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Docetaxel +/- Suramin in 2nd Line Advanced Non-Small Cell Lung Cancer

Sponsor
University of Wisconsin, Madison (Other)
Overall Status
Completed
CT.gov ID
NCT01671332
Collaborator
Medical College of Wisconsin (Other), Optimum Therapeutics, LLC (Industry), Ohio State University (Other)
80
Enrollment
2
Locations
2
Arms
48.5
Actual Duration (Months)
40
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The overall purpose of the study is to determine whether or not the inclusion of suramin to standard treatment with docetaxel improves progression-free survival for patients with advanced non-small cell lung cancer in the second and third line settings.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

The overall purpose of the study is to determine whether or not the inclusion of suramin to standard treatment with docetaxel improves progression-free survival for patients with advanced non-small cell lung cancer in the second and third line settings.

Secondary objectives include:

  • To compare response rate of patients in both treatment arms

  • To compare overall survival of patients in both treatment arms

  • To compare toxicity in both treatment arms

  • To determine whether the survival benefit from suramin is associated with reduced M-phase entry in peripheral blood lymphocytes

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Phase II Study of Suramin and Docetaxel Versus Docetaxel in Non-Small Cell Lung Cancer After Failure of First-Line Chemotherapy
Actual Study Start Date :
Jun 1, 2012
Actual Primary Completion Date :
Jun 11, 2015
Actual Study Completion Date :
Jun 16, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Docetaxel

Drug: Docetaxel
IV over 60 minutes, 75 mg/m2
Other Names:
  • Taxotere

    		•
    Experimental: Docetaxel plus Suramin

    Drug: Suramin
    IV over 30 minutes

    Drug: Docetaxel
    IV over 60 minutes. 56 mg/m2
    Other Names:
  • Taxotere

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free Survival in Months [Up to 1 year]

      Compare progression-free survival (PFS) in participants with advanced NSCLC treated with docetaxel with or without suramin after failure of first-line chemotherapy. PFS is defined as the duration of time from the time of randomization to time of disease progression or death, whichever occurs first.

    Secondary Outcome Measures

    1. Response Rate Per RECIST 1.1 Criteria [Up to 1 year]

      Response rate per RECIST 1.1, as follows: Complete response (CR): Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to <10 mm in short axis Partial response (PR): At least 30% decrease in the sum of longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters Progressive disease (PD): SLD increased by at least 20% from the smallest value on study (including baseline, if that is smallest). The SLD must also demonstrate an absolute increase of at least 5 mm. (Two lesions increasing from 2mm to 3mm, for example, does not qualify). Stable disease (SD): Neither sufficient shrinkage to qualify for PR not sufficient increase to qualify for PD

    2. Overall Survival [Up to 50 months]

      Compare overall survival of participants in both treatment arms.

    3. Number of Participants With Toxicity/Adverse Events From Treatment [Up to 2 years]

      The investigators will compare the toxicity profiles of the two arms of therapy to determine if the docetaxel + suramin has a more favorable toxicity profile than docetaxel alone. This count includes only adverse events considered definitely, probably, or possibly due to treatment.

    4. Evaluation of Peripheral Blood Lymphocytes for DNA Damage-induced Checkpoint Control. [Baseline]

      The investigators hypothesize that suramin in combination with docetaxel improves response rates and survival by increasing the cancer cell population in the M phase of the cell cycle. The G2-M checkpoint control score, defined as (%M-phase arrested cells after cisplatin+suramin)/(%M-phase arrested cells after cisplatin), is an indicator of the effect of suramin on cell accumulation in the M-phase. G2-M checkpoint control was evaluated as a predictor of PFS and OS in participant receiving suramin by linear correlation.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Pathologically proven diagnosis of non-small cell lung cancer

    • Documented disease progression after first-line chemotherapy for non-small cell lung cancer

    • Stable and treated CNS metastasis is allowed

    • Radiation must be completed at least 2 weeks prior to starting protocol treatment

    • Major surgery must be completed at least 4 weeks prior to starting protocol treatment

    • ECOG performance status 0-2

    • Sexually active patients must use adequate contraception

    • Adequate bone marrow function

    • Adequate renal function

    • Adequate liver function

    Exclusion Criteria:

    • Severe hypersensitivity reaction to docetaxel

    • Pre-existing grade 3 or 4 neuropathy

    • Women who are pregnant or breastfeeding

    • Uncontrolled intercurrent illness

    • Receipt of 3 or more prior chemotherapy regimens

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Wisconsin Carbone Comprehensive Cancer Center Madison Wisconsin United States 53792
    2 Medical College of Wisconsin Milwaukee Wisconsin United States

    Sponsors and Collaborators

    • University of Wisconsin, Madison
    • Medical College of Wisconsin
    • Optimum Therapeutics, LLC
    • Ohio State University

    Investigators

    • Principal Investigator: Anne M Traynor, MD, University of Wisconsin, Madison
    • Study Chair: Rafael Santana-Davila, MD, Medical College of Wisconsin

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    University of Wisconsin, Madison
    ClinicalTrials.gov Identifier:
    NCT01671332
    Other Study ID Numbers:
    • CO11508
    • A534260
    • SMPH/MEDICINE/MEDICINE*H
    • 2012-0118
    • NCI-2012-01113
    First Posted:
    Aug 23, 2012
    Last Update Posted:
    May 12, 2020
    Last Verified:
    May 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Wisconsin, Madison
    Carcinoma, non small cell lung
    Second line
    Third line
    Additional relevant MeSH terms:
    Carcinoma, Non-Small-Cell Lung
    Suramin
    Docetaxel

    Study Results

    Participant Flow

    Recruitment Details Recruitment occurred from June 2012 through April 2014.
    Pre-assignment Detail
    Arm/Group Title Docetaxel Docetaxel Plus Suramin
    Arm/Group Description Docetaxel: IV over 60 minutes, 75 mg/m2 Participants with disease progression on the docetaxel arm were allowed to cross over to the suramin arm. Suramin: IV over 30 minutes Docetaxel: IV over 60 minutes. 56 mg/m2
    Period Title: Overall Study
    STARTED 40 40
    Crossed Over to Docetaxel Plus Suramin 0 13
    COMPLETED 39 39
    NOT COMPLETED 1 1

    Baseline Characteristics

    Arm/Group Title Docetaxel Docetaxel Plus Suramin Total
    Arm/Group Description Docetaxel: IV over 60 minutes, 75 mg/m2 Participants with disease progression on the docetaxel arm were allowed to cross over to the suramin arm. Suramin: IV over 30 minutes Docetaxel: IV over 60 minutes. 56 mg/m2 Total of all reporting groups
    Overall Participants 40 40 80
    Age, Customized (participants) [Number]
    18-39 years
    0
    0%
    0
    0%
    0
    0%
    40-49 years
    1
    2.5%
    2
    5%
    3
    3.8%
    50-59 years
    18
    45%
    11
    27.5%
    29
    36.3%
    60-69 years
    17
    42.5%
    16
    40%
    33
    41.3%
    70-79 years
    3
    7.5%
    9
    22.5%
    12
    15%
    80-89 years
    1
    2.5%
    2
    5%
    3
    3.8%
    Sex: Female, Male (Count of Participants)
    Female
    13
    32.5%
    22
    55%
    35
    43.8%
    Male
    27
    67.5%
    18
    45%
    45
    56.3%
    Race/Ethnicity, Customized (participants) [Number]
    White, Not of Hispanic Origin
    38
    95%
    35
    87.5%
    73
    91.3%
    Black or African American, Not of Hispanic Origin
    2
    5%
    2
    5%
    4
    5%
    Hispanic or Latino
    0
    0%
    1
    2.5%
    1
    1.3%
    Asian
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    American Indian or Alaska Native
    0
    0%
    2
    5%
    2
    2.5%
    Region of Enrollment (participants) [Number]
    United States
    40
    100%
    40
    100%
    80
    100%

    Outcome Measures

    1. Primary Outcome
    Title Progression-free Survival in Months
    Description Compare progression-free survival (PFS) in participants with advanced NSCLC treated with docetaxel with or without suramin after failure of first-line chemotherapy. PFS is defined as the duration of time from the time of randomization to time of disease progression or death, whichever occurs first.
    Time Frame Up to 1 year

