Adj TC + Herceptin Early Stage Breast Cancer

Sponsor
US Oncology Research (Industry)
Overall Status
Completed
CT.gov ID
NCT00493649
Collaborator
Sanofi (Industry)
493
69
1
70
7.1
0.1

Study Details

Study Description

Brief Summary

The purpose of this research study is to find out what effects (good and bad) docetaxel/cyclophosphamide (brand names: Taxotere and Cytoxan, or TC) plus trastuzumab (brand name: Herceptin, or H) has HER2+ breast cancer.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
493 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Trial of Adjuvant TC (Docetaxel/Cyclophosphamide) Plus Trastuzumab in HER2-Positive Early Stage Breast Cancer Patients
Study Start Date :
Jun 1, 2007
Actual Primary Completion Date :
Apr 1, 2013
Actual Study Completion Date :
Apr 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: TC+H

On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive, in this order: docetaxel (Taxotere) 75 mg/m2 IV (over 1 hour), plus cyclophosphamide (Cytoxan) 600 mg/m2 IV (over 15-30 minutes), plus weekly trastuzumab (Herceptin) 4 mg/kg IV (loading dose, over 90 minutes Day 1, Cycle 1 only) and 2 mg/kg IV (over 30-60 minutes on Days 1, 8, and 15) thereafter.

Drug: Taxotere
On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive, in this order: docetaxel 75 mg/m2 IV (over 1 hour), plus cyclophosphamide 600 mg/m2 IV (over 15-30 minutes), plus weekly trastuzumab 4 mg/kg IV (loading dose, over 90 minutes Day 1, Cycle 1 only) and 2 mg/kg IV (over 30-60 minutes on Days 1, 8, and 15) thereafter. Once 4 cycles of TC+H have been received, patients will continue with trastuzumab 6 mg/kg every 3 weeks to complete 1 year of anti-HER2 therapy as per the current standard of care. The anticipated time to study completion is 5 years.
Other Names:
  • docetaxel
  • Drug: Cytoxan
    On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive, in this order: docetaxel 75 mg/m2 IV (over 1 hour), plus cyclophosphamide 600 mg/m2 IV (over 15-30 minutes), plus weekly trastuzumab 4 mg/kg IV (loading dose, over 90 minutes Day 1, Cycle 1 only) and 2 mg/kg IV (over 30-60 minutes on Days 1, 8, and 15) thereafter. Once 4 cycles of TC+H have been received, patients will continue with trastuzumab 6 mg/kg every 3 weeks to complete 1 year of anti-HER2 therapy as per the current standard of care. The anticipated time to study completion is 5 years.
    Other Names:
  • cyclophosphamide
  • Drug: Herceptin
    On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive, in this order: docetaxel 75 mg/m2 IV (over 1 hour), plus cyclophosphamide 600 mg/m2 IV (over 15-30 minutes), plus weekly trastuzumab 4 mg/kg IV (loading dose, over 90 minutes Day 1, Cycle 1 only) and 2 mg/kg IV (over 30-60 minutes on Days 1, 8, and 15) thereafter. Once 4 cycles of TC+H have been received, patients will continue with trastuzumab 6 mg/kg every 3 weeks to complete 1 year of anti-HER2 therapy as per the current standard of care. The anticipated time to study completion is 5 years.
    Other Names:
  • trastuzumab
  • Outcome Measures

    Primary Outcome Measures

    1. Disease-free Survival (DFS) Rate at 2 Years in TOP2A-amplified and in TOP2A-nonamplified HER2+ ESBC Patients Treated With TC+H. [2 years]

      DFS was measured from the date of registration to either the date the patient was first recorded as having disease recurrence, or the date of death due to any causes before recurrence. If a patient had not recurred or died, DFS was censored at the date of last follow-up.

    Secondary Outcome Measures

    1. Overall Survival (OS) Rate at 2 Years in TOP2A-amplified and in TOP2A-nonamplified HER2+ ESBC Patients Treated With TC+H. [2 years]

      OS is measured from the date of registration to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.

