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Comparing Three Different Combination Chemotherapy Regimens in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT00634244
Recruitment Status : Completed
First Posted : March 12, 2008
Results First Posted : July 7, 2015
Last Update Posted : July 7, 2015
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Adult Acute Monoblastic Leukemia (M5a)
Adult Acute Monocytic Leukemia (M5b)
Adult Acute Myeloblastic Leukemia With Maturation (M2)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Adult Acute Myelomonocytic Leukemia (M4)
Adult Erythroleukemia (M6a)
Adult Pure Erythroid Leukemia (M6b)
Recurrent Adult Acute Myeloid Leukemia
Interventions Drug: alvocidib
Drug: mitoxantrone hydrochloride
Drug: carboplatin
Drug: cytarabine
Drug: sirolimus
Drug: etoposide
Drug: topotecan hydrochloride
Enrollment 92
Recruitment Details This study was activated on October 16, 2008 and closed on August 2, 2013 with a total of 92 patients accrued. Duration the response evaluation after meeting the first stage accrual goal, Arm C did not meet the criteria to continue onto the second stage and was closed to accrual at that time.
Pre-assignment Details  
Arm/Group Title Arm A (Carboplatin and Topotecan Hydrochloride) Arm B (Alvocidib, Mitoxantrone Hydrochloride, Cytarabine) Arm C (Mitoxantrone Hydrochloride, Cytarabine, Sirolimus)
Hide Arm/Group Description

Patients receive carboplatin and topotecan hydrochloride IV continuously over 24 hours on days 1-5.

carboplatin: Given IV

topotecan hydrochloride: Given IV

Patients receive alvocidib IV over 4.5 hours qd on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9.

alvocidib: Given IV

mitoxantrone hydrochloride: Given IV

cytarabine: Given IV

Patients receive sirolimus PO qd on days 2-9, mitoxantrone hydrochloride IV over 15 minutes qd, etoposide IV over 1 hour qd, and cytarabine IV over 3 hours qd on days 4-8 or 5-9. (Closed to accrual)

mitoxantrone hydrochloride: Given IV

cytarabine: Given IV

sirolimus: Given PO

etoposide: Given IV

Period Title: Overall Study
Started 35 37 20
Eligible and Treated 35 36 20
Completed 34 24 20
Not Completed 1 13 0
Reason Not Completed
Never started treatment             0             1             0
Death             1             6             0
Adverse Event             0             2             0
Withdrawal by Subject             0             1             0
Physician Decision             0             1             0
Disease progression/relapse             0             1             0
Other complicating disease             0             1             0
Arm/Group Title Arm A (Carboplatin+Topotecan Hydrochloride) Arm B (Alvocidib+Cytarabine+Mitoxantrone) Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine) Total
Hide Arm/Group Description Patients receive carboplatin and topotecan hydrochloride IV continuously over 24 hours on days 1-5. Patients receive alvocidib IV over 4.5 hours qd on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients receive sirolimus PO qd on days 2-9, mitoxantrone hydrochloride IV over 15 minutes qd, etoposide IV over 1 hour qd, and cytarabine IV over 3 hours qd on days 4-8 or 5-9. (Closed to accrual) Total of all reporting groups
Overall Number of Baseline Participants 35 36 20 91
Hide Baseline Analysis Population Description
Eligible and treated patients
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 35 participants 36 participants 20 participants 91 participants
55
(23 to 67)
62
(19 to 69)
52
(22 to 68)
57
(19 to 69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 36 participants 20 participants 91 participants
Female
14
  40.0%
14
  38.9%
9
  45.0%
37
  40.7%
Male
21
  60.0%
22
  61.1%
11
  55.0%
54
  59.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 36 participants 20 participants 91 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   2.9%
1
   2.8%
2
  10.0%
4
   4.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   2.9%
4
  11.1%
2
  10.0%
7
   7.7%
White
33
  94.3%
30
  83.3%
14
  70.0%
77
  84.6%
More than one race
0
   0.0%
0
   0.0%
1
   5.0%
1
   1.1%
Unknown or Not Reported
0
   0.0%
1
   2.8%
1
   5.0%
2
   2.2%
Disease status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 35 participants 36 participants 20 participants 91 participants
< 6 months after 1st CR 9 11 6 26
6-12 mos after 1st CR 8 8 3 19
Refractory 18 17 10 45
Unknown/Missing 0 0 1 1
1.Primary Outcome
Title The Rate of Complete Remission (CR+CRi)
Hide Description CR requires: 1. peripheral blood counts: neutrophil count ≥ 1.0 x 10^9/L, platelet count ≥ 100 x 10^9/L, reduced hemoglobin concentration or hematocrit has no bearing on remission status, and leukemic blasts must not be present in the peripheral blood. 2. bone marrow aspirate and biopsy: maturation of all cell lines must be present, ≤ 5% blasts, auer rods must not be detectable. 3. extramedullary leukemia, such as central nervous system (CNS) or soft tissue involvement, must not be present. CRi requires that all criteria for complete remission be satisfied except patients can have residual neutropenia (<1 x 10^9/L) or thrombocytopenia (<100 x 10^9/L).
Time Frame Assessed every 3 months for the first 2 years and then every 6 months until relapse or death up to 3 years from registration.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated
Arm/Group Title Arm A (Carboplatin+Topotecan Hydrochloride) Arm B (Alvocidib+Cytarabine+Mitoxantrone) Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine)
Hide Arm/Group Description:
Patients receive carboplatin and topotecan hydrochloride IV continuously over 24 hours on days 1-5.
Patients receive alvocidib IV over 4.5 hours qd on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9.
Patients receive sirolimus PO qd on days 2-9, mitoxantrone hydrochloride IV over 15 minutes qd, etoposide IV over 1 hour qd, and cytarabine IV over 3 hours qd on days 4-8 or 5-9. (Closed to accrual)
Overall Number of Participants Analyzed 35 36 20
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: proportion of participants
0.143
(0.071 to 0.347)
0.278
(0.161 to 0.43)
0.15
(0.042 to 0.344)
2.Secondary Outcome
Title The Rate of Treatment Failure
Hide Description

