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Vorinostat, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

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: NCT00731731
Recruitment Status : Active, not recruiting
First Posted : August 11, 2008
Results First Posted : May 13, 2015
Last Update Posted : December 23, 2019
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adult Giant Cell Glioblastoma
Adult Glioblastoma
Adult Gliosarcoma
Interventions Radiation: 3-Dimensional Conformal Radiation Therapy
Procedure: Cognitive Assessment
Other: Laboratory Biomarker Analysis
Drug: Temozolomide
Drug: Vorinostat
Enrollment 125
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Phase I, Dose Level 0 Phase I, Dose Level 1 Phase II
Hide Arm/Group Description

Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD (every day) on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

  • dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies

Patients undergo 60 Gy radiotherapy and receive 400 mg vorinostat PO QD (every day) on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

  • dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies

Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD (every day) on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 400 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5 for cycle 2 and 200 mg/m2 temozolomide PO QD on days 1-5 for all subsequent cycles. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

  • dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies
Period Title: Overall Study
Started 12 3 110
Completed 12 3 107
Not Completed 0 0 3
Reason Not Completed
Protocol Violation             0             0             1
Cancel prior to treatment             0             0             2
Arm/Group Title Phase I, Dose Level 0 Phase I, Dose Level 1 Phase II Total
Hide Arm/Group Description

Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. >

  • dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies

Patients undergo 60 Gy radiotherapy and receive 400 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. >

  • dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies

Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 400 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5 for cycle 2 and 200 mg/m2 temozolomide PO QD on days 1-5 for all subsequent cycles. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. >

  • dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies
Total of all reporting groups
Overall Number of Baseline Participants 12 3 107 122
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 12 participants 3 participants 107 participants 122 participants
57
(43 to 76)
59
(58 to 73)
59
(20 to 80)
59
(20 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 3 participants 107 participants 122 participants
Female
4
  33.3%
3
 100.0%
44
  41.1%
51
  41.8%
Male
8
  66.7%
0
   0.0%
63
  58.9%
71
  58.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 3 participants 107 participants 122 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
1
   0.9%
1
   0.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
4
   3.7%
4
   3.3%
White
12
 100.0%
3
 100.0%
99
  92.5%
114
  93.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
3
   2.8%
3
   2.5%
1.Primary Outcome
Title Maximum Tolerated Dose of Vorinostat, Defined as the Dose at Which Fewer Than One-third of Patients Experience DLTs, Graded According to NCI CTCAE (Common Toxicity Criteria for Adverse Effects) Version 3.0 (Phase I)
Hide Description

The Maximum Tolerated Dose (MTD) will be based on the assessment of Dose Limiting Toxicity (DLT) during the first 10 weeks of treatment only, and will be defined as the dose at which fewer than one-third of patients experience a DLT to vorinostat. The MTD is the dose level at which 0/3 or 1/6 patients experience DLT with the next higher dose having at least 2/3 or 2/6 patients encountering DLT.

>

>

DLT will be defined as any of the following events occurring during treatment with vorinostat and temozolomide and attributable to one or both study drugs:

  • Grade 3 or 4 thrombocytopenia, grade 4 anemia or grade 4 neutropenia lasting > 7 days
  • Any non-hematologic grade 3 or greater adverse event, excluding alopecia and venous thromboembolism
  • Grade 4 radiation-induced skin changes
  • Failure to recover from toxicities to be eligible for re-treatment with vorinostat and temozolomide ≤ 14 days of the last dose of the two drugs
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase I, Dose Level 0 Phase I, Dose Level 1
Hide Arm/Group Description:

Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

  • dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies

Patients undergo 60 Gy radiotherapy and receive 400 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

  • dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies
Overall Number of Participants Analyzed 12 3
Measure Type: Number
Unit of Measure: number of patients with DLT
3 3
2.Primary Outcome
Title Overall Survival at 15 Months (Phase II)
Hide Description The primary endpoint will be survival status at 15 months (OS15). In addition, survival will be estimated using a Kaplan-Meier curve. For this analysis, patients who are still alive at the time of analysis have survival time censored at the last contact date.
Time Frame Time from study registration to the date of death from any cause, assessed up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase II
Hide Arm/Group Description:

Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 400 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5 for cycle 2 and 200 mg/m2 temozolomide PO QD on days 1-5 for all subsequent cycles. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

  • dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies
Overall Number of Participants Analyzed 107
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of phase II patients
54.6
(45.9 to 65.0)
3.Secondary Outcome
Title Incidence of Adverse Events, Based on CTC (Common Toxicity Criteria) Severity Grade
Hide Description Safety variables will be summarized by descriptive statistics. Adverse Events (AEs) that occur will be reported for each phase and dose level and described in terms of incidence and severity. Parameters will be described based on the CTC severity grading. Distribution by CTC severity grade and clinical relevance will be given.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase I, Dose Level 0 Phase I, Dose Level 1 Phase II
Hide Arm/Group Description:

Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

  • dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies

Patients undergo 60 Gy radiotherapy and receive 400 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

  • dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies

Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 400 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5 for cycle 2 and 200 mg/m2 temozolomide PO QD on days 1-5 for all subsequent cycles. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

  • dimensional conformal radiation therapy: Undergo radiotherapy > > temozolomide: Given PO > > vorinostat: Given PO > > cognitive assessment: Ancillary studies > > laboratory biomarker analysis: Correlative studies
Overall Number of Participants Analyzed 12 3 107
Measure Type: Number
Unit of Measure: participants evaluable for toxicity
12 3 107
4.Secondary Outcome
Title Time to Tumor Progression (Phase II)
Hide Description Progression free survival time will be defined from date of registration to date of progression or death.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase II
Hide Arm/Group Description:

Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 400 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5 for cycle 2 and 200 mg/m2 temozolomide PO QD on days 1-5 for all subsequent cycles. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

  • dimensional conformal radiation therapy: Undergo radiotherapy

    >

    > temozolomide: Given PO

    >

    > vorinostat: Given PO

    >

    > cognitive assessment: Ancillary studies

    >

    > laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 107
Median (95% Confidence Interval)
Unit of Measure: months
8.05
(6.21 to 9.30)
5.Secondary Outcome
Title Incidence of Adverse Events, as Per NCI CTCAE Version 3.0 (Phase II)
Hide Description The maximum grade for each type of treatment-related adverse event will be recorded for each patient, and frequency tables for each arm will be reviewed to determine patterns. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either "unrelated" or "unlikely to be related" to study treatment in the event of an actual relationship developing.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase I, Dose Level 0 Phase I, Dose Level 1 Phase II
Hide Arm/Group Description:

Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

  • dimensional conformal radiation therapy: Undergo radiotherapy

    >

    > temozolomide: Given PO

    >

    > vorinostat: Given PO

    >

    > cognitive assessment: Ancillary studies

    >

    > laboratory biomarker analysis: Correlative studies

Patients undergo 60 Gy radiotherapy and receive 400 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 500 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

  • dimensional conformal radiation therapy: Undergo radiotherapy

    >

    > temozolomide: Given PO

    >

    > vorinostat: Given PO

    >

    > cognitive assessment: Ancillary studies

    >

    > laboratory biomarker analysis: Correlative studies

Patients undergo 60 Gy radiotherapy and receive 300 mg vorinostat PO QD on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Patients also receive 75 mg/m2 temozolomide PO QD on days 1-42. Beginning 4-6 weeks later, patients receive 400 mg vorinostat PO QD on days 1-7 and 15-21 and 150 mg/m2 temozolomide PO QD on days 1-5 for cycle 2 and 200 mg/m2 temozolomide PO QD on days 1-5 for all subsequent cycles. Treatment with vorinostat and temozolomide repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