    2. DFS by cMyc Expression in This Population of HER2+ ESBC Patients Treated With TC+H. [2 years]

      DFS was measured from the date of registration to either the date the patient was first recorded as having disease recurrence, or the date of death due to any causes before recurrence. If a patient had not recurred or died, DFS was censored at the date of last follow-up.

    3. OS by cMyc Expression in This Population of HER2+ ESBC Patients Treated With TC+H. [2 years]

      OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    A woman will be eligible for inclusion in this study if she meets all of the following criteria:

    • Has HER2+ (IHC staining of 3+ [uniform, intense membrane staining of >30% of invasive tumor cells], or a FISH result of .6 HER2 gene copies per nucleus or a FISH ratio [HER2 gene signals to chromosome 17 signals] of >2.2; patients with equivocal FISH ratio results 1.8-2.2 are also eligible if 3+ IHC) (Appendix IX); Stage I, IIA, IIB, or IIIA T1-3N1-3M0 disease. At the discretion of the Treating Physician, patients with 4+ nodes with other factors such as patient choice, older age, preexisting cardiac disease with normal MUGA or ECHO may be enrolled into a separate subgroup.

    • Has operable, histologically confirmed, invasive carcinoma of the breast.

    • Has known ER and PR status

    • Has adequate tumor specimen available for FISH analysis of TOP2A status (See Appendix VII)

    • Has had no prior chemotherapy unless it was given >5 years ago for breast cancer or other cancer

    • Has an ECOG Performance Status (PS) 0-1

    • Age >18 to <70 years old.

    • Has laboratory values of: See protocol for specific details

    • Has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) and alkaline phosphatase (ALP) within the ranges shown below. In determining eligibility the more abnormal of the 2 values (AST or ALT) should be used. See protocol for specific details

    • Has complete surgical resection of the primary breast tumor: either lumpectomy or mastectomy with sentinel lymph node or axillary dissection.

    • It has been <84 days since the date of definitive surgery, and there is adequate wound healing as determined by the Treating Physician

    • Has no evidence of metastatic disease by physical examination and x-ray; appropriate scans as needed by each individual patient (eg, bone scan; abdominal, chest CT; PET or PET/CT; ultrasound; or MRI should indicate no evidence of metastatic disease.

    • Has normal cardiac function as evidenced by a LVEF >50%, but must be within normal limits (WNL) by institutional standard, as determined by multiple gated acquisition (MUGA) scan. An echocardiogram (ECHO). The same modality must be used throughout the study to evaluate LVEF. Ejection fraction (EF) as determined by ECHO must be WNL by institutional standard.

    • Has a negative serum pregnancy test within 7 calendar days prior to registration (female patients of childbearing potential [not surgically sterilized and between menarche and 1 year postmenopause]).

    • If fertile, patient has agreed to use an acceptable method of birth control (barrier contraceptive) to avoid pregnancy for the duration of the study and for a period of 3 months thereafter

    • Has signed a Patient Informed Consent Form

    • Has signed a Patient Authorization Form

    Exclusion Criteria:
    A woman will be excluded from this study if she meets any of the following criteria:
    • Has any evidence of disease following complete surgical resection of the primary tumor and metastatic workup

    • Has Stage IIIB breast cancer (T4 disease; ie, patients with fixed tumors, peau d'orange skin changes, skin ulcerations, or inflammatory changes).

    • Has Stage IV breast cancer (M1 disease on TNM staging system)

    • Had prior chemotherapy for breast cancer or other cancer within the last 5 years (no neoadjuvant chemotherapy in this study is permitted)

    • Has a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80

    • Has had a myocardial infarction (MI) within 6 months of trial enrollment, or has New York Heart Association (NYHA) Class II or greater heart failure (see Appendix III), uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic changes

    • Has abnormal baseline MUGA (or ECHO) (<50%, or less than institutional LLN)

    • Is receiving concurrent immunotherapy, hormonal therapy, or radiation therapy. Adjuvant hormonal therapy, if needed, may be given during radiation therapy and during treatment with trastuzumab after completion of chemotherapy.