The definition of treatment failure will include:

  • ≥ 5% leukemic blasts at the time of pre-consolidation marrow
  • Death during/following induction chemotherapy (pre-consolidation)
  • Persisting marrow hypoplasia and pancytopenia for ≥ 2 months after chemotherapy
  • CNS or extramedullary disease at the time of pre-consolidation
  • Leukemia persistence after completion of induction treatment. Leukemia persistence is defined as greater than 10% residual blasts on marrow biopsy done 5-7 days after completion of induction chemotherapy
Time Frame Assessed every 3 months for the first 2 years and then every 6 months until relapse or death up to 3 years from registration.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated
Arm/Group Title Arm A (Carboplatin+Topotecan Hydrochloride) Arm B (Alvocidib+Cytarabine+Mitoxantrone) Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine)
Hide Arm/Group Description:
Patients receive carboplatin and topotecan hydrochloride IV continuously over 24 hours on days 1-5.
Patients receive alvocidib IV over 4.5 hours qd on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9.
Patients receive sirolimus PO qd on days 2-9, mitoxantrone hydrochloride IV over 15 minutes qd, etoposide IV over 1 hour qd, and cytarabine IV over 3 hours qd on days 4-8 or 5-9. (Closed to accrual)
Overall Number of Participants Analyzed 35 36 20
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: proportion of participants
0.86
(0.72 to 0.94)
0.72
(0.57 to 0.84)
0.84
(0.64 to 0.96)
Time Frame Assessed every while on treatment and for 30 days after the end of treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm A (Carboplatin+Topotecan Hydrochloride) Arm B (Alvocidib+Cytarabine+Mitoxantrone) Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine)
Hide Arm/Group Description Patients receive carboplatin and topotecan hydrochloride IV continuously over 24 hours on days 1-5. Patients receive alvocidib IV over 4.5 hours qd on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients receive sirolimus PO qd on days 2-9, mitoxantrone hydrochloride IV over 15 minutes qd, etoposide IV over 1 hour qd, and cytarabine IV over 3 hours qd on days 4-8 or 5-9. (Closed to accrual)
All-Cause Mortality
Arm A (Carboplatin+Topotecan Hydrochloride) Arm B (Alvocidib+Cytarabine+Mitoxantrone) Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm A (Carboplatin+Topotecan Hydrochloride) Arm B (Alvocidib+Cytarabine+Mitoxantrone) Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   35/35 (100.00%)   36/36 (100.00%)   20/20 (100.00%) 
Blood and lymphatic system disorders       
Anemia  1  22/35 (62.86%)  27/36 (75.00%)  11/20 (55.00%) 
Disseminated intravascular coagulation  1  0/35 (0.00%)  1/36 (2.78%)  0/20 (0.00%) 
Febrile neutropenia  1  7/35 (20.00%)  8/36 (22.22%)  11/20 (55.00%) 
