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Carboplatin and Combination Chemotherapy With or Without Veliparib in Treating Patients With Stage IIB-IIIC Breast Cancer

Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University (Other)
Overall Status
Completed
CT.gov ID
NCT01818063
Collaborator
Susan G. Komen Breast Cancer Foundation (Other)
9
Enrollment
3
Locations
2
Arms
67.5
Actual Duration (Months)
3
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This randomized phase II trial studies how well carboplatin and combination chemotherapy with or without veliparib works in treating patients with stage IIB-IIIC breast cancer. Drugs used in chemotherapy, such as paclitaxel, carboplatin, doxorubicin hydrochloride, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving carboplatin and combination chemotherapy are more effective with or without veliparib is more effective in treating breast cancer.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

PRIMARY OBJECTIVE:
  1. To compare the pathologic complete response (path CR) in patients with stage IIB or stage III triple negative breast cancer treated with neoadjuvant paclitaxel and carboplatin to the path CR of patients treated with paclitaxel, carboplatin, and veliparib.
SECONDARY OBJECTIVES:

  1. Relapse free survival (follow-up period of 36 months).

  2. Overall clinical response to neoadjuvant therapy.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive paclitaxel intravenously (IV) and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive veliparib orally (PO) twice daily (BID) on days 1-5. Patients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 36 months.

Study Design

Study Type:
Interventional
Actual Enrollment :
9 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Adaptive, Randomized Phase II Trial to Determine Pathologic Complete Response With the Addition of Carboplatin With and Without Veliparib to Standard Chemotherapy in the Neoadjuvant Treatment of Triple-Negative Breast Cancer
Actual Study Start Date :
Apr 25, 2013
Actual Primary Completion Date :
Mar 1, 2015
Actual Study Completion Date :
Dec 10, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1 (paclitaxel, carboplatin)

Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Drug: Paclitaxel
Given IV
Other Names:
  • Taxol
  • Abraxane

    • Drug: Carboplatin
    Given IV
    Other Names:
  • cis-Diammine(1,1-cyclobutanedicarboxylato)platinum(II)
  • Paraplatin
  • Paraplatin-AQ

    • Drug: Doxorubicin
    Given IV
    Other Names:
  • Adriamycin
  • hydroxydaunorubicin
  • Adriamycin PFS
  • Adriamycin RDF
  • Rubex
  • Doxil

    • Drug: Cyclophosphamide
    Given IV
    Other Names:
  • Endoxan
  • Cytoxan
  • Neosar
  • Procytox
  • Revimmune
  • cytophosphane
  • Lyophilizedcytoxan

    		•
    Experimental: Arm 2 (veliparib, paclitaxel, carboplatin)

    Patients receive veliparib PO BID on days 1-5. Patients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

    Drug: Paclitaxel
    Given IV
    Other Names:
  • Taxol
  • Abraxane

    • Drug: Carboplatin
    Given IV
    Other Names:
  • cis-Diammine(1,1-cyclobutanedicarboxylato)platinum(II)
  • Paraplatin
  • Paraplatin-AQ

    • Drug: Doxorubicin
    Given IV
    Other Names:
  • Adriamycin
  • hydroxydaunorubicin
  • Adriamycin PFS
  • Adriamycin RDF
  • Rubex
  • Doxil

    • Drug: Cyclophosphamide
    Given IV
    Other Names:
  • Endoxan
  • Cytoxan
  • Neosar
  • Procytox
  • Revimmune
  • cytophosphane
  • Lyophilizedcytoxan

    • Drug: Veliparib
    Given PO
    Other Names:
  • ABT-888

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Count of Participants That Achieve Pathologic Complete Response (PCR) [36 months following surgery]

      PCR is defined as the absence of any residual invasive cancer on hematoxylin and eosin (H&E) evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes.

