 (20.00%)  3 0/6 (0.00%)  0
Platelets  1  6/10 (60.00%)  21 1/6 (16.67%)  1
Cardiac disorders     
Hypertension  1  4/10 (40.00%)  8 1/6 (16.67%)  4
Endocrine disorders     
Hot flashes/flushes  1  0/10 (0.00%)  0 2/6 (33.33%)  2
Thyroid function, low (hypothyroidism)  1  3/10 (30.00%)  3 1/6 (16.67%)  1
Gastrointestinal disorders     
Anal bleeding  1  1/10 (10.00%)  1 0/6 (0.00%)  0
Constipation  1  2/10 (20.00%)  3 3/6 (50.00%)  3
Dental: periodontal disease  1  2/10 (20.00%)  2 0/6 (0.00%)  0
Dental: teeth  1  2/10 (20.00%)  4 1/6 (16.67%)  1
Diarrhea  1  2/10 (20.00%)  3 3/6 (50.00%)  7
Discoloration of Hard Palate  1  1/10 (10.00%)  1 0/6 (0.00%)  0
Dysphagia (difficulty swallowing)  1  1/10 (10.00%)  1 0/6 (0.00%)  0
Gastrointestinal - Heartburn/dyspepsia  1 [1]  1/10 (10.00%)  1 1/6 (16.67%)  1
Gum bleeding  1  1/10 (10.00%)  1 0/6 (0.00%)  0
Heartburn/dyspepsia  1  1/10 (10.00%)  1 0/6 (0.00%)  0
Hemorrhage, GI::Abdomen NOS  1  0/10 (0.00%)  0 1/6 (16.67%)  1
Hemorrhage, GI::Oral cavity  1  0/10 (0.00%)  0 1/6 (16.67%)  1
Hemorrhage, GU::Urinary NOS  1  1/10 (10.00%)  1 3/6 (50.00%)  6
Mucositis/stomatitis (clinical exam)::Oral cavity  1  1/10 (10.00%)  1 0/6 (0.00%)  0
Mucositis/stomatitis (clinical exam)::Stomach  1  1/10 (10.00%)  2 0/6 (0.00%)  0
Nausea  1  3/10 (30.00%)  5 2/6 (33.33%)  2
Pain::Abdomen NOS  1  0/10 (0.00%)  0 1/6 (16.67%)  1
Pain::Anus  1  1/10 (10.00%)  1 0/6 (0.00%)  0
Pain::Oral cavity  1  0/10 (0.00%)  0 1/6 (16.67%)  2
Pain::Oral-gums  1  1/10 (10.00%)  1 0/6 (0.00%)  0
Pain::Rectum  1  0/10 (0.00%)  0 1/6 (16.67%)  1
Periodontal disease  1  1/10 (10.00%)  1 0/6 (0.00%)  0
Taste alteration (dysgeusia)  1  1/10 (10.00%)  1 1/6 (16.67%)  1
Ulcer, GI::Anus  1  1/10 (10.00%)  1 0/6 (0.00%)  0
Ulcer, GI::Rectum  1  0/10 (0.00%)  0 1/6 (16.67%)  1
Vomiting  1  1/10 (10.00%)  1 1/6 (16.67%)  1
Hemorrhage/Bleeding-Hemorrhage, GI  1 [2]  1/10 (10.00%)  1 1/6 (16.67%)  1
General disorders     
Constitutional Symptoms - Other (R leg swelling)  1  0/10 (0.00%)  0 1/6 (16.67%)  1
Fatigue (asthenia, lethargy, malaise)  1  5/10 (50.00%)  12 3/6 (50.00%)  6
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)  1  1/10 (10.00%)  2 0/6 (0.00%)  0
Pain - Right posterior knee  1 [3]  0/10 (0.00%)  0 1/6 (16.67%)  1
Pain::Pain NOS  1  2/10 (20.00%)  2 1/6 (16.67%)  1
Sweating (diaphoresis)  1  0/10 (0.00%)  0 1/6 (16.67%)  1
Pain - Leg  1 [4]  0/10 (0.00%)  0 1/6 (16.67%)  1
Pain - Left foot  1 [5]  1/10 (10.00%)  1 0/6 (0.00%)  0
Pain - Left middle finger  1 [6]  0/10 (0.00%)  0 1/6 (16.67%)  1
Pain - Right foot  1 [7]  1/10 (10.00%)  1 0/6 (0.00%)  0
Pain - Thigh  1 [8]  1/10 (10.00%)  1 0/6 (0.00%)  0
