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Cixutumumab and Temsirolimus in Treating Patients With Locally Recurrent or Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00699491
Recruitment Status : Completed
First Posted : June 18, 2008
Results First Posted : May 21, 2015
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Male Breast Carcinoma
Recurrent Breast Carcinoma
Stage IV Breast Cancer AJCC v6 and v7
Interventions Biological: Cixutumumab
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Drug: Temsirolimus
Enrollment 48
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dose Level 1 Dose Level -1 Dose Level -2 Dose Level -2A Dose Level -2B Phase II
Hide Arm/Group Description
  • 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
  • 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22

Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

  • 20 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
  • 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22

Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

  • 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
  • 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22

Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

  • 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
  • 4 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22

Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

  • 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
  • 5 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22

Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Phase II patients receive the recommended phase II dose determined in the phase I portion.

  • 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
  • 4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22.

Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Period Title: Overall Study
Started 3 2 7 6 8 22
Completed 3 2 7 6 8 22
Not Completed 0 0 0 0 0 0
Arm/Group Title Dose Level 1 Dose Level -1 Dose Level -2 Dose Level -2A Dose Level -2B Phase II Total
Hide Arm/Group Description
  • 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
  • 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22

Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

  • 20 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
  • 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22

Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

  • 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
  • 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22

Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

  • 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
  • 4 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22

Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

  • 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
  • 5 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22

Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Phase II patients receive the recommended phase II dose determined in the phase I portion.

  • 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
  • 4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22.

Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Total of all reporting groups
Overall Number of Baseline Participants 3 2 7 6 8 22 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants 2 participants 7 participants 6 participants 8 participants 22 participants 48 participants
35
(34 to 40)
68
(56 to 80)
49
(36 to 65)
53
(43 to 63)
48.5
(35 to 72)
57
(35 to 82)
48.5
(34 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 2 participants 7 participants 6 participants 8 participants 22 participants 48 participants
Female
3
 100.0%
2
 100.0%
7
 100.0%
6
 100.0%
8
 100.0%
22
 100.0%
48
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 2 participants 7 participants 6 participants 8 participants 22 participants 48 participants
3 2 7 6 8 22 48
1.Primary Outcome
Title Recommended Dose Level for Phase II Testing (RPTD) (Phase I)
Hide Description

The RPTD is defined as the highest dose level at which at most one of 6 patients develops a dose limiting toxicity (DLT) during the first course of treatment and the next highest dose level has 2 or more DLTs. The number of patients in each cohort reporting a DLT is reported.

Dose-limiting toxicities (DLTs) are defined as any of the following adverse events (AEs) that are related to study agent with an attribution of possible, probably, or definite and fulfilling one of the following criteria:

  • Any grade 4 hematologic toxicity
  • Hyperglycemia that cannot be stably controlled with diabetic medication
  • Any grade 3 or 4 non-hematologic toxicity (except asymptomatic medically manageable laboratory abnormalities such as hyperlipidemia, hypophosphatemia, and hypokalemia)
Time Frame During first course
Hide Outcome Measure Data
Hide Analysis Population Description
Patients registered to the Phase I portion of the protocol were analyzed for this endpoint. One patient in Dose Level -1, one patient in Dose Level -2, and two patients in Dose Level -2B discontinued study treatment during Cycle 1 for reasons unrelated to toxicity and were excluded from this endpoint.
Arm/Group Title Dose Level 1 Dose Level -1 Dose Level -2 Dose Level -2A Dose Level -2B
Hide Arm/Group Description:
  • 25 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
  • 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
  • 20 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
  • 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22

Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

  • 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
  • 3 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22

Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

  • 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
  • 4 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22

Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

  • 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22
  • 5 mg/ks cixutumumab IV over 60 minutes on days 1, 8, 15, and 22

Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 3 1 6 6 6
Measure Type: Number
Unit of Measure: DLTs
2 1 1 0 3
2.Primary Outcome
Title Tumor Response Rate (TRR) (Complete Response [CR] or Partial Response [PR]) by the Response Evaluation Criteria in Solid Tumors (RECIST) (Phase II)
Hide Description

A response is defined as a disease burden that meets the RECIST criteria for Complete Response (CR) or Partial Response (PR) on 2 consecutive evaluations at least 6-8 weeks apart.

Complete Response (CR): All of the following must be true:

  1. Disappearance of all target and non-target lesions.
  2. Each target lymph node must have reduction in short axis to <1.0 cm.