    Secondary Outcome Measures

    1. Overall Clinical Response [Up to 3 years]

      The count and percentage of subjects with each category of overall clinical response will be summarized by presence of baseline measureable disease (i.e., complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD], unable to evaluate [UE], neurogenerative disease [ND]). Evaluated per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) as assessed b MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Beta will be used as priors for combination regimens in calculating the posterior distribution of the pathologic complete response [pCR] for each respective treatment group. Among subjects with measurable disease, a 95% credible region will be calculated for the odds ratio for each treatment combination relative to each other.

    2. Relapse Free Survival [Up to 3 years]

      Analyzed using Kaplan-Meier methods, stratified by study group, and the log rank test will be completed.

    Eligibility Criteria

    Criteria

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

    1. Written informed consent must be obtained prior to any study-related procedures.

    2. Histologically confirmed adenocarcinoma of the breast with the following markers: Estrogen receptor negative (<1%), progesterone receptor negative (<1%), and Her-2/neu negative (Her-2/neu 0-1+ IHC or FISH ratio <1.8 or average HER2 gene copy number of <four signal/nucleus for test systems without internal control probe).

    3. Female ≥ 18 years old.

    4. Clinical stage IIA (T2N0), IIB (T2N1, T3N0) or stage IIIA (T1N2, T2N2, T3N1, T3N2), IIIB, or IIIC breast cancer with no prior treatment.

    5. Complete radiology or tumor assessment within 28 days prior to enrollment

    6. Breast MRI

    7. Unilateral Breast Ultrasound

    8. Distant metastatic work-up completed with PET/CT.

    9. If enlarged axillary lymph nodes are found during staging scans, FNA must be performed to determine whether the node is involved with cancer.

    10. If axillary lymph nodes are clinically negative during initial work-up, sentinel node biopsy will be performed prior to initiation of chemotherapy.

    11. ECOG Performance Status of 0 or 1

    12. Adequate organ and hematologic function as evidenced by the following laboratory studies within 4 weeks of study enrollment:

    13. Cardiac Ejection Fraction >/= lower limit of normal as determined by 2-D echo or MUGA scan according to institutional standards.

    14. Hematologic function, as follows: Absolute neutrophil count ≥ 1.5 x 109/L, Platelet count ≥ 100 x 109/L and ≤ 850 x 109/L, Hemoglobin ≥ 9 g/dL, PTT and INR < 1.5 x ULN.

    15. Renal function, as follows: Serum creatinine </= 1.4 mg/dL).

    16. Hepatic function, as follows:Aspartate aminotransferase (AST) ≤ 2.5 x ULN, Alanine aminotransferase (ALT) ≤ 2.5 x ULN , Total bilirubin ≤ 2 x ULN (except for patients with UGT1A1 promoter polymorphism, i.e. Gilbert syndrome, confirmed by genotyping or Invader UGT1A1 molecular assay prior to study enrollment. Patients enrolled with Gilbert syndrome must have total bilirubin < 3 ULN).

    17. Patient must be willing and able to undergo MRI as outlined in protocol.

    Exclusion Criteria:

    1. Known hypersensitivity to doxorubicin, cyclophosphamide, paclitaxel, cremophor or medications containing cremophor(miconazole, docetaxel, sandimmune, nelfinavir mesylate, propofol, diazepam injection, vitamin K injection, ixabepilone, aci-jel) or carboplatin.

    2. Known HIV or active Hepatitis B or C infection.

    3. Prior treatment for the currently diagnosed breast cancer.

    4. Prior treatment with doxorubicin up to 400 mg/m2.

    5. Pre-existing Grade 3 or 4 sensory neuropathy.

    6. History of bleeding diathesis or extensive bleeding requiring blood transfusion within 14 days of enrollment.

    7. Major surgical procedure within 4 weeks (28 days) prior to enrollment (port placement is not considered a major surgical procedure).

    8. Clinically significant cardiac disease within 12 months of study enrollment, including myocardial infarction, unstable angina, congestive heart failure, or ongoing arrhythmias requiring medication or pacemaker.

