Ixabepilone in Treating Patients With Recurrent or Persistent Endometrial Cancer

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00095979
Collaborator
Gynecologic Oncology Group (Other)
52
Enrollment
1
Location
1
Arm
50
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well ixabepilone works in treating patients with recurrent or persistent endometrial cancer.

Detailed Description

PRIMARY OBJECTIVES:
  1. Determine the response rate in patients with recurrent or persistent endometrial adenocarcinoma treated with ixabepilone.

  2. Determine the nature and degree of toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 2.5 years.

Study Design

Study Type:
Interventional
Actual Enrollment :
52 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Evaluation of Ixabepilone (BMS-247550) [NCI-Supplied Agent, NSC #710428]) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
Study Start Date :
May 1, 2005
Actual Primary Completion Date :
Jul 1, 2009
Actual Study Completion Date :
Jul 1, 2009

Arms and Interventions

ArmIntervention/Treatment
Experimental: Treatment (ixabepilone)

Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: ixabepilone
Given IV
Other Names:
  • BMS-247550
  • epothilone B lactam
  • Ixempra
  • Outcome Measures

    Primary Outcome Measures

    1. Tumor Response [Every other cycle for first 6 months; then every six months thereafter until completion of study treatment; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease]

      RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.

    2. Frequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3) [Every cycle until completion of study treatment up to 30 days after stopping study treatment (average length of data collection = 4 months)]

    Secondary Outcome Measures

    1. Progression-free Survival [From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up.]

      Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.

    2. Overall Survival [From study entry to death or last contact, up to 5 years of follow-up.]

      Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Histologically confirmed endometrial adenocarcinoma

    • Recurrent or persistent disease

    • Histologic confirmation of the original primary tumor is required

    • Not amenable to management with any of the following:

    • Surgery

    • Radiotherapy

    • Higher priority or standard chemotherapy

    • Measurable disease

    • At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR ≥ 10 mm by spiral CT scan

    • At least 1 target lesion

    • Tumors within a previously irradiated field are designated as non-target lesions

    • Disease in an irradiated field as the only site of measurable disease is acceptable as a target lesion only if there has been clear progression of the lesion at least 90 days after completion of radiotherapy

    • Received 1, and only 1, prior chemotherapy regimen (e.g., high-dose therapy, consolidation, or extended therapy administered after surgery or non-surgical assessment) for management of endometrial adenocarcinoma

    • Ineligible for a higher priority Gynecologic Oncology Group (GOG) protocol (e.g., any active GOG phase III study for the same patient population)

    • Performance status - GOG 0-2

    • Absolute neutrophil count ≥ 1,500/mm^3

    • Platelet count ≥ 100,000/mm^3

    • Bilirubin ≤ 1.5 times upper limit of normal (ULN)

    • AST (aspartate aminotransferase) ≤ 2.5 times ULN

    • Alkaline phosphatase ≤ 2.5 times ULN

    • Creatinine ≤ 1.5 times ULN

    • Sensory or motor neuropathy ≤ grade 1

    • Not pregnant or nursing

    • Negative pregnancy test

    • Fertile patients must use effective contraception

    • No active infection requiring antibiotics

    • No other invasive malignancies within the past 5 years except non-melanoma skin cancer

    • At least 3 weeks since prior biologic or immunologic agents directed at the malignant tumor

    • One prior non-cytotoxic* (biologic or cytostatic) regimen for management of recurrent or persistent disease allowed

    • See Disease Characteristics

    • Prior paclitaxel or docetaxel allowed

    • Recovered from prior chemotherapy

    • No more than 1 prior cytotoxic chemotherapy regimen (either single or combination drug therapy)

    • No prior ixabepilone

    • At least 1 week since prior hormonal therapy directed at the malignant tumor

    • Continuation of hormone replacement therapy allowed

    • See Disease Characteristics

    • Recovered from prior radiotherapy

    • Recovered from prior surgery

    • At least 3 weeks since other prior therapy directed at the malignant tumor

    • No prior cancer treatment that contraindicates study therapy

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Gynecologic Oncology GroupPhiladelphiaPennsylvaniaUnited States19103