Partial Response (PR): At least a 30% decrease in PBSD (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking as reference the baseline measures.

The rate is calculated by dividing the number of patients with a CR or PR by the number of evaluable patients. A ninety percent confidence interval for the true tumor response rate will be calculated using the Duffy-Santer approach.

Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
One patient registered to the Phase II portion of the study was not eligible for this endpoint due to eligibility criteria not being met.
Arm/Group Title Phase II
Hide Arm/Group Description:

Phase II patients receive the recommended phase II dose determined in the phase I portion.

  • 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
  • 4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 21
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of patients with response
0
(0 to 13.3)
3.Secondary Outcome
Title Adverse Events Graded Using the NCI CTCAE Version. 3 (Phase II)
Hide Description Adverse events will be graded using the NCI-CTCAE v3.0 coding scheme. The maximum grade for each adverse event considered to be 'at least possibly related to treatment' will be recorded. Frequency tables will be constructed and the number of patients reporting an adverse event of grade 3 or higher at least possibly related to treatment will be reported.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that received protocol treatment were evaluable for this endpoint.
Arm/Group Title Phase II
Hide Arm/Group Description:

Phase II patients receive the recommended phase II dose determined in the phase I portion.

  • 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
  • 4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: participants
Grade 3+ Adverse Event 8
Grade 4+ Adverse Event 1
4.Secondary Outcome
Title Duration of Response (Phase II)
Hide Description Duration of response is defined for all evaluable patients with changes in disease burden that met the RECIST criteria for CR or PR on 2 consecutive evaluations at least 6-8 weeks apart as the date at which the CR or PR to the date progression is documented. The distribution of response durations will be estimated using the Kaplan-Meier method.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
No patients were eligible for this endpoint.
Arm/Group Title Phase II
Hide Arm/Group Description:

Phase II patients receive the recommended phase II dose determined in the phase I portion.

  • 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
  • 4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Progression Free Survival (PFS) (Phase II)
Hide Description Progression free survival is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. If the patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation was declared to have occurred. In the case of a patient starting treatment and then never returning for any evaluations, the patient will be censored for progression on the last day of therapy was administered. The distribution of progression-free survival times will be estimated using the Kaplan-Meier method.The distribution of PFS times will be estimated using the Kaplan-Meier method.
Time Frame Time from registration to documentation of disease progression, up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
One patient registered to the Phase II portion of the study was not eligible for this endpoint due to eligibility criteria not being met.
Arm/Group Title Phase II
Hide Arm/Group Description:

Phase II patients receive the recommended phase II dose determined in the phase I portion.

  • 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
  • 4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 21
Median (95% Confidence Interval)
Unit of Measure: months
2.0
(1.5 to 3.0)
6.Secondary Outcome
Title Progression Free Survival Rate
Hide Description Progression free survival (PFS) is defined as the time from registration to documentation of disease progression. A point and interval estimate of the 6 month PFS rate will be obtained using the Kaplan-Meier method.
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
One patient registered to the Phase II portion of the study was not eligible for this endpoint due to eligibility criteria not being met.
Arm/Group Title Phase II
Hide Arm/Group Description:

Phase II patients receive the recommended phase II dose determined in the phase I portion.

  • 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
  • 4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
14.3
(5.0 to 40.7)
7.Secondary Outcome
Title Survival Time (Phase II)
Hide Description Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.
Time Frame Time from registration to death due to any cause
Hide Outcome Measure Data
Hide Analysis Population Description
One patient registered to the Phase II portion of the study was not eligible for this endpoint due to eligibility criteria not being met.
Arm/Group Title Phase II
Hide Arm/Group Description:

Phase II patients receive the recommended phase II dose determined in the phase I portion.

  • 15 mg temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
  • 4 mg/kg cixutumumab IV over 60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 21
Median (95% Confidence Interval)
Unit of Measure: months
10.1
(4.9 to 19.1)
Time Frame [Not Specified]
Adverse Event Reporting Description All patients that registered and started protocol treatment were available for adverse events assessment. Adverse Events were assessed during each cycle of treatment.
 