  • dimensional conformal radiation therapy: Undergo radiotherapy

    >

    > temozolomide: Given PO

    >

    > vorinostat: Given PO

    >

    > cognitive assessment: Ancillary studies

    >

    > laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 12 3 107
Measure Type: Number
Unit of Measure: participants evaluable for toxicity
12 3 107
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phase I, Dose Level 0 Phase I, Dose Level 1 Phase II
Hide Arm/Group Description laboratory biomarker analysis: Correlative studies laboratory biomarker analysis: Correlative studies laboratory biomarker analysis: Correlative studies
All-Cause Mortality
Phase I, Dose Level 0 Phase I, Dose Level 1 Phase II
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Phase I, Dose Level 0 Phase I, Dose Level 1 Phase II
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/12 (91.67%)      1/3 (33.33%)      63/107 (58.88%)    
Blood and lymphatic system disorders       
Blood disorder  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  4
Febrile neutropenia  1  1/12 (8.33%)  1 0/3 (0.00%)  0 1/107 (0.93%)  1
Hemoglobin decreased  1  1/12 (8.33%)  1 1/3 (33.33%)  1 11/107 (10.28%)  26
Cardiac disorders       
Atrial tachycardia  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Gastrointestinal disorders       
Abdominal pain  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Colitis  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Colonic perforation  1  0/12 (0.00%)  0 0/3 (0.00%)  0 2/107 (1.87%)  2
Diarrhea  1  0/12 (0.00%)  0 0/3 (0.00%)  0 3/107 (2.80%)  6
Ear, nose and throat examination abnormal  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Gastritis  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Nausea  1  1/12 (8.33%)  1 0/3 (0.00%)  0 1/107 (0.93%)  2
Vomiting  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
General disorders       
Edema limbs  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  3
Fatigue  1  0/12 (0.00%)  0 1/3 (33.33%)  1 10/107 (9.35%)  17
Flu-like symptoms  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
General symptom  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Localized edema  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Infections and infestations       
Infection  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Opportunistic infection  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Sepsis  1  0/12 (0.00%)  0 0/3 (0.00%)  0 2/107 (1.87%)  2
Skin infection  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Upper respiratory infection  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Injury, poisoning and procedural complications       
Aortic injury  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Fracture  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Intraoperative neurological injury  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Vascular access complication  1  0/12 (0.00%)  0 0/3 (0.00%)  0 4/107 (3.74%)  7
Investigations       
Alanine aminotransferase increased  1  0/12 (0.00%)  0 0/3 (0.00%)  0 8/107 (7.48%)  13
Alkaline phosphatase increased  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Aspartate aminotransferase increased  1  0/12 (0.00%)  0 0/3 (0.00%)  0 5/107 (4.67%)  6
Bilirubin increased  1  0/12 (0.00%)  0 0/3 (0.00%)  0 2/107 (1.87%)  4
Creatinine increased  1  0/12 (0.00%)  0 0/3 (0.00%)  0 2/107 (1.87%)  3
Gamma-glutamyltransferase increased  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Laboratory test abnormal  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Leukocyte count decreased  1  1/12 (8.33%)  1 1/3 (33.33%)  1 19/107 (17.76%)  54
Lipase increased  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Lymphocyte count decreased  1  4/12 (33.33%)  4 0/3 (0.00%)  0 18/107 (16.82%)  61