    9. Non-healing wound, ulcer or fracture.

    10. Ongoing or active infection.

    11. Pregnant (i.e., positive beta-human chorionic gonadotropin test) or lactating

    12. Not willing to use a highly effective method of birth control (i.e. those which result in low failure rates, less than 1% per year), defined as intrauterine devices, barrier methods (condoms, contraceptive sponges, diaphragms, vaginal rings used with spermicidal jellies or creams), oral contraceptive pills, or sexual abstinence. Contraception must be used during the study.

    13. T0 tumors

    14. Active dental infection

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Walter Reed National Military Medical Center Bethesda Maryland United States 20889
    2 Thomas Jefferson University Philadelphia Pennsylvania United States 19107
    3 Reading Hospital Reading Pennsylvania United States 19611

    Sponsors and Collaborators

    • Sidney Kimmel Cancer Center at Thomas Jefferson University
    • Susan G. Komen Breast Cancer Foundation

    Investigators

    • Principal Investigator: Edith Mitchell, MD, Thomas Jefferson University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Sidney Kimmel Cancer Center at Thomas Jefferson University
    ClinicalTrials.gov Identifier:
    NCT01818063
    Other Study ID Numbers:
    • 12G.376
    • 2012-47
    First Posted:
    Mar 26, 2013
    Last Update Posted:
    Oct 28, 2019
    Last Verified:
    Oct 1, 2019
    Additional relevant MeSH terms:
    Breast Neoplasms
    Triple Negative Breast Neoplasms
    Paclitaxel
    Cyclophosphamide
    Carboplatin
    Doxorubicin
    Liposomal doxorubicin
    Veliparib

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Arm 1 (Paclitaxel, Carboplatin) Arm 2 (Veliparib, Paclitaxel, Carboplatin)
    Arm/Group Description Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Paclitaxel: Given IV Carboplatin: Given IV Doxorubicin: Given IV Cyclophosphamide: Given IV Patients receive veliparib PO BID on days 1-5. Patients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Paclitaxel: Given IV Carboplatin: Given IV Doxorubicin: Given IV Cyclophosphamide: Given IV Veliparib: Given PO
    Period Title: Overall Study
    STARTED 5 4
    COMPLETED 5 4
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title Arm 1 (Paclitaxel, Carboplatin) Arm 2 (Veliparib, Paclitaxel, Carboplatin) Total
    Arm/Group Description Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Paclitaxel: Given IV Carboplatin: Given IV Doxorubicin: Given IV Cyclophosphamide: Given IV Patients receive veliparib PO BID on days 1-5. Patients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Paclitaxel: Given IV Carboplatin: Given IV Doxorubicin: Given IV Cyclophosphamide: Given IV Veliparib: Given PO Total of all reporting groups
    Overall Participants 5 4 9
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    3
    60%
    4
    100%
    7
    77.8%
    >=65 years
    2
    40%
    0
    0%
    2
    22.2%
    Sex: Female, Male (Count of Participants)
    Female
    5
    100%
    4
    100%
    9
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    1
    25%
    1
    11.1%
    Not Hispanic or Latino
    5
    100%
    3
    75%
    8
    88.9%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    1
    20%
    2
    50%
    3
    33.3%
    White
    4
    80%
    2
    50%
    6
    66.7%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (Count of Participants)
    United States
    5
    100%
    4
    100%
    9
    100%

    Outcome Measures

    1. Primary Outcome
    Title Count of Participants That Achieve Pathologic Complete Response (PCR)
    Description PCR is defined as the absence of any residual invasive cancer on hematoxylin and eosin (H&E) evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes.
    Time Frame 36 months following surgery