Arm/Group Title Dose Level 1 Dose Level -1 Dose Level -2 Dose Level -2A Dose Level -2B Phase II
Hide Arm/Group Description Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. laboratory biomarker analysis: Correlative studies
All-Cause Mortality
Dose Level 1 Dose Level -1 Dose Level -2 Dose Level -2A Dose Level -2B Phase II
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Dose Level 1 Dose Level -1 Dose Level -2 Dose Level -2A Dose Level -2B Phase II
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      1/2 (50.00%)      1/7 (14.29%)      3/6 (50.00%)      3/8 (37.50%)      7/22 (31.82%)    
Blood and lymphatic system disorders             
Hemoglobin decreased  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 2/6 (33.33%)  2 0/8 (0.00%)  0 1/22 (4.55%)  1
Gastrointestinal disorders             
Mucositis oral  1  0/3 (0.00%)  0 1/2 (50.00%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0 1/8 (12.50%)  1 1/22 (4.55%)  1
Nausea  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  1
Vomiting  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  1
General disorders             
Death  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1 0/8 (0.00%)  0 0/22 (0.00%)  0
Edema limbs  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 1/8 (12.50%)  1 0/22 (0.00%)  0
Fatigue  1  0/3 (0.00%)  0 1/2 (50.00%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 2/22 (9.09%)  2
Pain  1  0/3 (0.00%)  0 1/2 (50.00%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  1
Infections and infestations             
Skin infection  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 1/8 (12.50%)  1 0/22 (0.00%)  0
Investigations             
Alanine aminotransferase increased  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  1
Alkaline phosphatase increased  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  1
Creatinine increased  1  0/3 (0.00%)  0 1/2 (50.00%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 0/22 (0.00%)  0
Platelet count decreased  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 2/22 (9.09%)  2
Metabolism and nutrition disorders             
Anorexia  1  0/3 (0.00%)  0 1/2 (50.00%)  1 0/7 (0.00%)  0 1/6 (16.67%)  1 0/8 (0.00%)  0 0/22 (0.00%)  0
Blood glucose increased  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 2/22 (9.09%)  2
Dehydration  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 1/8 (12.50%)  1 2/22 (9.09%)  2
Musculoskeletal and connective tissue disorders             
Back pain  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  1
Bone pain  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  1
Chest wall pain  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Tumor pain  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 1/8 (12.50%)  1 0/22 (0.00%)  0
Nervous system disorders             
Dizziness  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  1
Peripheral motor neuropathy  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 1/8 (12.50%)  1 0/22 (0.00%)  0
Peripheral sensory neuropathy  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  1
Psychiatric disorders             
Confusion  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1 0/8 (0.00%)  0 0/22 (0.00%)  0
Renal and urinary disorders             
Protein urine positive  1  0/3 (0.00%)  0 0/2 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0 0/8 (0.00%)  0 0/22 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Dyspnea  1  0/3 (0.00%)  0 1/2 (50.00%)  1 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 0/22 (0.00%)  0
Skin and subcutaneous tissue disorders             
Skin ulceration  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  1
Vascular disorders             
Thrombosis  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dose Level 1 Dose Level -1 Dose Level -2 Dose Level -2A Dose Level -2B Phase II
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      2/2 (100.00%)      7/7 (100.00%)      6/6 (100.00%)      8/8 (100.00%)      22/22 (100.00%)    
Blood and lymphatic system disorders             
Hemoglobin decreased  1  3/3 (100.00%)  3 2/2 (100.00%)  3 5/7 (71.43%)  13 6/6 (100.00%)  15 5/8 (62.50%)  10 16/22 (72.73%)  42
Cardiac disorders             
Atrial fibrillation  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  1
Eye disorders             
Flashing vision  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  3
Vision blurred  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 1/8 (12.50%)  1 2/22 (9.09%)  2