Hemolysis  1  0/35 (0.00%)  0/36 (0.00%)  1/20 (5.00%) 
Cardiac disorders       
Atrial fibrillation  1  2/35 (5.71%)  1/36 (2.78%)  0/20 (0.00%) 
Pericardial effusion  1  0/35 (0.00%)  0/36 (0.00%)  1/20 (5.00%) 
Eye disorders       
Blurred vision  1  0/35 (0.00%)  1/36 (2.78%)  0/20 (0.00%) 
Cataract  1  1/35 (2.86%)  0/36 (0.00%)  0/20 (0.00%) 
Gastrointestinal disorders       
Abdominal pain  1  1/35 (2.86%)  2/36 (5.56%)  0/20 (0.00%) 
Constipation  1  2/35 (5.71%)  0/36 (0.00%)  0/20 (0.00%) 
Diarrhea  1  2/35 (5.71%)  8/36 (22.22%)  1/20 (5.00%) 
Dysphagia  1  1/35 (2.86%)  1/36 (2.78%)  0/20 (0.00%) 
Enterocolitis  1  0/35 (0.00%)  1/36 (2.78%)  0/20 (0.00%) 
Mucositis oral  1  4/35 (11.43%)  2/36 (5.56%)  0/20 (0.00%) 
Nausea  1  3/35 (8.57%)  4/36 (11.11%)  3/20 (15.00%) 
Oral hemorrhage  1  0/35 (0.00%)  1/36 (2.78%)  0/20 (0.00%) 
Oral pain  1  0/35 (0.00%)  1/36 (2.78%)  0/20 (0.00%) 
Small intestinal obstruction  1  1/35 (2.86%)  1/36 (2.78%)  0/20 (0.00%) 
Typhlitis  1  2/35 (5.71%)  1/36 (2.78%)  0/20 (0.00%) 
Vomiting  1  2/35 (5.71%)  2/36 (5.56%)  3/20 (15.00%) 
Gastrointestinal disorders - Other  1  1/35 (2.86%)  0/36 (0.00%)  0/20 (0.00%) 
General disorders       
Death NOS  1  0/35 (0.00%)  0/36 (0.00%)  1/20 (5.00%) 
Fatigue  1  1/35 (2.86%)  5/36 (13.89%)  2/20 (10.00%) 
Multi-organ failure  1  0/35 (0.00%)  3/36 (8.33%)  0/20 (0.00%) 
Pain  1  0/35 (0.00%)  1/36 (2.78%)  0/20 (0.00%) 
Immune system disorders       
Cytokine release syndrome  1  0/35 (0.00%)  1/36 (2.78%)  1/20 (5.00%) 
Infections and infestations       
Catheter related infection  1  4/35 (11.43%)  1/36 (2.78%)  0/20 (0.00%) 
Enterocolitis infectious  1  2/35 (5.71%)  1/36 (2.78%)  1/20 (5.00%) 
Lung infection  1  1/35 (2.86%)  8/36 (22.22%)  0/20 (0.00%) 
Sepsis  1  1/35 (2.86%)  7/36 (19.44%)  0/20 (0.00%) 
Sinusitis  1  0/35 (0.00%)  1/36 (2.78%)  0/20 (0.00%) 
Skin infection  1  1/35 (2.86%)  0/36 (0.00%)  0/20 (0.00%) 
Upper respiratory infection  1  0/35 (0.00%)  1/36 (2.78%)  0/20 (0.00%) 
Infections and infestations - Other  1  2/35 (5.71%)  9/36 (25.00%)  1/20 (5.00%) 
Investigations       
Activated PTT prolonged  1  0/35 (0.00%)  1/36 (2.78%)  0/20 (0.00%) 
Alanine aminotransferase increased  1  1/35 (2.86%)  1/36 (2.78%)  0/20 (0.00%) 
Alkaline phosphatase increased  1  0/35 (0.00%)  1/36 (2.78%)  0/20 (0.00%) 
Aspartate aminotransferase increased  1  1/35 (2.86%)  2/36 (5.56%)  1/20 (5.00%) 
Blood bilirubin increased  1  2/35 (5.71%)  4/36 (11.11%)  0/20 (0.00%) 
Creatinine increased  1  1/35 (2.86%)  2/36 (5.56%)  0/20 (0.00%) 
Fibrinogen decreased  1  0/35 (0.00%)  1/36 (2.78%)  0/20 (0.00%) 
GGT increased  1  0/35 (0.00%)  0/36 (0.00%)  1/20 (5.00%) 
Lymphocyte count decreased  1  10/35 (28.57%)  16/36 (44.44%)  7/20 (35.00%) 
Neutrophil count decreased  1  34/35 (97.14%)  32/36 (88.89%)  19/20 (95.00%) 