    Outcome Measure Data

    Analysis Population Description
    The 13 participants that crossed over to the Docetaxel plus Suramin arm did so after progressing on the standard arm. Their progression-free survival was therefore purely determined by the arm of randomization and not influenced by the cross-over.
    Arm/Group Title Docetaxel Docetaxel Plus Suramin
    Arm/Group Description Docetaxel: IV over 60 minutes, 75 mg/m2 Participants with disease progression on the docetaxel arm were allowed to cross over to the suramin arm. Suramin: IV over 30 minutes Docetaxel: IV over 60 minutes. 56 mg/m2
    Measure Participants 40 40
    Median (95% Confidence Interval) [months]
    2.8
    1.6
    2. Secondary Outcome
    Title Response Rate Per RECIST 1.1 Criteria
    Description Response rate per RECIST 1.1, as follows: Complete response (CR): Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to <10 mm in short axis Partial response (PR): At least 30% decrease in the sum of longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters Progressive disease (PD): SLD increased by at least 20% from the smallest value on study (including baseline, if that is smallest). The SLD must also demonstrate an absolute increase of at least 5 mm. (Two lesions increasing from 2mm to 3mm, for example, does not qualify). Stable disease (SD): Neither sufficient shrinkage to qualify for PR not sufficient increase to qualify for PD
    Time Frame Up to 1 year

    Outcome Measure Data

    Analysis Population Description
    The 13 participants that crossed over to the Docetaxel plus Suramin arm did so after progressing on the standard arm. Their response rate was determined by the arm of randomization and not influenced by the cross-over.
    Arm/Group Title Docetaxel Docetaxel Plus Suramin
    Arm/Group Description Docetaxel: IV over 60 minutes, 75 mg/m2 Participants with disease progression on the docetaxel arm were allowed to cross over to the suramin arm. Suramin: IV over 30 minutes Docetaxel: IV over 60 minutes. 56 mg/m2
    Measure Participants 40 40
    Partial Response
    1
    2.5%
    3
    7.5%
    Stable Disease
    17
    42.5%
    11
    27.5%
    Progressive Disease
    17
    42.5%
    25
    62.5%
    Not Assessed
    5
    12.5%
    1
    2.5%
    3. Secondary Outcome
    Title Overall Survival
    Description Compare overall survival of participants in both treatment arms.
    Time Frame Up to 50 months

    Outcome Measure Data

    Analysis Population Description
    The 13 participants that crossed over did so after progressing on the standard arm. The overall survival was determined for the arm of randomization without regard of cross-over. Cross-over was provided as option for participants to have the possible benefit of the new treatment.
    Arm/Group Title Docetaxel Docetaxel Plus Suramin
    Arm/Group Description Docetaxel: IV over 60 minutes, 75 mg/m2 Participants with disease progression on the docetaxel arm were allowed to cross over to the suramin arm. Suramin: IV over 30 minutes Docetaxel: IV over 60 minutes. 56 mg/m2
    Measure Participants 40 40
    Median (95% Confidence Interval) [months]
    5.3
    4.1
    4. Secondary Outcome
    Title Number of Participants With Toxicity/Adverse Events From Treatment
    Description The investigators will compare the toxicity profiles of the two arms of therapy to determine if the docetaxel + suramin has a more favorable toxicity profile than docetaxel alone. This count includes only adverse events considered definitely, probably, or possibly due to treatment.
    Time Frame Up to 2 years

    Outcome Measure Data

    Analysis Population Description
    The 13 participants that crossed over did so after progressing on the standard arm. Reported here are the number of participants who experienced adverse events on the arm of randomization.
    Arm/Group Title Docetaxel Docetaxel Plus Suramin
    Arm/Group Description Docetaxel: IV over 60 minutes, 75 mg/m2 Participants with disease progression on the docetaxel arm were allowed to cross over to the suramin arm. Suramin: IV over 30 minutes Docetaxel: IV over 60 minutes. 56 mg/m2
    Measure Participants 40 40
    Count of Participants [Participants]
    35
    87.5%
    31
    77.5%
    5. Secondary Outcome
    Title Evaluation of Peripheral Blood Lymphocytes for DNA Damage-induced Checkpoint Control.
    Description The investigators hypothesize that suramin in combination with docetaxel improves response rates and survival by increasing the cancer cell population in the M phase of the cell cycle. The G2-M checkpoint control score, defined as (%M-phase arrested cells after cisplatin+suramin)/(%M-phase arrested cells after cisplatin), is an indicator of the effect of suramin on cell accumulation in the M-phase. G2-M checkpoint control was evaluated as a predictor of PFS and OS in participant receiving suramin by linear correlation.
    Time Frame Baseline