Neutrophil count decreased  1  1/12 (8.33%)  1 1/3 (33.33%)  1 17/107 (15.89%)  47
Platelet count decreased  1  4/12 (33.33%)  4 1/3 (33.33%)  1 25/107 (23.36%)  81
Weight loss  1  0/12 (0.00%)  0 0/3 (0.00%)  0 3/107 (2.80%)  11
Metabolism and nutrition disorders       
Anorexia  1  0/12 (0.00%)  0 1/3 (33.33%)  1 5/107 (4.67%)  14
Blood glucose increased  1  1/12 (8.33%)  1 0/3 (0.00%)  0 1/107 (0.93%)  1
Dehydration  1  0/12 (0.00%)  0 1/3 (33.33%)  1 5/107 (4.67%)  11
Serum albumin decreased  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Serum calcium decreased  1  0/12 (0.00%)  0 0/3 (0.00%)  0 2/107 (1.87%)  3
Serum phosphate decreased  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Serum potassium decreased  1  0/12 (0.00%)  0 0/3 (0.00%)  0 2/107 (1.87%)  2
Serum sodium decreased  1  0/12 (0.00%)  0 1/3 (33.33%)  1 1/107 (0.93%)  4
Musculoskeletal and connective tissue disorders       
Back pain  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Muscle weakness  1  0/12 (0.00%)  0 0/3 (0.00%)  0 3/107 (2.80%)  4
Muscle weakness left-sided  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Muscle weakness lower limb  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Muscle weakness right-sided  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  2
Musculoskeletal disorder  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Nervous system disorders       
Cognitive disturbance  1  0/12 (0.00%)  0 0/3 (0.00%)  0 2/107 (1.87%)  2
Depressed level of consciousness  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Dizziness  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Hydrocephalus  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Neurological disorder NOS  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Peripheral motor neuropathy  1  0/12 (0.00%)  0 0/3 (0.00%)  0 3/107 (2.80%)  3
Seizure  1  0/12 (0.00%)  0 0/3 (0.00%)  0 3/107 (2.80%)  3
Taste alteration  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Psychiatric disorders       
Confusion  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Depression  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Personality change  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Psychosis  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Respiratory, thoracic and mediastinal disorders       
Dyspnea  1  1/12 (8.33%)  1 0/3 (0.00%)  0 0/107 (0.00%)  0
Hypoxia  1  0/12 (0.00%)  0 0/3 (0.00%)  0 2/107 (1.87%)  2
Respiratory disorder  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Skin and subcutaneous tissue disorders       
Alopecia  1  3/12 (25.00%)  3 0/3 (0.00%)  0 3/107 (2.80%)  8
Skin disorder  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Vascular disorders       
Hypotension  1  0/12 (0.00%)  0 0/3 (0.00%)  0 4/107 (3.74%)  4
Thrombosis  1  1/12 (8.33%)  1 0/3 (0.00%)  0 16/107 (14.95%)  39
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Phase I, Dose Level 0 Phase I, Dose Level 1 Phase II
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/12 (100.00%)      3/3 (100.00%)      106/107 (99.07%)    
Blood and lymphatic system disorders       
Blood disorder  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  4
Hemoglobin decreased  1  9/12 (75.00%)  28 1/3 (33.33%)  1 91/107 (85.05%)  704
Ear and labyrinth disorders       
Ear disorder  1  0/12 (0.00%)  0 0/3 (0.00%)  0 3/107 (2.80%)  7
External ear pain  1  0/12 (0.00%)  0 0/3 (0.00%)  0 2/107 (1.87%)  2
Hearing loss  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Tinnitus  1  0/12 (0.00%)  0 0/3 (0.00%)  0 2/107 (1.87%)  16
Endocrine disorders       
Hypothyroidism  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Eye disorders       