    • Is receiving concurrent investigational therapy or has received such therapy within the past 30 calendar days

    • Has peripheral neuropathy >Grade 1

    • Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious viral (including clinically defined AIDS), bacterial or fungal infection; or history of uncontrolled seizures, or diabetes, or CNS disorders deemed by the Treating Physician to be clinically significant, precluding informed consent

    • Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be HIV positive

    • Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix), which could affect the diagnosis or assessment of any of the study drugs

    • Is an obese patient to whom the Treating Physician would not be comfortable administering full doses of study drugs as calculated by the BSA. Obese patients will be treated based on actual body weight. Obese patients treated with full doses based on actual BSA are eligible

    • Is a pregnant or breastfeeding woman

    • Is deemed unable to comply with requirements of study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Birmingham Hematology and Oncology Birmingham Alabama United States 35205
    2 Hematology Oncology Associates Phoenix Arizona United States 85012
    3 Northern AZ Hematology & Oncology Associates Sedona Arizona United States 86336
    4 Arizona Oncology Associates DBA HOPE Tucson Arizona United States 85704
    5 Rocky Mountain Cancer Center-Rose Denver Colorado United States 80220
    6 Connecticut Oncology & Hematology, LLP Torrington Connecticut United States 06790
    7 Florida Cancer Institute New Port richey Florida United States 34655
    8 Ocala Oncology Center Ocala Florida United States 34474
    9 Cancer Centers of Florida, P.A. Ocoee Florida United States 34761
    10 Hematology Oncology Associates of IL Chicago Illinois United States 60611
    11 Cancer Care & Hematology Specialists of Chicagoland Niles Illinois United States 60714
    12 Central Indiana Cancer Centers Indianapolis Indiana United States 46227
    13 Hope Center Terre Haute Indiana United States 47802
    14 Kansas City Cancer Centers-Southwest Overland Park Kansas United States 66210
    15 Maryland Oncology Hematology, P.A. Columbia Maryland United States 21044
    16 Alliance Hematology Oncology P.A. Westminster Maryland United States 21157
    17 Minnesota Oncology Hematology, P.A. Minneapolis Minnesota United States 55404
    18 Missouri Cancer Associates Columbia Missouri United States 65201
    19 Arch Medical Services, Inc. St. Louis Missouri United States 63141
    20 Comprehensive Cancer Centers of Nevada Henderson Nevada United States 89052
    21 Hematology-Oncology Associates of NNJ, P.A. Morristown New Jersey United States 07960
    22 New Mexico Cancer Care Associates Santa Fe New Mexico United States 87505
    23 New York Oncology Hematology, P.C. Albany New York United States 12006
    24 Ruth Oratz MD New York New York United States 10016
    25 Interlakes Oncology Hematology, PC Rochester New York United States 14623
    26 Cancer Centers of North Carolina Raleigh North Carolina United States 27607
    27 Greater Dayton Cancer Center Kettering Ohio United States 45409
    28 Willamette Valley Cancer Center Eugene Oregon United States 97401
    29 Medical Oncology Associates Kingston Pennsylvania United States 18704
    30 Cancer Centers of the Carolinas Greenville South Carolina United States 29605
    31 Texas Cancer Center-Abilene (South) Abilene Texas United States 79606
    32 Texas Oncology, P.A.-Amarillo Amarillo Texas United States 79106
    33 Texas Cancer Center Arlington Texas United States 76014
    34 Texas Oncology Cancer Center Austin Texas United States 78731
    35 Mamie McFaddin Ward Cancer Center Beaumont Texas United States 77702
    36 Texas Oncology, P.A.-Bedford Bedford Texas United States 76022
    37 Texas Cancer Center at Medical City Dallas Texas United States 75230
    38 Texas Oncology, P.A. Dallas Texas United States 75231
    39 Methodist Charlton Cancer Ctr. Dallas Texas United States 75237
    40 Texas Oncology, P.A. Dallas Texas United States 75246
    41 Texas Cancer Center Denton Texas United States 76210
    42 El Paso Cancer Treatment Ctr EL Paso Texas United States 79915
    43 Texas Oncology, P.A. Fort Worth Texas United States 76104
    44 Texas Oncology, P.A. Garland Texas United States 75042
    45 Texas Oncology, P.A. Houston Texas United States 77024
    46 Lake Vista Cancer Center Lewisville Texas United States 75067
    47 Longview Cancer Center Longview Texas United States 75601
    48 South Texas Cancer Center-McAllen McAllen Texas United States 78503
    49 Texas Cancer Center of Mesquite Mesquite Texas United States 75150
    50 Allison Cancer Center Midland Texas United States 79701
    51 Texas Oncology-Odessa Odessa Texas United States 79761
    52 Paris Regional Cancer Center Paris Texas United States 75460
    53 San Antonio Tumor and Blood Clinic San Antonio Texas United States 78217
    54 HOAST-Medical Dr. San Antonio Texas United States 78229
    55 Texas Cancer Center-Sherman Sherman Texas United States 75090
    56 Texas Oncology Cancer Center-Sugar Land Sugar Land Texas United States 77479
    57 Tyler Cancer Center Tyler Texas United States 75702
    58 Texas Oncology Cancer Care and Research Waco Texas United States 76712
    59 Texas Oncology PA Webster Texas United States 77598
    60 Texoma Cancer Center Wichita Falls Texas United States 76310
    61 Fairfax Northern VA Hem-Onc PC Fairfax Virginia United States 22031
    62 Virginia Oncology Associates Norfolk Virginia United States 23502
    63 Onc and Hem Associates of SW VA, Inc. Salem Virginia United States 24153
    64 Highline Medical Oncology Burien Washington United States 98166
    65 Puget Sound Cancer Center-Edmonds Edmonds Washington United States 98026
    66 Puget Sound Cancer Center-Seattle Seattle Washington United States 98133
    67 Cancer Care Northwest-South Spokane Washington United States 99202
    68 Northwest Cancer Specialists-Vancouver Vancouver Washington United States 98684
    69 Yakima Valley Mem Hosp/North Star Lodge Yakima Washington United States 98902