    Outcome Measure Data

    Analysis Population Description
    All participants who yielded good quality PBL samples were included.
    Arm/Group Title Docetaxel Docetaxel Plus Suramin
    Arm/Group Description Docetaxel: IV over 60 minutes, 75 mg/m2 Participants with disease progression on the docetaxel arm were allowed to cross over to the suramin arm. Suramin: IV over 30 minutes Docetaxel: IV over 60 minutes. 56 mg/m2
    Measure Participants 18 28
    Mean (Standard Deviation) [G2-M checkpoint control score]
    0.91
    (0.37)
    1.30
    (0.89)

    Adverse Events

    Time Frame Adverse events were reported from on-study through 30 days after last treatment dose, or until resolution/ stabilization of AEs occurred if longer than 30 days.
    Adverse Event Reporting Description AEs are reported by toxicity category. All Cause Mortality includes death greater than 30 days after the subject's off treatment date. SAEs and AEs are reported for all participants randomized to the Docetaxel arm (N=40), and all participants both randomized (N=40) and crossed over to (N=13) to the Docetaxel and Suramin arm, for a total of N=53.
    Arm/Group Title Docetaxel Docetaxel Plus Suramin
    Arm/Group Description Docetaxel: IV over 60 minutes, 75 mg/m2 Participants with disease progression on the docetaxel arm were allowed to cross over to the suramin arm. Suramin: IV over 30 minutes Docetaxel: IV over 60 minutes. 56 mg/m2
    All Cause Mortality
    Docetaxel Docetaxel Plus Suramin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 40/40 (100%) 37/40 (92.5%)
    Serious Adverse Events
    Docetaxel Docetaxel Plus Suramin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 19/40 (47.5%) 26/53 (49.1%)
    Blood and lymphatic system disorders
    Anemia 0/40 (0%) 0 3/53 (5.7%) 3
    Cardiac disorders
    Atrial fibrillation 0/40 (0%) 0 4/53 (7.5%) 4
    Chest pain 0/40 (0%) 0 1/53 (1.9%) 1
    Febrile neutropenia 2/40 (5%) 3 2/53 (3.8%) 2
    Myocardial infarction 0/40 (0%) 0 1/53 (1.9%) 1
    Pericarditis 1/40 (2.5%) 1 0/53 (0%) 0
    Sinus tachycardia 0/40 (0%) 0 1/53 (1.9%) 1
    Supraventricular tachycardia 0/40 (0%) 0 1/53 (1.9%) 1
    Gastrointestinal disorders
    Abdominal pain 0/40 (0%) 0 1/53 (1.9%) 1
    Colitis 1/40 (2.5%) 1 0/53 (0%) 0
    Constipation 0/40 (0%) 0 2/53 (3.8%) 2
    Dysphagia 1/40 (2.5%) 1 0/53 (0%) 0
    Esophageal obstruction 1/40 (2.5%) 1 0/53 (0%) 0
    Lower gastrointestinal hemorrhage 0/40 (0%) 0 1/53 (1.9%) 1
    Nausea 0/40 (0%) 0 1/53 (1.9%) 1
    Vomiting 0/40 (0%) 0 1/53 (1.9%) 1
    General disorders
    Death NOS 3/40 (7.5%) 3 5/53 (9.4%) 5
    Fatigue 1/40 (2.5%) 1 2/53 (3.8%) 2
    Gait disturbance 0/40 (0%) 0 2/53 (3.8%) 2
    Multi-organ failure 2/40 (5%) 2 0/53 (0%) 0
    Immune system disorders
    Anaphylaxis 1/40 (2.5%) 1 0/53 (0%) 0