Gastrointestinal disorders             
Abdominal pain  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 1/8 (12.50%)  2 1/22 (4.55%)  1
Constipation  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1 2/8 (25.00%)  2 4/22 (18.18%)  6
Diarrhea  1  0/3 (0.00%)  0 0/2 (0.00%)  0 3/7 (42.86%)  5 3/6 (50.00%)  4 0/8 (0.00%)  0 9/22 (40.91%)  17
Dry mouth  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  2
Dyspepsia  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 1/8 (12.50%)  1 1/22 (4.55%)  1
Gingival pain  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  3
Mucositis oral  1  3/3 (100.00%)  5 0/2 (0.00%)  0 6/7 (85.71%)  12 3/6 (50.00%)  7 5/8 (62.50%)  6 12/22 (54.55%)  21
Nausea  1  1/3 (33.33%)  1 1/2 (50.00%)  1 2/7 (28.57%)  2 3/6 (50.00%)  4 2/8 (25.00%)  3 10/22 (45.45%)  17
Oral pain  1  0/3 (0.00%)  0 0/2 (0.00%)  0 1/7 (14.29%)  2 0/6 (0.00%)  0 0/8 (0.00%)  0 0/22 (0.00%)  0
Toothache  1  0/3 (0.00%)  0 0/2 (0.00%)  0 1/7 (14.29%)  2 0/6 (0.00%)  0 0/8 (0.00%)  0 0/22 (0.00%)  0
Vomiting  1  0/3 (0.00%)  0 0/2 (0.00%)  0 1/7 (14.29%)  1 1/6 (16.67%)  1 1/8 (12.50%)  1 8/22 (36.36%)  11
General disorders             
Chills  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  3 0/8 (0.00%)  0 1/22 (4.55%)  1
Edema limbs  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 3/22 (13.64%)  3
Fatigue  1  3/3 (100.00%)  5 0/2 (0.00%)  0 6/7 (85.71%)  12 6/6 (100.00%)  16 6/8 (75.00%)  9 19/22 (86.36%)  52
Fever  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1 0/8 (0.00%)  0 0/22 (0.00%)  0
Pain  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1 1/8 (12.50%)  1 2/22 (9.09%)  3
Immune system disorders             
Hypersensitivity  1  1/3 (33.33%)  1 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  1
Infections and infestations             
Sinusitis  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  1
Skin infection  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  1
Investigations             
Alanine aminotransferase increased  1  0/3 (0.00%)  0 0/2 (0.00%)  0 1/7 (14.29%)  1 1/6 (16.67%)  1 2/8 (25.00%)  2 4/22 (18.18%)  5
Alkaline phosphatase increased  1  0/3 (0.00%)  0 0/2 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0 0/8 (0.00%)  0 6/22 (27.27%)  8
Aspartate aminotransferase increased  1  0/3 (0.00%)  0 1/2 (50.00%)  1 1/7 (14.29%)  1 1/6 (16.67%)  1 2/8 (25.00%)  3 7/22 (31.82%)  10
Bilirubin increased  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  1
Creatinine increased  1  1/3 (33.33%)  1 1/2 (50.00%)  1 1/7 (14.29%)  1 0/6 (0.00%)  0 0/8 (0.00%)  0 8/22 (36.36%)  14
Leukocyte count decreased  1  1/3 (33.33%)  1 1/2 (50.00%)  2 5/7 (71.43%)  8 5/6 (83.33%)  16 3/8 (37.50%)  4 13/22 (59.09%)  32
Lymphocyte count decreased  1  0/3 (0.00%)  0 1/2 (50.00%)  2 2/7 (28.57%)  2 3/6 (50.00%)  9 0/8 (0.00%)  0 4/22 (18.18%)  9
Neutrophil count decreased  1  1/3 (33.33%)  1 1/2 (50.00%)  2 5/7 (71.43%)  6 5/6 (83.33%)  10 2/8 (25.00%)  3 10/22 (45.45%)  24
Platelet count decreased  1  2/3 (66.67%)  2 2/2 (100.00%)  3 3/7 (42.86%)  9 3/6 (50.00%)  7 3/8 (37.50%)  7 13/22 (59.09%)  30
Serum cholesterol increased  1  0/3 (0.00%)  0 0/2 (0.00%)  0 1/7 (14.29%)  1 2/6 (33.33%)  4 0/8 (0.00%)  0 4/22 (18.18%)  5
Weight loss  1  1/3 (33.33%)  1 1/2 (50.00%)  1 4/7 (57.14%)  6 2/6 (33.33%)  9 1/8 (12.50%)  2 8/22 (36.36%)  20
Metabolism and nutrition disorders             
Anorexia  1  3/3 (100.00%)  5 1/2 (50.00%)  1 3/7 (42.86%)  5 5/6 (83.33%)  9 4/8 (50.00%)  5 14/22 (63.64%)  31
Blood bicarbonate decreased  1  0/3 (0.00%)  0 0/2 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0 0/8 (0.00%)  0 0/22 (0.00%)  0
Blood glucose increased  1  3/3 (100.00%)  3 2/2 (100.00%)  2 4/7 (57.14%)  11 6/6 (100.00%)  18 4/8 (50.00%)  6 16/22 (72.73%)  39
Dehydration  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  1
Serum albumin decreased  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 2/22 (9.09%)  2
Serum calcium decreased  1  0/3 (0.00%)  0 0/2 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0 0/8 (0.00%)  0 0/22 (0.00%)  0
Serum calcium increased  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  1
Serum potassium decreased  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  1
Serum sodium decreased  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 2/22 (9.09%)  3
Serum triglycerides increased  1  0/3 (0.00%)  0 0/2 (0.00%)  0 1/7 (14.29%)  1 2/6 (33.33%)  3 0/8 (0.00%)  0 3/22 (13.64%)  3