Conjunctival disorder  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Dry eye syndrome  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Eye disorder  1  0/12 (0.00%)  0 0/3 (0.00%)  0 4/107 (3.74%)  5
Flashing vision  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Vision blurred  1  0/12 (0.00%)  0 0/3 (0.00%)  0 7/107 (6.54%)  22
Watering eyes  1  0/12 (0.00%)  0 0/3 (0.00%)  0 3/107 (2.80%)  16
Gastrointestinal disorders       
Abdominal distension  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Abdominal pain  1  0/12 (0.00%)  0 0/3 (0.00%)  0 13/107 (12.15%)  28
Constipation  1  0/12 (0.00%)  0 2/3 (66.67%)  2 40/107 (37.38%)  171
Diarrhea  1  4/12 (33.33%)  6 0/3 (0.00%)  0 37/107 (34.58%)  119
Dry mouth  1  0/12 (0.00%)  0 0/3 (0.00%)  0 11/107 (10.28%)  34
Dyspepsia  1  0/12 (0.00%)  0 0/3 (0.00%)  0 8/107 (7.48%)  24
Dysphagia  1  0/12 (0.00%)  0 0/3 (0.00%)  0 2/107 (1.87%)  5
Ear, nose and throat examination abnormal  1  0/12 (0.00%)  0 0/3 (0.00%)  0 2/107 (1.87%)  6
Fecal incontinence  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Gastritis  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Gastrointestinal disorder  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  5
Hemorrhoids  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  2
Mucositis oral  1  0/12 (0.00%)  0 0/3 (0.00%)  0 8/107 (7.48%)  13
Nausea  1  6/12 (50.00%)  25 1/3 (33.33%)  1 70/107 (65.42%)  386
Oral pain  1  0/12 (0.00%)  0 0/3 (0.00%)  0 2/107 (1.87%)  3
Vomiting  1  5/12 (41.67%)  10 1/3 (33.33%)  1 38/107 (35.51%)  92
General disorders       
Chills  1  0/12 (0.00%)  0 0/3 (0.00%)  0 5/107 (4.67%)  6
Edema limbs  1  0/12 (0.00%)  0 0/3 (0.00%)  0 7/107 (6.54%)  13
Fatigue  1  12/12 (100.00%)  53 2/3 (66.67%)  2 103/107 (96.26%)  942
Fever  1  0/12 (0.00%)  0 0/3 (0.00%)  0 2/107 (1.87%)  2
Gait abnormal  1  0/12 (0.00%)  0 0/3 (0.00%)  0 8/107 (7.48%)  36
Localized edema  1  0/12 (0.00%)  0 0/3 (0.00%)  0 2/107 (1.87%)  4
Infections and infestations       
Conjunctivitis infective  1  1/12 (8.33%)  1 0/3 (0.00%)  0 0/107 (0.00%)  0
Mucosal infection  1  0/12 (0.00%)  0 0/3 (0.00%)  0 2/107 (1.87%)  7
Otitis media  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  2
Peripheral nerve infection  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Sinusitis  1  0/12 (0.00%)  0 0/3 (0.00%)  0 3/107 (2.80%)  5
Upper aerodigestive tract infection  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Upper respiratory infection  1  0/12 (0.00%)  0 0/3 (0.00%)  0 2/107 (1.87%)  2
Urinary tract infection  1  0/12 (0.00%)  0 0/3 (0.00%)  0 4/107 (3.74%)  5
Vaginal infection  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Injury, poisoning and procedural complications       
Bruising  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Dermatitis radiation  1  2/12 (16.67%)  2 0/3 (0.00%)  0 9/107 (8.41%)  19
Radiation recall reaction (dermatologic)  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Vascular access complication  1  0/12 (0.00%)  0 0/3 (0.00%)  0 2/107 (1.87%)  10
Wound dehiscence  1  0/12 (0.00%)  0 1/3 (33.33%)  1 0/107 (0.00%)  0
Investigations       
Alanine aminotransferase increased  1  4/12 (33.33%)  4 2/3 (66.67%)  2 31/107 (28.97%)  69
Alkaline phosphatase increased  1  0/12 (0.00%)  0 0/3 (0.00%)  0 6/107 (5.61%)  7
Aspartate aminotransferase increased  1  0/12 (0.00%)  0 1/3 (33.33%)  1 25/107 (23.36%)  53
Bilirubin increased  1  0/12 (0.00%)  0 0/3 (0.00%)  0 13/107 (12.15%)  51
Creatinine increased  1  3/12 (25.00%)  12 0/3 (0.00%)  0 14/107 (13.08%)  56
INR increased  1  0/12 (0.00%)  0 1/3 (33.33%)  1 1/107 (0.93%)  4
Laboratory test abnormal  1  0/12 (0.00%)  0 1/3 (33.33%)  1 1/107 (0.93%)  1
Leukocyte count decreased  1  9/12 (75.00%)  30 0/3 (0.00%)  0 65/107 (60.75%)  358
Lymphocyte count decreased  1  7/12 (58.33%)  27 2/3 (66.67%)  2 51/107 (47.66%)  256