    Infections and infestations
    Catheter related infection 0/40 (0%) 0 1/53 (1.9%) 1
    Lung infection 1/40 (2.5%) 1 2/53 (3.8%) 2
    Pharyngitis 0/40 (0%) 0 1/53 (1.9%) 1
    Sepsis 1/40 (2.5%) 1 3/53 (5.7%) 3
    Skin infection 0/40 (0%) 0 1/53 (1.9%) 1
    Soft tissue infection 0/40 (0%) 0 1/53 (1.9%) 2
    Urinary tract infection 0/40 (0%) 0 1/53 (1.9%) 1
    Injury, poisoning and procedural complications
    Radiation recall reaction (dermatologic) 1/40 (2.5%) 1 0/53 (0%) 0
    Investigations
    Aspartate aminotransferase increased 0/40 (0%) 0 1/53 (1.9%) 1
    INR increased 0/40 (0%) 0 1/53 (1.9%) 1
    Alanine aminotransferase increased 0/40 (0%) 0 1/53 (1.9%) 1
    Metabolism and nutrition disorders
    Dehydration 1/40 (2.5%) 1 1/53 (1.9%) 1
    Hypoalbuminemia 0/40 (0%) 0 2/53 (3.8%) 2
    Hypocalcemia 0/40 (0%) 0 1/53 (1.9%) 1
    Hypokalemia 0/40 (0%) 0 1/53 (1.9%) 1
    Hyponatremia 0/40 (0%) 0 3/53 (5.7%) 3
    Hyperglycemia 0/40 (0%) 0 1/53 (1.9%) 1
    Musculoskeletal and connective tissue disorders
    Back pain 1/40 (2.5%) 1 2/53 (3.8%) 2
    Generalized muscle weakness 0/40 (0%) 0 1/53 (1.9%) 1
    Muscle weakness upper limb 1/40 (2.5%) 1 0/53 (0%) 0
    Myalgia 1/40 (2.5%) 1 1/53 (1.9%) 1
    Muscle Weakness Right-Sided 1/40 (2.5%) 1 0/53 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other 0/40 (0%) 0 1/53 (1.9%) 1
    Nervous system disorders
    Dizziness 0/40 (0%) 0 1/53 (1.9%) 1
    Headache 0/40 (0%) 0 1/53 (1.9%) 1
    Intracranial hemorrhage 0/40 (0%) 0 1/53 (1.9%) 1
    Peripheral sensory neuropathy 2/40 (5%) 2 1/53 (1.9%) 1
    Stroke 0/40 (0%) 0 1/53 (1.9%) 1
    Psychiatric disorders
    Anxiety 0/40 (0%) 0 2/53 (3.8%) 2
    Confusion 0/40 (0%) 0 1/53 (1.9%) 1
    Renal and urinary disorders
    Urinary retention 1/40 (2.5%) 1 0/53 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Bronchopulmonary hemorrhage 1/40 (2.5%) 1 0/53 (0%) 0
    Dyspnea 1/40 (2.5%) 1 5/53 (9.4%) 5
    Hypoxia 1/40 (2.5%) 1 3/53 (5.7%) 3
    Pleural effusion 0/40 (0%) 0 3/53 (5.7%) 3
    Pneumonitis 0/40 (0%) 0 2/53 (3.8%) 2
    Respiratory failure 1/40 (2.5%) 1 1/53 (1.9%) 1
    Vascular disorders
    Hypertension 0/40 (0%) 0 1/53 (1.9%) 1
    Hypotension 0/40 (0%) 0 2/53 (3.8%) 2
    Peripheal ischemia 0/40 (0%) 0 1/53 (1.9%) 1
    Thromboembolic Event 3/40 (7.5%) 3 1/53 (1.9%) 1
    Other (Not Including Serious) Adverse Events
    Docetaxel Docetaxel Plus Suramin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 39/40 (97.5%) 49/53 (92.5%)
    Blood and lymphatic system disorders
    Anemia 8/40 (20%) 9 14/53 (26.4%) 15
    Blood any lymphatic system disorders - Other 2/40 (5%) 3 0/53 (0%) 0
    Febrile neutropenia 3/40 (7.5%) 3 1/53 (1.9%) 1
    Cardiac disorders
    Palpitations 0/40 (0%) 0 1/53 (1.9%) 1
    Supraventricular tachycardia 0/40 (0%) 0 2/53 (3.8%) 2