    Sponsors and Collaborators

    • National Cancer Institute (NCI)
    • Gynecologic Oncology Group

    Investigators

    • Principal Investigator: Don Dizon, Gynecologic Oncology Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00095979
    Other Study ID Numbers:
    • NCI-2012-02628
    • NCI-2012-02628
    • CDR0000391849
    • GOG-0129P
    • GOG-0129P
    • U10CA027469
    First Posted:
    Nov 9, 2004
    Last Update Posted:
    Jul 24, 2019
    Last Verified:
    Jul 1, 2019

    Study Results

    Participant Flow

    Recruitment DetailsThe study was activated on 5/2/2005 and closed to accrual on 1/3/2008 (suspended from 4/3/2006 to 4/1/2007).
    Pre-assignment Detail
    Arm/Group TitleIxabepilone
    Arm/Group DescriptionIxabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
    Period Title: Overall Study
    STARTED52
    COMPLETED50
    NOT COMPLETED2

    Baseline Characteristics

    Arm/Group TitleIxabepilone
    Arm/Group DescriptionIxabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
    Overall Participants50
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    64.8
    (9.4)
    Age, Customized (participants) [Number]
    20-29 years
    0
    0%
    30-39 years
    0
    0%
    40-49 years
    2
    4%
    50-59 years
    11
    22%
    60-69 years
    19
    38%
    70-79 years
    16
    32%
    80-89 years
    2
    4%
    Sex: Female, Male (Count of Participants)
    Female
    50
    100%
    Male
    0
    0%
    International Federation of Gynecology and Obstetrics (FIGO) Stage Recurrent/Persistent (participants) [Number]
    Number [participants]
    50
    100%
    Histologic Type (participants) [Number]
    Adenocarcinoma, Unspecified
    1
    2%
    Clear Cell Carcinoma
    1
    2%
    Endometrioid Adenocarcinoma
    22
    44%
    Mixed Epithelial Carcinoma
    4
    8%
    Serous Adenocarcinoma
    21
    42%
    Carcinosarcoma-homologous
    1
    2%

    Outcome Measures

    1. Primary Outcome
    TitleTumor Response
    DescriptionRECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
    Time FrameEvery other cycle for first 6 months; then every six months thereafter until completion of study treatment; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease

    Outcome Measure Data

    Analysis Population Description
    Eligible and Treated Patients
    Arm/Group TitleIxabepilone
    Arm/Group DescriptionIxabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
    Measure Participants50
    Number (90% Confidence Interval) [percentage of participants]
    12
    24%
    2. Primary Outcome
    TitleFrequency and Severity of Observed Adverse Effects Associated With Protocol Therapy (CTCAE Version 3)
    Description
    Time FrameEvery cycle until completion of study treatment up to 30 days after stopping study treatment (average length of data collection = 4 months)

    Outcome Measure Data

    Analysis Population Description
    Eligible and treated patients
    Arm/Group TitleGrade 1Grade 2Grade 3Grade 4Grade 5
    Arm/Group DescriptionNumber of patients who experienced a grade 1 event using Common Terminology Criteria for Adverse Events (CTCAE version 3).Number of patients who experienced a grade 2 event using Common Terminology Criteria for Adverse Events (CTCAE version 3).Number of patients who experienced a grade 3 event using Common Terminology Criteria for Adverse Events (CTCAE version 3).Number of patients who experienced a grade 4 event using Common Terminology Criteria for Adverse Events (CTCAE version 3).Number of patients who experienced a grade 5 event using Common Terminology Criteria for Adverse Events (CTCAE version 3).
    Measure Participants5050505050
    Leukopenia
    9
    18%
    14
    NaN
    17
    NaN
    7
    NaN
    0
    NaN
    Neutropenia
    5
    10%
    7
    NaN
    14
    NaN
    12
    NaN
    0
    NaN
    Anemia
    12
    24%
    29
    NaN
    6
    NaN
    1
    NaN
    0
    NaN
    Thrombocytopenia
    13
    26%
    4
    NaN
    1
    NaN
    1
    NaN
    0
    NaN
    Allergy/Immunology
    4
    8%
    0
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    Auditory/ear
    0
    0%
    2
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    Cardiac
    1
    2%
    0
    NaN
    2
    NaN
    0
    NaN
    0
    NaN
    Coagulation
    0
    0%
    0
    NaN
    1
    NaN
    0
    NaN
    0
    NaN
    Constitutional
    15
    30%
    14
    NaN
    9
    NaN
    1
    NaN
    0
    NaN
    Dermatologic
    7
    14%
    21
    NaN
    2
    NaN
    0
    NaN
    0
    NaN
    Gastrointestinal
    11
    22%
    15
    NaN
    12
    NaN
    0
    NaN
    0
    NaN
    Genitourinary
    1
    2%
    1
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    Hemorrhage
    1
    2%
    1
    NaN
    2
    NaN
    0
    NaN
    0
    NaN
    Infection
    0
    0%
    2
    NaN
    8
    NaN
    0
    NaN
    0
    NaN
    Lymphatics
    8
    16%
    2
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    Metabolic
    9
    18%
    8
    NaN
    3
    NaN
    1
    NaN
    0
    NaN
    Musculoskeletal
    3
    6%
    4
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    Neurosensory
    19
    38%
    7
    NaN
    4
    NaN
    0
    NaN
    0
    NaN
    Other neurologic
    4
    8%
    3
    NaN
    4
    NaN
    1
    NaN
    0
    NaN
    Ocular/visual
    3
    6%
    3
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    Pain
    9
    18%
    8
    NaN
    3
    NaN
    0
    NaN
    0
    NaN
    Pulmonary
    10
    20%
    4
    NaN
    2
    NaN
    0
    NaN
    1
    NaN
    Alopecia
    7
    14%
    23
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    Vascular
    0
    0%
    1
    NaN
    0
    NaN
    1
    NaN
    0
    NaN
    3. Secondary Outcome
    TitleProgression-free Survival
    DescriptionProgression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
    Time FrameFrom study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up.