    Sponsors and Collaborators

    • US Oncology Research
    • Sanofi

    Investigators

    • Principal Investigator: Stephen E Jones, MD, US Oncology Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    US Oncology Research
    ClinicalTrials.gov Identifier:
    NCT00493649
    Other Study ID Numbers:
    • 06-038
    • 11270
    First Posted:
    Jun 28, 2007
    Last Update Posted:
    Nov 3, 2016
    Last Verified:
    Sep 1, 2016
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title TC+H
    Arm/Group Description This is a nonrandomized, noncomparative, open-label Phase II study. On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive docetaxel (Taxotere) 75 mg/m^2 IV plus cyclophosphamide (Cytoxan) 600 mg/m^2 IV, plus weekly trastuzumab (Herceptin) 4 mg/kg IV (loading dose, Day 1, Cycle 1 only) and 2 mg/kg IV (on Days 1, 8, and 15) thereafter. Subsequent cycles of therapy will continue until a total of 4 cycles of TC+H have been completed. Then, patients will continue to receive trastuzumab 6 mg/kg every 3 weeks to complete 1 year of anti-HER2 therapy as per the current standard of care.
    Period Title: Overall Study
    STARTED 493
    COMPLETED 411
    NOT COMPLETED 82

    Baseline Characteristics

    Arm/Group Title TC+H
    Arm/Group Description docetaxel (Taxotere), plus cyclophosphamide (Cytoxan), plus weekly trastuzumab (Herceptin)
    Overall Participants 493
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    55.1
    (10.1)
    Sex: Female, Male (Count of Participants)
    Female
    493
    100%
    Male
    0
    0%
    Race/Ethnicity, Customized (participants) [Number]
    Caucasian
    414
    84%
    Black
    36
    7.3%
    Hispanic
    27
    5.5%
    Asian
    12
    2.4%
    Indian
    1
    0.2%
    Other
    3
    0.6%
    Region of Enrollment (participants) [Number]
    United States
    493
    100%

    Outcome Measures

    1. Primary Outcome
    Title Disease-free Survival (DFS) Rate at 2 Years in TOP2A-amplified and in TOP2A-nonamplified HER2+ ESBC Patients Treated With TC+H.
    Description DFS was measured from the date of registration to either the date the patient was first recorded as having disease recurrence, or the date of death due to any causes before recurrence. If a patient had not recurred or died, DFS was censored at the date of last follow-up.
    Time Frame 2 years