Pain - Neck, back, shoulder  1 [9]  1/10 (10.00%)  2 0/6 (0.00%)  0
Immune system disorders     
Allergic reaction/hypersensitivity (including drug fever)  1  1/10 (10.00%)  1 1/6 (16.67%)  1
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)  1  2/10 (20.00%)  2 0/6 (0.00%)  0
Rhinorrhea  1  1/10 (10.00%)  1 0/6 (0.00%)  0
Runny nose  1  2/10 (20.00%)  2 0/6 (0.00%)  0
Infections and infestations     
Infection with normal ANC or Grade 1 or 2 neutrophils::Anal/perianal  1  1/10 (10.00%)  1 0/6 (0.00%)  0
Infection with normal ANC or Grade 1 or 2 neutrophils::Bronchus  1  1/10 (10.00%)  1 0/6 (0.00%)  0
Infection with normal ANC or Grade 1 or 2 neutrophils::Colon  1  0/10 (0.00%)  0 1/6 (16.67%)  1
Infection with normal ANC or Grade 1 or 2 neutrophils::Dental-tooth  1  2/10 (20.00%)  2 1/6 (16.67%)  1
Infection with normal ANC or Grade 1 or 2 neutrophils::Oral cavity-gums (gingivitis)  1  2/10 (20.00%)  2 0/6 (0.00%)  0
Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS  1  4/10 (40.00%)  5 0/6 (0.00%)  0
Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS  1  0/10 (0.00%)  0 1/6 (16.67%)  1
Infection with unknown ANC::Dental-tooth  1  0/10 (0.00%)  0 1/6 (16.67%)  2
Infection with unknown ANC::Upper airway NOS  1  2/10 (20.00%)  2 1/6 (16.67%)  1
Infection – Other, Ungual, foot  1 [10]  1/10 (10.00%)  1 1/6 (16.67%)  1
Metabolism and nutrition disorders     
ALT, SGPT (serum glutamic pyruvic transaminase)  1  7/10 (70.00%)  26 5/6 (83.33%)  17
AST, SGOT(serum glutamic oxaloacetic transaminase)  1  8/10 (80.00%)  28 5/6 (83.33%)  16
Albumin, serum-low (hypoalbuminemia)  1  4/10 (40.00%)  12 5/6 (83.33%)  38
Alkaline phosphatase  1  2/10 (20.00%)  4 3/6 (50.00%)  26
Amylase  1  1/10 (10.00%)  1 0/6 (0.00%)  0
Bicarbonate, serum-low  1  0/10 (0.00%)  0 1/6 (16.67%)  1
Bilirubin (hyperbilirubinemia)  1  1/10 (10.00%)  6 2/6 (33.33%)  26
CPK (creatine phosphokinase)  1  3/10 (30.00%)  11 5/6 (83.33%)  15
Calcium, serum-high (hypercalcemia)  1  1/10 (10.00%)  1 1/6 (16.67%)  4
Calcium, serum-low (hypocalcemia)  1  2/10 (20.00%)  3 0/6 (0.00%)  0
Cholesterol, serum-high (hypercholesteremia)  1  1/10 (10.00%)  1 2/6 (33.33%)  3
Creatinine  1  1/10 (10.00%)  1 2/6 (33.33%)  10
GGT (gamma-Glutamyl transpeptidase)  1  1/10 (10.00%)  2 0/6 (0.00%)  0
Glucose, serum-high (hyperglycemia)  1  4/10 (40.00%)  11 3/6 (50.00%)  5
Glucose, serum-low (hypoglycemia)  1  1/10 (10.00%)  1 2/6 (33.33%)  4
Hemoglobin  1  7/10 (70.00%)  21 5/6 (83.33%)  29
Hemoglobinuria  1  1/10 (10.00%)  1 0/6 (0.00%)  0
Hypercholesterolemia  1  0/10 (0.00%)  0 1/6 (16.67%)  2