    Outcome Measure Data

    Analysis Population Description
    Eligible and Treated Patients
    Arm/Group TitleIxabepilone
    Arm/Group DescriptionIxabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
    Measure Participants50
    Median (95% Confidence Interval) [months]
    3.1
    4. Secondary Outcome
    TitleOverall Survival
    DescriptionOverall survival is defined as the duration of time from study entry to time of death or the date of last contact.
    Time FrameFrom study entry to death or last contact, up to 5 years of follow-up.

    Outcome Measure Data

    Analysis Population Description
    Eligible and treated patients
    Arm/Group TitleIxabepilone
    Arm/Group DescriptionIxabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
    Measure Participants50
    Median (95% Confidence Interval) [months]
    8.8

    Adverse Events

    Time FrameAll Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Average length of data collection = 4 months.
    Adverse Event Reporting Description
    Arm/Group TitleIxabepilone
    Arm/Group DescriptionIxabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
    All Cause Mortality
    Ixabepilone
    Affected / at Risk (%)# Events
    Total/ (NaN)
    Serious Adverse Events
    Ixabepilone
    Affected / at Risk (%)# Events
    Total25/50 (50%)
    Blood and lymphatic system disorders
    Neutrophils4/50 (8%)
    Hemoglobin1/50 (2%)
    Cardiac disorders
    S/N Arrhythmia: Atrial Fibrillation1/50 (2%)
    Gastrointestinal disorders
    Vomiting1/50 (2%)
    Anorexia1/50 (2%)
    Nausea3/50 (6%)
    General disorders
    Fatigue1/50 (2%)
    Death No Ctcae Term - Disease Progression Nos1/50 (2%)
    Pain: Abdominal Pain Nos2/50 (4%)
    Pain: Tumor1/50 (2%)
    Infections and infestations
    Inf W/Gr 3 Or 4 Anc: Blood1/50 (2%)
    Febrile Neutropenia2/50 (4%)
    Metabolism and nutrition disorders
    Creatinine1/50 (2%)
    Hypoalbuminemia1/50 (2%)
    Hyponatremia1/50 (2%)
    Nervous system disorders
    Syncope2/50 (4%)
    Mood Alteration - Depression1/50 (2%)
    Memory Impairment1/50 (2%)
    Dizziness1/50 (2%)
    Respiratory, thoracic and mediastinal disorders
    Hypoxia1/50 (2%)
    Vascular disorders
    Thrombosis/Thrombus/Embolism2/50 (4%)
    Other (Not Including Serious) Adverse Events
    Ixabepilone
    Affected / at Risk (%)# Events
    Total50/50 (100%)
    Blood and lymphatic system disorders
    Neutrophils36/50 (72%)
    Platelets20/50 (40%)
    Leukocytes47/50 (94%)
    Lymphopenia1/50 (2%)
    Hemoglobin48/50 (96%)
    Edema: Limb12/50 (24%)
    Cardiac disorders
    Supraventricular Tachycardia1/50 (2%)
    Ventricular Arrhythmia - Pvcs1/50 (2%)
    Hypertension2/50 (4%)