    Eye disorders
    Blurred vision 0/40 (0%) 0 1/53 (1.9%) 1
    Watering eyes 2/40 (5%) 3 1/53 (1.9%) 4
    Gastrointestinal disorders
    Abdominal pain 1/40 (2.5%) 1 2/53 (3.8%) 2
    Constipation 1/40 (2.5%) 1 4/53 (7.5%) 5
    Diarrhea 3/40 (7.5%) 4 3/53 (5.7%) 4
    Dyspepsia 0/40 (0%) 0 4/53 (7.5%) 4
    Gastrointestinal disorders - Other 1/40 (2.5%) 1 2/53 (3.8%) 3
    Mucositis oral 6/40 (15%) 6 6/53 (11.3%) 6
    Nausea 7/40 (17.5%) 9 10/53 (18.9%) 12
    Pancreatitis 0/40 (0%) 0 1/53 (1.9%) 1
    Salivary duct inflammation 0/40 (0%) 0 1/53 (1.9%) 1
    Stomach pain 1/40 (2.5%) 1 0/53 (0%) 0
    Vomiting 3/40 (7.5%) 3 3/53 (5.7%) 4
    General disorders
    Death NOS 2/40 (5%) 2 5/53 (9.4%) 5
    Edema limbs 4/40 (10%) 4 1/53 (1.9%) 1
    Fatigue 18/40 (45%) 24 22/53 (41.5%) 35
    Fever 3/40 (7.5%) 3 1/53 (1.9%) 1
    General disorders and administration site conditions - Other 0/40 (0%) 0 1/53 (1.9%) 1
    Infusion related reaction 1/40 (2.5%) 1 1/53 (1.9%) 1
    Malaise 0/40 (0%) 0 2/53 (3.8%) 2
    Non-cardiac chest pain 0/40 (0%) 0 2/53 (3.8%) 2
    Pain 5/40 (12.5%) 9 3/53 (5.7%) 3
    Infections and infestations
    Bronchial infection 0/40 (0%) 0 1/53 (1.9%) 1
    Lung infection 4/40 (10%) 4 1/53 (1.9%) 2
    Mucosal infection 1/40 (2.5%) 1 6/53 (11.3%) 6
    Pharyngitis 1/40 (2.5%) 2 0/53 (0%) 0
    Sinusitis 0/40 (0%) 0 1/53 (1.9%) 1
    Upper respiratory infection 0/40 (0%) 0 1/53 (1.9%) 1
    Urinary tract infection 0/40 (0%) 0 2/53 (3.8%) 2
    Investigations
    Alanine aminotransferase increased 1/40 (2.5%) 1 1/53 (1.9%) 1
    Alkaline phosphatase increased 2/40 (5%) 2 2/53 (3.8%) 2
    Aspartate aminotransferase increased 1/40 (2.5%) 1 5/53 (9.4%) 5
    Cardiac troponin I increased 0/40 (0%) 0 1/53 (1.9%) 1
    CPK increased 0/40 (0%) 0 1/53 (1.9%) 1
    Creatinine increased 1/40 (2.5%) 1 1/53 (1.9%) 1
    Ejection fraction decreased 0/40 (0%) 0 1/53 (1.9%) 1
    INR increased 0/40 (0%) 0 2/53 (3.8%) 2
    Lymphocyte count decreased 9/40 (22.5%) 26 9/53 (17%) 18
    Neutrophil count decreased 16/40 (40%) 27 8/53 (15.1%) 16
    Platelet count decreased 2/40 (5%) 2 2/53 (3.8%) 2
    White blood cell decreased 16/40 (40%) 27 10/53 (18.9%) 20
    Metabolism and nutrition disorders
    Anorexia 6/40 (15%) 8 10/53 (18.9%) 10
    Dehydration 3/40 (7.5%) 3 7/53 (13.2%) 8
    Hyperglycemia 4/40 (10%) 4 7/53 (13.2%) 8
    Hypoalbuminemia 2/40 (5%) 5 6/53 (11.3%) 6
    Hypocalcemia 1/40 (2.5%) 1 0/53 (0%) 0
    Hypoglycemia 1/40 (2.5%) 1 0/53 (0%) 0
    Hypokalemia 0/40 (0%) 0 7/53 (13.2%) 9
    Hyponatremia 3/40 (7.5%) 3 6/53 (11.3%) 6
    Musculoskeletal and connective tissue disorders
    Arthralgia 1/40 (2.5%) 1 1/53 (1.9%) 1
    Arthritis 1/40 (2.5%) 1 1/53 (1.9%) 1
    Back pain 7/40 (17.5%) 7 3/53 (5.7%) 3
    Bone pain 0/40 (0%) 0 1/53 (1.9%) 1