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Arm 1 (Paclitaxel, Carboplatin) Arm 2 (Veliparib, Paclitaxel, Carboplatin)
    Arm/Group Description Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Paclitaxel: Given IV Carboplatin: Given IV Doxorubicin: Given IV Cyclophosphamide: Given IV Patients receive veliparib PO BID on days 1-5. Patients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Paclitaxel: Given IV Carboplatin: Given IV Doxorubicin: Given IV Cyclophosphamide: Given IV Veliparib: Given PO
    Measure Participants 5 4
    Count of Participants [Participants]
    3
    60%
    3
    75%
    2. Secondary Outcome
    Title Overall Clinical Response
    Description The count and percentage of subjects with each category of overall clinical response will be summarized by presence of baseline measureable disease (i.e., complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD], unable to evaluate [UE], neurogenerative disease [ND]). Evaluated per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) as assessed b MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Beta will be used as priors for combination regimens in calculating the posterior distribution of the pathologic complete response [pCR] for each respective treatment group. Among subjects with measurable disease, a 95% credible region will be calculated for the odds ratio for each treatment combination relative to each other.
    Time Frame Up to 3 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Arm 1 (Paclitaxel, Carboplatin) Arm 2 (Veliparib, Paclitaxel, Carboplatin)
    Arm/Group Description Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Paclitaxel: Given IV Carboplatin: Given IV Doxorubicin: Given IV Cyclophosphamide: Given IV Patients receive veliparib PO BID on days 1-5. Patients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Paclitaxel: Given IV Carboplatin: Given IV Doxorubicin: Given IV Cyclophosphamide: Given IV Veliparib: Given PO
    Measure Participants 5 4
    Progressive Disease
    1
    20%
    1
    25%
    Partial Response
    2
    40%
    1
    25%
    Pathological Complete Response
    2
    40%
    2
    50%
    3. Secondary Outcome
    Title Relapse Free Survival
    Description Analyzed using Kaplan-Meier methods, stratified by study group, and the log rank test will be completed.
    Time Frame Up to 3 years

    Outcome Measure Data

    Analysis Population Description
    Sincere efforts have been made to gather and report the data, however, no data is available for this outcome measure.
    Arm/Group Title Arm 1 (Paclitaxel, Carboplatin) Arm 2 (Veliparib, Paclitaxel, Carboplatin)
    Arm/Group Description Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Paclitaxel: Given IV Carboplatin: Given IV Doxorubicin: Given IV Cyclophosphamide: Given IV Patients receive veliparib PO BID on days 1-5. Patients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Paclitaxel: Given IV Carboplatin: Given IV Doxorubicin: Given IV Cyclophosphamide: Given IV Veliparib: Given PO
    Measure Participants 0 0