Platelet count decreased  1  35/35 (100.00%)  36/36 (100.00%)  20/20 (100.00%) 
Weight loss  1  0/35 (0.00%)  2/36 (5.56%)  0/20 (0.00%) 
White blood cell decreased  1  35/35 (100.00%)  36/36 (100.00%)  20/20 (100.00%) 
Investigations - Other, specify  1  0/35 (0.00%)  0/36 (0.00%)  1/20 (5.00%) 
Metabolism and nutrition disorders       
Anorexia  1  1/35 (2.86%)  7/36 (19.44%)  4/20 (20.00%) 
Hyperglycemia  1  1/35 (2.86%)  7/36 (19.44%)  1/20 (5.00%) 
Hyperkalemia  1  0/35 (0.00%)  1/36 (2.78%)  0/20 (0.00%) 
Hypermagnesemia  1  0/35 (0.00%)  1/36 (2.78%)  0/20 (0.00%) 
Hypertriglyceridemia  1  0/35 (0.00%)  1/36 (2.78%)  0/20 (0.00%) 
Hypoalbuminemia  1  0/35 (0.00%)  2/36 (5.56%)  0/20 (0.00%) 
Hypocalcemia  1  1/35 (2.86%)  2/36 (5.56%)  0/20 (0.00%) 
Hypokalemia  1  8/35 (22.86%)  9/36 (25.00%)  1/20 (5.00%) 
Hyponatremia  1  4/35 (11.43%)  0/36 (0.00%)  0/20 (0.00%) 
Hypophosphatemia  1  3/35 (8.57%)  9/36 (25.00%)  2/20 (10.00%) 
Tumor lysis syndrome  1  0/35 (0.00%)  3/36 (8.33%)  0/20 (0.00%) 
Metabolism and nutrition - Other  1  0/35 (0.00%)  1/36 (2.78%)  0/20 (0.00%) 
Musculoskeletal and connective tissue disorders       
Generalized muscle weakness  1  1/35 (2.86%)  1/36 (2.78%)  0/20 (0.00%) 
Nervous system disorders       
Dysphasia  1  0/35 (0.00%)  1/36 (2.78%)  0/20 (0.00%) 
Headache  1  1/35 (2.86%)  0/36 (0.00%)  0/20 (0.00%) 
Peripheral sensory neuropathy  1  0/35 (0.00%)  1/36 (2.78%)  0/20 (0.00%) 
Syncope  1  1/35 (2.86%)  0/36 (0.00%)  0/20 (0.00%) 
Nervous system disorders - Other  1  0/35 (0.00%)  1/36 (2.78%)  0/20 (0.00%) 
Psychiatric disorders       
Insomnia  1  1/35 (2.86%)  0/36 (0.00%)  0/20 (0.00%) 
Renal and urinary disorders       
Renal and urinary disorders - Other  1  0/35 (0.00%)  1/36 (2.78%)  0/20 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Adult respiratory distress syndrome  1  0/35 (0.00%)  1/36 (2.78%)  0/20 (0.00%) 
Atelectasis  1  0/35 (0.00%)  1/36 (2.78%)  0/20 (0.00%) 
Bronchopulmonary hemorrhage  1  0/35 (0.00%)  1/36 (2.78%)  0/20 (0.00%) 
Dyspnea  1  1/35 (2.86%)  2/36 (5.56%)  0/20 (0.00%) 
Epistaxis  1  0/35 (0.00%)  0/36 (0.00%)  2/20 (10.00%) 
Hypoxia  1  0/35 (0.00%)  3/36 (8.33%)  0/20 (0.00%) 
Pharyngeal mucositis  1  0/35 (0.00%)  0/36 (0.00%)  1/20 (5.00%) 
Pharyngolaryngeal pain  1  0/35 (0.00%)  0/36 (0.00%)  1/20 (5.00%) 
Pleural effusion  1  0/35 (0.00%)  1/36 (2.78%)  0/20 (0.00%) 
Pneumonitis  1  0/35 (0.00%)  1/36 (2.78%)  0/20 (0.00%) 
Pulmonary edema  1  0/35 (0.00%)  1/36 (2.78%)  0/20 (0.00%) 
Respiratory failure  1  0/35 (0.00%)  1/36 (2.78%)  0/20 (0.00%) 
Skin and subcutaneous tissue disorders       
Rash maculo-papular  1  1/35 (2.86%)  3/36 (8.33%)  1/20 (5.00%) 
Vascular disorders       