Magnesium, serum-high (hypermagnesemia)  1  2/10 (20.00%)  2 3/6 (50.00%)  7
Magnesium, serum-low (hypomagnesemia)  1  5/10 (50.00%)  6 2/6 (33.33%)  2
Phosphate, serum-low (hypophosphatemia)  1  5/10 (50.00%)  20 3/6 (50.00%)  3
Potassium, serum-high (hyperkalemia)  1  2/10 (20.00%)  4 2/6 (33.33%)  2
Potassium, serum-low (hypokalemia)  1  0/10 (0.00%)  0 1/6 (16.67%)  1
Proteinuria  1  5/10 (50.00%)  13 3/6 (50.00%)  18
Sodium, serum-high (hypernatremia)  1  2/10 (20.00%)  2 2/6 (33.33%)  2
Sodium, serum-low (hyponatremia)  1  3/10 (30.00%)  3 4/6 (66.67%)  6
Triglyceride, serum-high (hypertriglyceridemia)  1  2/10 (20.00%)  2 2/6 (33.33%)  5
Uric acid, serum-high (hyperuricemia)  1  4/10 (40.00%)  8 1/6 (16.67%)  6
Metabolic/Laboratory-"Urobilinogen" t  1 [11]  0/10 (0.00%)  0 1/6 (16.67%)  4
Musculoskeletal and connective tissue disorders     
Musculoskeletal/Soft Tissue - Other (Aches/Myalgia; Muscle spasm)  1  1/10 (10.00%)  1 1/6 (16.67%)  1
Neck heaviness  1  1/10 (10.00%)  1 0/6 (0.00%)  0
Pain::Back  1  3/10 (30.00%)  3 0/6 (0.00%)  0
Pain::Bone  1  0/10 (0.00%)  0 1/6 (16.67%)  2
Pain::Extremity-limb  1  0/10 (0.00%)  0 1/6 (16.67%)  1
Pain::Joint  1  4/10 (40.00%)  5 1/6 (16.67%)  1
Pain::Muscle  1  1/10 (10.00%)  2 1/6 (16.67%)  2
Pain::Neck  1  1/10 (10.00%)  1 1/6 (16.67%)  1
Musculoskeletal/Soft Tissue, Other-fasciitis, plantar  1 [12]  1/10 (10.00%)  1 0/6 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Pain::Tumor pain  1  1/10 (10.00%)  2 0/6 (0.00%)  0
Nervous system disorders     
CNS cerebrovascular ischemia  1  1/10 (10.00%)  1 0/6 (0.00%)  0
Memory impairment  1  1/10 (10.00%)  1 0/6 (0.00%)  0
Mood alteration::Anxiety  1  1/10 (10.00%)  2 0/6 (0.00%)  0
Mood alteration::Depression  1  1/10 (10.00%)  2 0/6 (0.00%)  0
Neurology - Other (Burning smell)  1  1/10 (10.00%)  1 0/6 (0.00%)  0
Neuropathy: sensory  1  4/10 (40.00%)  4 2/6 (33.33%)  3
Pain::Head/headache  1  5/10 (50.00%)  6 1/6 (16.67%)  1
Paresthesia  1  2/10 (20.00%)  3 1/6 (16.67%)  1
Psychosis (hallucinations/delusions)  1  0/10 (0.00%)  0 1/6 (16.67%)  1
Syncope (fainting)  1  0/10 (0.00%)  0 1/6 (16.67%)  1
Renal and urinary disorders     
Hematuria  1  2/10 (20.00%)  4 0/6 (0.00%)  0
Hemorrhage, pulmonary/upper respiratory::Nose  1  3/10 (30.00%)  3 4/6 (66.67%)  17
Hemorrhage/Bleeding-Hemorrhage, GU  1 [13]  0/10 (0.00%)  0 1/6 (16.67%)  1
Urinary retention (including neurogenic bladder)  1  0/10 (0.00%)  0 1/6 (16.67%)  1
Reproductive system and breast disorders     
Pain::Urethra  1  1/10 (10.00%)  1 1/6 (16.67%)  1
Respiratory, thoracic and mediastinal disorders     
Cough  1  2/10 (20.00%)  5 2/6 (33.33%)  4