    Outcome Measure Data

    Analysis Population Description
    ITT population. Patients were excluded if their TOP2A amplification were unknown.
    Arm/Group Title TOP2A-amplified Group TOP2A-nonamplified Group
    Arm/Group Description FISH ratio of TOP2A gene copy number was 2 or greater. FISH ratio of TOP2A gene copy number was less than 2.
    Measure Participants 190 248
    Number (95% Confidence Interval) [probability of disease-free survival]
    0.978
    0.979
    2. Secondary Outcome
    Title Overall Survival (OS) Rate at 2 Years in TOP2A-amplified and in TOP2A-nonamplified HER2+ ESBC Patients Treated With TC+H.
    Description OS is measured from the date of registration to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.
    Time Frame 2 years

    Outcome Measure Data

    Analysis Population Description
    ITT population. Patients were excluded if their TOP2A amplification were unknown.
    Arm/Group Title TOP2A-amplified Group TOP2A-nonamplified Group
    Arm/Group Description FISH ratio of TOP2A gene copy number was 2 or greater. FISH ratio of TOP2A gene copy number was less than 2.
    Measure Participants 190 248
    Number (95% Confidence Interval) [probability of overall survival]
    0.995
    0.988
    3. Secondary Outcome
    Title DFS by cMyc Expression in This Population of HER2+ ESBC Patients Treated With TC+H.
    Description DFS was measured from the date of registration to either the date the patient was first recorded as having disease recurrence, or the date of death due to any causes before recurrence. If a patient had not recurred or died, DFS was censored at the date of last follow-up.
    Time Frame 2 years

    Outcome Measure Data

    Analysis Population Description
    ITT population. Patients were excluded if their cMYC amplification were unknown.
    Arm/Group Title cMYC-amplified Group cMYC-nonamplified Group
    Arm/Group Description FISH ratio of cMYC gene copy number was 2 or greater. FISH ratio of cMYC gene copy number was less than 2.
    Measure Participants 99 337
    Number (95% Confidence Interval) [probability of disease-free survival]
    0.968
    0.981
    4. Secondary Outcome
    Title OS by cMyc Expression in This Population of HER2+ ESBC Patients Treated With TC+H.
    Description OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.
    Time Frame 2 years

    Outcome Measure Data

    Analysis Population Description
    ITT population. Patients were excluded if their cMYC amplification were unknown.
    Arm/Group Title cMYC-amplified Group cMYC-nonamplified Group
    Arm/Group Description FISH ratio of cMYC gene copy number was 2 or greater. FISH ratio of cMYC gene copy number was less than 2.
    Measure Participants 99 337
    Number (95% Confidence Interval) [probability of overall survival]
    0.990
    0.991