Hypotension  1  0/35 (0.00%)  5/36 (13.89%)  0/20 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 4.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm A (Carboplatin+Topotecan Hydrochloride) Arm B (Alvocidib+Cytarabine+Mitoxantrone) Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   35/35 (100.00%)   36/36 (100.00%)   20/20 (100.00%) 
Blood and lymphatic system disorders       
Anemia  1  34/35 (97.14%)  32/36 (88.89%)  20/20 (100.00%) 
Cardiac disorders       
Sinus tachycardia  1  0/35 (0.00%)  4/36 (11.11%)  2/20 (10.00%) 
Gastrointestinal disorders       
Abdominal pain  1  3/35 (8.57%)  3/36 (8.33%)  1/20 (5.00%) 
Constipation  1  3/35 (8.57%)  6/36 (16.67%)  2/20 (10.00%) 
Diarrhea  1  21/35 (60.00%)  23/36 (63.89%)  13/20 (65.00%) 
Dry mouth  1  1/35 (2.86%)  3/36 (8.33%)  1/20 (5.00%) 
Dyspepsia  1  2/35 (5.71%)  2/36 (5.56%)  1/20 (5.00%) 
Mucositis oral  1  7/35 (20.00%)  11/36 (30.56%)  7/20 (35.00%) 
Nausea  1  18/35 (51.43%)  18/36 (50.00%)  9/20 (45.00%) 
Oral pain  1  2/35 (5.71%)  1/36 (2.78%)  0/20 (0.00%) 
Vomiting  1  10/35 (28.57%)  10/36 (27.78%)  4/20 (20.00%) 
General disorders       
Chills  1  1/35 (2.86%)  10/36 (27.78%)  4/20 (20.00%) 
Edema limbs  1  5/35 (14.29%)  8/36 (22.22%)  4/20 (20.00%) 
Fatigue  1  16/35 (45.71%)  12/36 (33.33%)  9/20 (45.00%) 
Fever  1  5/35 (14.29%)  2/36 (5.56%)  0/20 (0.00%) 
Pain  1  0/35 (0.00%)  2/36 (5.56%)  1/20 (5.00%) 
Immune system disorders       
Cytokine release syndrome  1  0/35 (0.00%)  2/36 (5.56%)  0/20 (0.00%) 
Infections and infestations       
Infections and infestations - Other  1  0/35 (0.00%)  3/36 (8.33%)  0/20 (0.00%) 
Investigations       
Alanine aminotransferase increased  1  14/35 (40.00%)  12/36 (33.33%)  4/20 (20.00%) 
Alkaline phosphatase increased  1  12/35 (34.29%)  14/36 (38.89%)  8/20 (40.00%) 
Aspartate aminotransferase increased  1  15/35 (42.86%)  16/36 (44.44%)  5/20 (25.00%) 
Blood bilirubin increased  1  2/35 (5.71%)  14/36 (38.89%)  4/20 (20.00%) 
Creatinine increased  1  4/35 (11.43%)  9/36 (25.00%)  2/20 (10.00%) 
ECG QT corrected interval prolonged  1  1/35 (2.86%)  2/36 (5.56%)  0/20 (0.00%) 
INR increased  1  0/35 (0.00%)  2/36 (5.56%)  1/20 (5.00%) 
Lymphocyte count decreased  1  3/35 (8.57%)  0/36 (0.00%)  0/20 (0.00%) 
Neutrophil count decreased  1  18/35 (51.43%)  13/36 (36.11%)  12/20 (60.00%) 
Platelet count decreased  1  26/35 (74.29%)  24/36 (66.67%)  17/20 (85.00%) 
Weight loss  1  3/35 (8.57%)  3/36 (8.33%)  2/20 (10.00%) 
White blood cell decreased  1  24/35 (68.57%)  18/36 (50.00%)  16/20 (80.00%) 
Investigations - Other, specify  1  1/35 (2.86%)  2/36 (5.56%)  0/20 (0.00%) 
Metabolism and nutrition disorders       
Anorexia  1  12/35 (34.29%)  8/36 (22.22%)  6/20 (30.00%) 
Hyperglycemia  1  10/35 (28.57%)  14/36 (38.89%)  8/20 (40.00%) 
Hyperkalemia  1  2/35 (5.71%)  0/36 (0.00%)  0/20 (0.00%) 
Hypernatremia  1  2/35 (5.71%)  3/36 (8.33%)  0/20 (0.00%) 