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Arm 1 (Paclitaxel, Carboplatin) Arm 2 (Veliparib, Paclitaxel, Carboplatin)
    Arm/Group Description Patients receive paclitaxel IV and carboplatin IV on day 1 (course 1 only) or day 2 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Paclitaxel: Given IV Carboplatin: Given IV Doxorubicin: Given IV Cyclophosphamide: Given IV Patients receive veliparib PO BID on days 1-5. Patients also receive paclitaxel IV and carboplatin IV on day 3 (course 1 only) or day 4 (courses 2-12). Treatment repeats every 7 days for 12 courses in the absence of disease progression or unacceptable toxicity. Beginning 21 days after the last course, patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Paclitaxel: Given IV Carboplatin: Given IV Doxorubicin: Given IV Cyclophosphamide: Given IV Veliparib: Given PO
    All Cause Mortality
    Arm 1 (Paclitaxel, Carboplatin) Arm 2 (Veliparib, Paclitaxel, Carboplatin)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/5 (0%) 0/4 (0%)
    Serious Adverse Events
    Arm 1 (Paclitaxel, Carboplatin) Arm 2 (Veliparib, Paclitaxel, Carboplatin)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/5 (20%) 0/4 (0%)
    Infections and infestations
    Viral Meningitis 1/5 (20%) 1 0/4 (0%) 0
    Other (Not Including Serious) Adverse Events
    Arm 1 (Paclitaxel, Carboplatin) Arm 2 (Veliparib, Paclitaxel, Carboplatin)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 3/5 (60%) 1/4 (25%)
    Blood and lymphatic system disorders
    Alkaline phosphatase Increased 1/5 (20%) 7 1/4 (25%) 1
    ALT Increase 1/5 (20%) 1 1/4 (25%) 1
    Anemia 2/5 (40%) 2 1/4 (25%) 1
    Hyperglycemia 1/5 (20%) 2 0/4 (0%) 0
    Hypoglycemia 1/5 (20%) 2 0/4 (0%) 0
    Platelet Count decreased 1/5 (20%) 1 1/4 (25%) 1
    Gastrointestinal disorders
    Constipation 1/5 (20%) 1 0/4 (0%) 0
    Diarrhea 2/5 (40%) 2 0/4 (0%) 0
    Diverticulitis 1/5 (20%) 1 0/4 (0%) 0
    Laryngeal Inflammation 0/5 (0%) 0 1/4 (25%) 1
    Mucositis 0/5 (0%) 0 1/4 (25%) 2
    Nausea 1/5 (20%) 2 1/4 (25%) 2
    Vomiting 1/5 (20%) 1 0/4 (0%) 0
    General disorders
    Bone Pain 2/5 (40%) 7 0/4 (0%) 0
    Dehydration 1/5 (20%) 2 1/4 (25%) 1
    Dizziness 1/5 (20%) 1 0/4 (0%) 0
    Fall 2/5 (40%) 2 1/4 (25%) 1
    Fatigue 1/5 (20%) 1 0/4 (0%) 0
    Flu like symptoms 2/5 (40%) 3 1/4 (25%) 2
    Hot flashes 1/5 (20%) 1 0/4 (0%) 0
    Night Sweats 0/5 (0%) 0 1/4 (25%) 1
    Pain 0/5 (0%) 0 1/4 (25%) 1
    Runny nose 0/5 (0%) 0 1/4 (25%) 1
    Scalp pain 1/5 (20%) 1 0/4 (0%) 0
    Voice alteration 1/5 (20%) 1 0/4 (0%) 0
    Infections and infestations
    Infection UTI 1/5 (20%) 1 0/4 (0%) 0
    Injury, poisoning and procedural complications
    Head Injury 2/5 (40%) 3 1/4 (25%) 1
    Nervous system disorders
    Insomnia 1/5 (20%) 1 1/4 (25%) 2
    Neuropathy 0/5 (0%) 0 1/4 (25%) 1
    Paresthesia 0/5 (0%) 0 1/4 (25%) 1
    Sciatica 1/5 (20%) 1 0/4 (0%) 0
    Psychiatric disorders
    Anxiety 1/5 (20%) 1 0/4 (0%) 0
    Psychiatric Disorders, mood 0/5 (0%) 0 1/4 (25%) 1
    Renal and urinary disorders
    Urinary Urgency 1/5 (20%) 1 0/4 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Cough 1/5 (20%) 2 0/4 (0%) 0
    Dyspnea 1/5 (20%) 1 0/4 (0%) 0
    Skin and subcutaneous tissue disorders
    Alopecia 2/5 (40%) 2 1/4 (25%) 1
    Burn 2/5 (40%) 7 0/4 (0%) 0
    Rash Acneiform 0/5 (0%) 0 1/4 (25%) 1
    Rash Maculopapular 1/5 (20%) 1 1/4 (25%) 1
    Scratch 1/5 (20%) 1 0/4 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE 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. Edith Mitchell
    Organization Sidney Kimmel Cancer Center at Thomas Jefferson University
    Phone 215-955-8874
    Email edith.mitchell@jefferson.edu
    Responsible Party:
    Sidney Kimmel Cancer Center at Thomas Jefferson University
    ClinicalTrials.gov Identifier:
    NCT01818063
    Other Study ID Numbers:
    • 12G.376
    • 2012-47
    First Posted:
    Mar 26, 2013
    Last Update Posted:
    Oct 28, 2019
    Last Verified:
    Oct 1, 2019