    Adverse Events

    Time Frame During the whole treatment period, up to 30 days following last dose.
    Adverse Event Reporting Description For treated patients only, assessed at each treatment visit.
    Arm/Group Title TC+H
    Arm/Group Description docetaxel (Taxotere), plus cyclophosphamide (Cytoxan), plus weekly trastuzumab (Herceptin)
    All Cause Mortality
    TC+H
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    TC+H
    Affected / at Risk (%) # Events
    Total 51/486 (10.5%)
    Blood and lymphatic system disorders
    ANEMIA 1/486 (0.2%) 1
    NEUTROPENIA 4/486 (0.8%) 5
    Cardiac disorders
    FIBRILLATION ATRIAL 1/486 (0.2%) 1
    Gastrointestinal disorders
    ABDOMINAL PAIN 2/486 (0.4%) 2
    BLOATING 1/486 (0.2%) 1
    BOWEL PERFORATION 1/486 (0.2%) 1
    COLITIS 1/486 (0.2%) 1
    DEHYDRATION 5/486 (1%) 6
    DIARRHEA 5/486 (1%) 5
    GASTRIC INFLAMMATION 1/486 (0.2%) 1
    NAUSEA 3/486 (0.6%) 3
    NAUSEA AND VOMITING 1/486 (0.2%) 1
    VOMITING 1/486 (0.2%) 1
    General disorders
    FEVER 5/486 (1%) 5
    PAIN 1/486 (0.2%) 1
    Hepatobiliary disorders
    HEPATIC ENZYMES INCREASED 1/486 (0.2%) 1
    LIVER FUNCTION TESTS MULTIPLE ABNORM 1/486 (0.2%) 1
    Infections and infestations
    CELLULITIS 4/486 (0.8%) 4
    CELLULITIS BREAST 1/486 (0.2%) 1
    DIVERTICULITIS 1/486 (0.2%) 1
    FEBRILE NEUTROPENIA 22/486 (4.5%) 23
    INFECTION 1/486 (0.2%) 1
    MASTITIS 1/486 (0.2%) 1
    MUCOSITIS NOS 1/486 (0.2%) 1
    Metabolism and nutrition disorders
    HYPOKALEMIA 1/486 (0.2%) 1
    Nervous system disorders
    HYPERSENSITIVITY REACTION (NOS) 1/486 (0.2%) 1
    SHOCK 1/486 (0.2%) 1
    SYNCOPE 2/486 (0.4%) 2
    Respiratory, thoracic and mediastinal disorders
    ASPIRATION 1/486 (0.2%) 1
    LUNG FIBROSIS INTERSTITIAL 1/486 (0.2%) 1
    PNEUMONIA 3/486 (0.6%) 3
    PULMONARY INFILTRATION 1/486 (0.2%) 1
    SHORTNESS OF BREATH 1/486 (0.2%) 1
    Vascular disorders
    THROMBOSIS ARTERIAL LEG 1/486 (0.2%) 1
    Other (Not Including Serious) Adverse Events
    TC+H
    Affected / at Risk (%) # Events
    Total 481/486 (99%)
    Blood and lymphatic system disorders
    ANEMIA 131/486 (27%) 227
    EDEMA 86/486 (17.7%) 120
    LEUCOPENIA 84/486 (17.3%) 179
    NEUTROPENIA 247/486 (50.8%) 597
    Cardiac disorders
    CARDIAC INSUFFICIENCY 29/486 (6%) 34
    Gastrointestinal disorders
    ANOREXIA 56/486 (11.5%) 69
    CONSTIPATION 90/486 (18.5%) 112
    DIARRHEA 183/486 (37.7%) 276
    DYSGUESIA 73/486 (15%) 86
    GASTROESOPHAGEAL REFLUX 63/486 (13%) 68
    NAUSEA 216/486 (44.4%) 315
    VOMITING 45/486 (9.3%) 53
    General disorders
    FATIGUE 284/486 (58.4%) 487
    FEVER 42/486 (8.6%) 55
    HEADACHE 55/486 (11.3%) 67
    HOT FLASHES 50/486 (10.3%) 59
    INSOMNIA 49/486 (10.1%) 61
    PAIN 64/486 (13.2%) 91
    Infections and infestations
    MUCOSITIS 89/486 (18.3%) 115
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA 66/486 (13.6%) 77
    MYALGIA 81/486 (16.7%) 96
    Nervous system disorders
    NEUROPATHY 99/486 (20.4%) 125
    Respiratory, thoracic and mediastinal disorders
    SHORTNESS OF BREATH 41/486 (8.4%) 46
    Skin and subcutaneous tissue disorders
    ALOPECIA 339/486 (69.8%) 395
    MUCOSAL 32/486 (6.6%) 39
    NAIL DISORDER 34/486 (7%) 38
    RASH 104/486 (21.4%) 141

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Stephen E Jones
    Organization US Oncology Research, McKesson Specialty Health
    Phone 832-381-7580
    Email steve.jones@usoncology.com
    Responsible Party:
    US Oncology Research
    ClinicalTrials.gov Identifier:
    NCT00493649
    Other Study ID Numbers:
    • 06-038
    • 11270
    First Posted:
    Jun 28, 2007
    Last Update Posted:
    Nov 3, 2016
    Last Verified:
    Sep 1, 2016