Hyperuricemia  1  0/35 (0.00%)  3/36 (8.33%)  0/20 (0.00%) 
Hypoalbuminemia  1  9/35 (25.71%)  11/36 (30.56%)  3/20 (15.00%) 
Hypocalcemia  1  9/35 (25.71%)  10/36 (27.78%)  5/20 (25.00%) 
Hypokalemia  1  4/35 (11.43%)  9/36 (25.00%)  5/20 (25.00%) 
Hypomagnesemia  1  2/35 (5.71%)  7/36 (19.44%)  4/20 (20.00%) 
Hyponatremia  1  6/35 (17.14%)  6/36 (16.67%)  2/20 (10.00%) 
Hypophosphatemia  1  4/35 (11.43%)  5/36 (13.89%)  4/20 (20.00%) 
Metabolism and nutrition - Other  1  4/35 (11.43%)  3/36 (8.33%)  1/20 (5.00%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  0/35 (0.00%)  0/36 (0.00%)  2/20 (10.00%) 
Myalgia  1  1/35 (2.86%)  2/36 (5.56%)  1/20 (5.00%) 
Pain in extremity  1  1/35 (2.86%)  1/36 (2.78%)  2/20 (10.00%) 
Nervous system disorders       
Dizziness  1  0/35 (0.00%)  3/36 (8.33%)  1/20 (5.00%) 
Dysgeusia  1  3/35 (8.57%)  4/36 (11.11%)  3/20 (15.00%) 
Headache  1  5/35 (14.29%)  5/36 (13.89%)  3/20 (15.00%) 
Peripheral sensory neuropathy  1  3/35 (8.57%)  1/36 (2.78%)  0/20 (0.00%) 
Psychiatric disorders       
Insomnia  1  3/35 (8.57%)  4/36 (11.11%)  2/20 (10.00%) 
Renal and urinary disorders       
Urinary frequency  1  1/35 (2.86%)  2/36 (5.56%)  0/20 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Allergic rhinitis  1  3/35 (8.57%)  0/36 (0.00%)  0/20 (0.00%) 
Cough  1  0/35 (0.00%)  3/36 (8.33%)  2/20 (10.00%) 
Dyspnea  1  1/35 (2.86%)  6/36 (16.67%)  0/20 (0.00%) 
Epistaxis  1  3/35 (8.57%)  3/36 (8.33%)  0/20 (0.00%) 
Hypoxia  1  0/35 (0.00%)  2/36 (5.56%)  0/20 (0.00%) 
Productive cough  1  0/35 (0.00%)  2/36 (5.56%)  0/20 (0.00%) 
Sore throat  1  0/35 (0.00%)  2/36 (5.56%)  1/20 (5.00%) 
Skin and subcutaneous tissue disorders       
Alopecia  1  4/35 (11.43%)  6/36 (16.67%)  2/20 (10.00%) 
Erythema multiforme  1  2/35 (5.71%)  1/36 (2.78%)  0/20 (0.00%) 
Hyperhidrosis  1  0/35 (0.00%)  3/36 (8.33%)  0/20 (0.00%) 
Pruritus  1  0/35 (0.00%)  3/36 (8.33%)  3/20 (15.00%) 
Rash maculo-papular  1  4/35 (11.43%)  9/36 (25.00%)  4/20 (20.00%) 
Vascular disorders       
Hematoma  1  1/35 (2.86%)  2/36 (5.56%)  0/20 (0.00%) 
Hypertension  1  2/35 (5.71%)  0/36 (0.00%)  0/20 (0.00%) 
Hypotension  1  9/35 (25.71%)  6/36 (16.67%)  4/20 (20.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 4.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Study Statistician
Organization: ECOG Statistical Office
Phone: 617-632-3012
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00634244     History of Changes
Other Study ID Numbers: NCI-2009-00520
NCI-2009-00520 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
E1906 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
U10CA021115 ( U.S. NIH Grant/Contract )
First Submitted: March 11, 2008
First Posted: March 12, 2008
Results First Submitted: June 10, 2015
Results First Posted: July 7, 2015
Last Update Posted: July 7, 2015