Neutrophil count decreased  1  6/12 (50.00%)  14 0/3 (0.00%)  0 50/107 (46.73%)  198
Platelet count decreased  1  8/12 (66.67%)  44 2/3 (66.67%)  2 91/107 (85.05%)  584
Serum cholesterol increased  1  0/12 (0.00%)  0 0/3 (0.00%)  0 2/107 (1.87%)  2
Weight gain  1  0/12 (0.00%)  0 0/3 (0.00%)  0 3/107 (2.80%)  8
Weight loss  1  1/12 (8.33%)  1 0/3 (0.00%)  0 17/107 (15.89%)  53
Metabolism and nutrition disorders       
Anorexia  1  5/12 (41.67%)  17 2/3 (66.67%)  2 62/107 (57.94%)  274
Blood bicarbonate decreased  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  2
Blood glucose increased  1  1/12 (8.33%)  3 3/3 (100.00%)  3 14/107 (13.08%)  41
Dehydration  1  3/12 (25.00%)  3 1/3 (33.33%)  1 23/107 (21.50%)  32
Serum albumin decreased  1  0/12 (0.00%)  0 1/3 (33.33%)  1 5/107 (4.67%)  9
Serum calcium decreased  1  3/12 (25.00%)  6 1/3 (33.33%)  1 12/107 (11.21%)  20
Serum calcium increased  1  0/12 (0.00%)  0 0/3 (0.00%)  0 2/107 (1.87%)  8
Serum magnesium decreased  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Serum magnesium increased  1  0/12 (0.00%)  0 0/3 (0.00%)  0 2/107 (1.87%)  2
Serum phosphate decreased  1  1/12 (8.33%)  4 1/3 (33.33%)  1 9/107 (8.41%)  15
Serum potassium decreased  1  1/12 (8.33%)  1 1/3 (33.33%)  1 14/107 (13.08%)  26
Serum potassium increased  1  0/12 (0.00%)  0 1/3 (33.33%)  1 3/107 (2.80%)  4
Serum sodium decreased  1  4/12 (33.33%)  4 1/3 (33.33%)  1 13/107 (12.15%)  25
Serum sodium increased  1  0/12 (0.00%)  0 0/3 (0.00%)  0 4/107 (3.74%)  5
Serum triglycerides increased  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Musculoskeletal and connective tissue disorders       
Arthritis  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  3
Back pain  1  0/12 (0.00%)  0 0/3 (0.00%)  0 3/107 (2.80%)  7
Chest wall pain  1  0/12 (0.00%)  0 0/3 (0.00%)  0 3/107 (2.80%)  4
Joint pain  1  0/12 (0.00%)  0 0/3 (0.00%)  0 2/107 (1.87%)  2
Muscle weakness  1  0/12 (0.00%)  0 0/3 (0.00%)  0 9/107 (8.41%)  17
Muscle weakness left-sided  1  0/12 (0.00%)  0 0/3 (0.00%)  0 4/107 (3.74%)  25
Muscle weakness lower limb  1  0/12 (0.00%)  0 0/3 (0.00%)  0 8/107 (7.48%)  30
Muscle weakness upper limb  1  0/12 (0.00%)  0 0/3 (0.00%)  0 4/107 (3.74%)  12
Musculoskeletal disorder  1  0/12 (0.00%)  0 0/3 (0.00%)  0 3/107 (2.80%)  3
Myalgia  1  0/12 (0.00%)  0 0/3 (0.00%)  0 2/107 (1.87%)  3
Pain in extremity  1  0/12 (0.00%)  0 0/3 (0.00%)  0 6/107 (5.61%)  19
Soft tissue necrosis upper limb  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  4
Upper extremity dysfunction  1  0/12 (0.00%)  0 0/3 (0.00%)  0 2/107 (1.87%)  6
Nervous system disorders       
Acoustic nerve disorder NOS  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Ataxia  1  1/12 (8.33%)  1 0/3 (0.00%)  0 1/107 (0.93%)  1
Central nervous system necrosis  1  0/12 (0.00%)  0 0/3 (0.00%)  0 4/107 (3.74%)  16
Cognitive disturbance  1  4/12 (33.33%)  11 0/3 (0.00%)  0 35/107 (32.71%)  194
Depressed level of consciousness  1  0/12 (0.00%)  0 0/3 (0.00%)  0 2/107 (1.87%)  2
Dizziness  1  0/12 (0.00%)  0 0/3 (0.00%)  0 7/107 (6.54%)  28
Headache  1  1/12 (8.33%)  1 0/3 (0.00%)  0 24/107 (22.43%)  86
Intracranial hemorrhage  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Memory impairment  1  6/12 (50.00%)  14 1/3 (33.33%)  1 44/107 (41.12%)  289
Neurological disorder NOS  1  0/12 (0.00%)  0 0/3 (0.00%)  0 5/107 (4.67%)  33
Oculomotor nerve disorder  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  5
Peripheral sensory neuropathy  1  0/12 (0.00%)  0 0/3 (0.00%)  0 7/107 (6.54%)  27
Seizure  1  1/12 (8.33%)  1 0/3 (0.00%)  0 6/107 (5.61%)  6
Speech disorder  1  0/12 (0.00%)  0 0/3 (0.00%)  0 8/107 (7.48%)  28
Taste alteration  1  6/12 (50.00%)  24 1/3 (33.33%)  1 53/107 (49.53%)  283