Dyspnea (shortness of breath)  1  3/10 (30.00%)  4 3/6 (50.00%)  7
Epistaxis  1  2/10 (20.00%)  3 0/6 (0.00%)  0
Nasal cavity/paranasal sinus reactions  1  1/10 (10.00%)  1 0/6 (0.00%)  0
Nasal congestion  1  1/10 (10.00%)  1 1/6 (16.67%)  1
Nasal discharge  1  1/10 (10.00%)  1 0/6 (0.00%)  0
Pain::Throat/pharynx/larynx  1  0/10 (0.00%)  0 1/6 (16.67%)  3
Upper respiratory  1  0/10 (0.00%)  0 1/6 (16.67%)  1
Pulmonary/Upper Respiratory-Nasal cavity/paranasal sinus  1 [14]  1/10 (10.00%)  1 1/6 (16.67%)  1
Skin and subcutaneous tissue disorders     
Dermatology/Skin - Skin breakdown  1 [15]  1/10 (10.00%)  1 0/6 (0.00%)  0
Dry skin  1  1/10 (10.00%)  1 1/6 (16.67%)  1
Flushing  1  2/10 (20.00%)  2 0/6 (0.00%)  0
Hyperpigmentation  1  1/10 (10.00%)  1 1/6 (16.67%)  1
Dermatology/Skin-Rash:acne/acneiform  1 [16]  1/10 (10.00%)  1 1/6 (16.67%)  1
Nail changes  1  1/10 (10.00%)  1 1/6 (16.67%)  1
Pruritus/itching  1  2/10 (20.00%)  2 0/6 (0.00%)  0
Rash/desquamation  1  3/10 (30.00%)  3 4/6 (66.67%)  9
Rash: acne/acneiform  1  1/10 (10.00%)  1 1/6 (16.67%)  1
Skin breakdown/decubitus ulcer  1  1/10 (10.00%)  1 0/6 (0.00%)  0
Ulceration  1  2/10 (20.00%)  2 0/6 (0.00%)  0
Dermatology/Skin - Rash: acne/acneform  1 [17]  1/10 (10.00%)  1 0/6 (0.00%)  0
Dermatology/Skin - Hand-foot Syndrome  1 [18]  1/10 (10.00%)  1 3/6 (50.00%)  4
Dermatology/Skin - Rash/desquamation  1 [19]  2/10 (20.00%)  2 1/6 (16.67%)  1
Dermatology/Skin - Hyperpigmentation  1 [20]  1/10 (10.00%)  1 0/6 (0.00%)  0
Dermatology/Skin - Dermal change  1 [21]  1/10 (10.00%)  1 0/6 (0.00%)  0
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
[1]
Reflux
[2]
Hematochezia
[3]
8/10
[4]
Leg
[5]
Sole of left foot
[6]
Left middle finger
[7]
Right foot pain
[8]
Thigh
[9]
Neck, back, shoulder pain
[10]
Fungal foot rash
[11]
Urobilinogen 2-3
[12]
Plantar fascilitis
[13]
Hematuria
[14]
Sinusitis
[15]
Abrasion
[16]
Folliculitis L groin
[17]
Folliculitis
[18]
Rash: hand-foot skin reaction
[19]
Maculo-papular rash; Skin desquamation sole of L foot
[20]
Skin discoloration-hands
[21]
Skin thickening
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. Robert Yarchoan
Organization: National Cancer Institute
Phone: 301-496-0328
EMail: yarchoanr@pop.nci.nih.gov
Layout table for additonal information
Responsible Party: Robert Yarchoan, National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00923936     History of Changes
Obsolete Identifiers: NCT00902239
Other Study ID Numbers: 090130
09-C-0130
First Submitted: June 17, 2009
First Posted: June 18, 2009
Results First Submitted: April 14, 2017
Results First Posted: June 16, 2017
Last Update Posted: July 24, 2018