    Generalized muscle weakness 3/40 (7.5%) 3 5/53 (9.4%) 7
    Muscle weakness right-sided 1/40 (2.5%) 1 0/53 (0%) 0
    Musculoskeletal and connective tissue disorder - Other 1/40 (2.5%) 1 0/53 (0%) 0
    Myalgia 2/40 (5%) 2 2/53 (3.8%) 2
    Pain in extremity 1/40 (2.5%) 1 1/53 (1.9%) 2
    Nervous system disorders
    Ataxia 1/40 (2.5%) 1 0/53 (0%) 0
    Dizziness 0/40 (0%) 0 2/53 (3.8%) 2
    Dysgeusia 2/40 (5%) 2 3/53 (5.7%) 5
    Headache 0/40 (0%) 0 1/53 (1.9%) 1
    Nervous system disorders - Other 0/40 (0%) 0 2/53 (3.8%) 2
    Peripheral motor neurpathy 2/40 (5%) 2 0/53 (0%) 0
    Peripheral sensory neuropathy 11/40 (27.5%) 11 6/53 (11.3%) 8
    Syncope 1/40 (2.5%) 1 0/53 (0%) 0
    Psychiatric disorders
    Anxiety 0/40 (0%) 0 1/53 (1.9%) 1
    Depression 1/40 (2.5%) 1 0/53 (0%) 0
    Insomnia 0/40 (0%) 0 2/53 (3.8%) 3
    Renal and urinary disorders
    Chronic kidney disease 0/40 (0%) 0 1/53 (1.9%) 1
    Respiratory, thoracic and mediastinal disorders
    Allergic rhinitis 1/40 (2.5%) 1 1/53 (1.9%) 1
    Cough 1/40 (2.5%) 1 3/53 (5.7%) 3
    Dyspnea 8/40 (20%) 9 11/53 (20.8%) 13
    Hypoxia 1/40 (2.5%) 1 3/53 (5.7%) 3
    Pleural effusion 0/40 (0%) 0 2/53 (3.8%) 3
    Pleuritic pain 0/40 (0%) 0 1/53 (1.9%) 1
    Pneumonitis 2/40 (5%) 2 2/53 (3.8%) 2
    Postnasal drip 0/40 (0%) 0 1/53 (1.9%) 1
    Productive cough 1/40 (2.5%) 1 1/53 (1.9%) 2
    Respiratory, thoracic and mediastinal disorders - Other 1/40 (2.5%) 1 0/53 (0%) 0
    Sore throat 1/40 (2.5%) 1 0/53 (0%) 0
    Voice alteration 0/40 (0%) 0 1/53 (1.9%) 1
    Skin and subcutaneous tissue disorders
    Alopecia 8/40 (20%) 8 8/53 (15.1%) 9
    Dry skin 3/40 (7.5%) 3 0/53 (0%) 0
    Nail ridging 0/40 (0%) 0 1/53 (1.9%) 1
    Pain of skin 1/40 (2.5%) 1 0/53 (0%) 0
    Palmar-plantar erythrodysesthesia syndrome 1/40 (2.5%) 2 1/53 (1.9%) 1
    Pruritus 2/40 (5%) 3 0/53 (0%) 0
    Rash acneiform 0/40 (0%) 0 1/53 (1.9%) 1
    Rash maculo-papular 2/40 (5%) 2 1/53 (1.9%) 1
    Skin and subcutaneous tissue disorders - Other 0/40 (0%) 0 2/53 (3.8%) 2
    Urticaria 1/40 (2.5%) 1 0/53 (0%) 0
    Vascular disorders
    Hot flashes 1/40 (2.5%) 1 0/53 (0%) 0
    Hypertension 4/40 (10%) 7 4/53 (7.5%) 10
    Superficial thrombophlebitis 1/40 (2.5%) 1 0/53 (0%) 0
    Thromboembolic event 3/40 (7.5%) 4 2/53 (3.8%) 2

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Anne Traynor
    Organization University of Wisconsin
    Phone 608-262-5092
    Email amt@medicine.wisc.edu
    Responsible Party:
    University of Wisconsin, Madison
    ClinicalTrials.gov Identifier:
    NCT01671332
    Other Study ID Numbers:
    • CO11508
    • A534260
    • SMPH/MEDICINE/MEDICINE*H
    • 2012-0118
    • NCI-2012-01113
    First Posted:
    Aug 23, 2012
    Last Update Posted:
    May 12, 2020
    Last Verified:
    May 1, 2020