Musculoskeletal and connective tissue disorders             
Arthralgia  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  1
Back pain  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  1
Bone pain  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  1
Muscle weakness  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  1
Myalgia  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  1
Neck pain  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  1
Pain in extremity  1  0/3 (0.00%)  0 0/2 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Tumor pain  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  1
Nervous system disorders             
Dizziness  1  0/3 (0.00%)  0 1/2 (50.00%)  1 1/7 (14.29%)  4 2/6 (33.33%)  7 1/8 (12.50%)  1 8/22 (36.36%)  13
Dysgeusia  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 2/22 (9.09%)  4
Headache  1  0/3 (0.00%)  0 0/2 (0.00%)  0 1/7 (14.29%)  1 1/6 (16.67%)  1 0/8 (0.00%)  0 3/22 (13.64%)  4
Peripheral sensory neuropathy  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 5/22 (22.73%)  6
Sinus pain  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  3
Taste alteration  1  0/3 (0.00%)  0 0/2 (0.00%)  0 1/7 (14.29%)  1 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  2
Psychiatric disorders             
Agitation  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  1
Anxiety  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  1
Confusion  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  1
Insomnia  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  2
Renal and urinary disorders             
Glomerular filtration rate decreased  1  0/3 (0.00%)  0 1/2 (50.00%)  2 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 0/22 (0.00%)  0
Protein urine positive  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  1
Ureteric obstruction  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  1
Respiratory, thoracic and mediastinal disorders             
Allergic rhinitis  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 1/8 (12.50%)  2 2/22 (9.09%)  4
Cough  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  1
Dyspnea  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 2/22 (9.09%)  2
Epistaxis  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  1
Hemorrhage nasal  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  1
Hypoxia  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  1
Pharyngolaryngeal pain  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  2
Skin and subcutaneous tissue disorders             
Alopecia  1  0/3 (0.00%)  0 1/2 (50.00%)  2 1/7 (14.29%)  1 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  2
Atrophy skin  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  1
Dry skin  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 4/22 (18.18%)  8
Pruritus  1  3/3 (100.00%)  5 0/2 (0.00%)  0 2/7 (28.57%)  4 1/6 (16.67%)  6 0/8 (0.00%)  0 5/22 (22.73%)  12
Rash acneiform  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  1
Rash desquamating  1  3/3 (100.00%)  5 1/2 (50.00%)  1 4/7 (57.14%)  7 3/6 (50.00%)  8 4/8 (50.00%)  5 11/22 (50.00%)  20
Sweating  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  1 0/8 (0.00%)  0 0/22 (0.00%)  0
Vascular disorders             
Flushing  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 1/22 (4.55%)  1
Hypertension  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 0/6 (0.00%)  0 0/8 (0.00%)  0 3/22 (13.64%)  6
Thrombosis  1  0/3 (0.00%)  0 0/2 (0.00%)  0 0/7 (0.00%)  0 1/6 (16.67%)  2 0/8 (0.00%)  0 0/22 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10
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: Cynthia Ma, M.D., Ph.D.
Organization: Washington University School of Medicine
EMail: cma@im.wustl.edu
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00699491    
Other Study ID Numbers: NCI-2009-00284
NCI-2009-00284 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000598057
MC0736 ( Other Identifier: Alliance for Clinical Trials in Oncology )
8129 ( Other Identifier: CTEP )
N01CM00071 ( U.S. NIH Grant/Contract )
N01CM00099 ( U.S. NIH Grant/Contract )
N01CM62201 ( U.S. NIH Grant/Contract )
N01CM62205 ( U.S. NIH Grant/Contract )
N01CM62207 ( U.S. NIH Grant/Contract )
N01CM62209 ( U.S. NIH Grant/Contract )
U10CA180821 ( U.S. NIH Grant/Contract )
U10CA025224 ( U.S. NIH Grant/Contract )
First Submitted: June 17, 2008
First Posted: June 18, 2008
Results First Submitted: May 5, 2015
Results First Posted: May 21, 2015
Last Update Posted: June 13, 2018