Tremor  1  0/12 (0.00%)  0 0/3 (0.00%)  0 8/107 (7.48%)  20
Psychiatric disorders       
Agitation  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Anxiety  1  1/12 (8.33%)  1 0/3 (0.00%)  0 5/107 (4.67%)  6
Confusion  1  0/12 (0.00%)  0 0/3 (0.00%)  0 5/107 (4.67%)  9
Depression  1  0/12 (0.00%)  0 0/3 (0.00%)  0 8/107 (7.48%)  19
Insomnia  1  0/12 (0.00%)  0 0/3 (0.00%)  0 17/107 (15.89%)  46
Personality change  1  0/12 (0.00%)  0 0/3 (0.00%)  0 3/107 (2.80%)  5
Renal and urinary disorders       
Cystitis  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Hemorrhage urinary tract  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  2
Protein urine positive  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  2
Urinary frequency  1  0/12 (0.00%)  0 0/3 (0.00%)  0 3/107 (2.80%)  4
Urinary incontinence  1  0/12 (0.00%)  0 0/3 (0.00%)  0 5/107 (4.67%)  11
Urinary retention  1  0/12 (0.00%)  0 0/3 (0.00%)  0 2/107 (1.87%)  2
Urogenital disorder  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  4
Respiratory, thoracic and mediastinal disorders       
Allergic rhinitis  1  0/12 (0.00%)  0 1/3 (33.33%)  1 0/107 (0.00%)  0
Bronchospasm  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Cough  1  0/12 (0.00%)  0 1/3 (33.33%)  1 9/107 (8.41%)  11
Dyspnea  1  0/12 (0.00%)  0 0/3 (0.00%)  0 10/107 (9.35%)  15
Hemorrhage nasal  1  0/12 (0.00%)  0 0/3 (0.00%)  0 2/107 (1.87%)  2
Nasal congestion  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Pharyngolaryngeal pain  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Respiratory disorder  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  2
Voice alteration  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Skin and subcutaneous tissue disorders       
Alopecia  1  5/12 (41.67%)  8 0/3 (0.00%)  0 33/107 (30.84%)  138
Dry skin  1  0/12 (0.00%)  0 0/3 (0.00%)  0 3/107 (2.80%)  10
Erythema multiforme  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Hand-and-foot syndrome  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Nail disorder  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Petechiae  1  0/12 (0.00%)  0 0/3 (0.00%)  0 2/107 (1.87%)  5
Pruritus  1  0/12 (0.00%)  0 0/3 (0.00%)  0 4/107 (3.74%)  16
Rash acneiform  1  0/12 (0.00%)  0 0/3 (0.00%)  0 3/107 (2.80%)  8
Rash desquamating  1  0/12 (0.00%)  0 0/3 (0.00%)  0 3/107 (2.80%)  4
Skin disorder  1  0/12 (0.00%)  0 0/3 (0.00%)  0 2/107 (1.87%)  3
Skin hyperpigmentation  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  6
Skin ulceration  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  3
Sweating  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Vascular disorders       
Flushing  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Hematoma  1  0/12 (0.00%)  0 0/3 (0.00%)  0 1/107 (0.93%)  1
Hypertension  1  0/12 (0.00%)  0 0/3 (0.00%)  0 5/107 (4.67%)  29
Hypotension  1  0/12 (0.00%)  0 0/3 (0.00%)  0 3/107 (2.80%)  3
Thrombosis  1  0/12 (0.00%)  0 1/3 (33.33%)  1 5/107 (4.67%)  8
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
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
Layout table for Results Point of Contact information
Name/Title: Evanthia Galanis, M.D.
Organization: Mayo Clinic
EMail: galanis.evanthia@mayo.edu
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00731731    
Other Study ID Numbers: NCI-2009-00672
NCI-2009-00672 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
N0874
ABTC 0902
CDR0000609743
N0874 ( Other Identifier: Alliance for Clinical Trials in Oncology )
N0874 ( Other Identifier: CTEP )
U10CA180821 ( U.S. NIH Grant/Contract )
U10CA025224 ( U.S. NIH Grant/Contract )
First Submitted: August 8, 2008
First Posted: August 11, 2008
Results First Submitted: April 28, 2015
Results First Posted: May 13, 2015
Last Update Posted: December 23, 2019