    Hypotension3/50 (6%)
    Ear and labyrinth disorders
    Hearing (Without Monitoring Program)1/50 (2%)
    Tinnitus2/50 (4%)
    Endocrine disorders
    Hot Flashes1/50 (2%)
    Diabetes1/50 (2%)
    Hypoparathyroidism1/50 (2%)
    Hyperthyroidism1/50 (2%)
    Hypothyroidism1/50 (2%)
    Eye disorders
    Ocular/Visual - Other2/50 (4%)
    Uveitis1/50 (2%)
    Watery Eye2/50 (4%)
    Dry Eye1/50 (2%)
    Flashing Lights/Floaters1/50 (2%)
    Blurred Vision5/50 (10%)
    Eyelid Dysfunction1/50 (2%)
    Gastrointestinal disorders
    Esophagitis1/50 (2%)
    Heartburn1/50 (2%)
    Ascites1/50 (2%)
    Leak, Gi - Rectum1/50 (2%)
    Ileus1/50 (2%)
    Dysphagia2/50 (4%)
    Taste Alteration6/50 (12%)
    Dry Mouth1/50 (2%)
    Mucositis (Functional/Sympt) - Oral Cavity4/50 (8%)
    Obstruction, Gi - Small Bowel Nos1/50 (2%)
    Mucositis (Clinical Exam) - Oral Cavity6/50 (12%)
    Mucositis (Clinical Exam) - Esophagus1/50 (2%)
    Vomiting19/50 (38%)
    Anorexia25/50 (50%)
    Dehydration4/50 (8%)
    Constipation24/50 (48%)
    Nausea22/50 (44%)
    Diarrhea22/50 (44%)
    General disorders
    Sweating3/50 (6%)
    Patient Odor1/50 (2%)
    Fever5/50 (10%)
    Weight Loss4/50 (8%)
    Rigors/Chills4/50 (8%)
    Fatigue40/50 (80%)
    Insomnia7/50 (14%)
    Pain: Pelvis2/50 (4%)
    Pain: Breast1/50 (2%)
    Pain: Vagina1/50 (2%)
    Pain: Chest /Thorax Nos3/50 (6%)
    Pain: Chest Wall1/50 (2%)
    Pain: Eye1/50 (2%)
    Pain: Head/Headache7/50 (14%)
    Pain: Extremity-Limb11/50 (22%)
    Pain: Back8/50 (16%)
    Pain: Joint6/50 (12%)
    Pain: Bone3/50 (6%)
    Pain: Kidney1/50 (2%)
    Pain: Bladder2/50 (4%)
    Pain: Pain Nos2/50 (4%)
    Pain: Stomach2/50 (4%)
    Pain: Oral Cavity1/50 (2%)
    Pain: Abdominal Pain Nos14/50 (28%)
    Pain: Middle Ear1/50 (2%)
    Pain: Tumor1/50 (2%)
    Pain: Muscle8/50 (16%)
    Pain: Neuralgia2/50 (4%)
    Immune system disorders
    Allergic Reaction/Hypersensitivity2/50 (4%)
    Rhinitis4/50 (8%)
    Infections and infestations
    Inf W/Gr 3 Or 4 Anc: Blood1/50 (2%)
    Inf W/Gr 3 Or 4 Anc: Middle Ear1/50 (2%)
    Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos1/50 (2%)
    Inf W/Nml Or Gr 1 Or 2 Anc: Oral Cavity-Gums1/50 (2%)
    Inf W/Nml Or Gr 1 Or 2 Anc: Catheter-Related1/50 (2%)
    Febrile Neutropenia3/50 (6%)
    Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos1/50 (2%)
    Infection - Other1/50 (2%)
    Inf W/Nml Or Gr 1 Or 2 Anc: Conjunctiva1/50 (2%)
    Inf W/Nml Or Gr 1 Or 2 Anc: Bronchus1/50 (2%)
    Inf Unknown Anc: Urinary Tract Nos7/50 (14%)
    Inf Unknown Anc: Bladder (Urinary)1/50 (2%)
    Inf Unknown Anc: Lip/Perioral1/50 (2%)
    Inf W/Gr 3 Or 4 Anc: Upper Airway Nos1/50 (2%)
    Inf W/Nml Or Gr 1 Or 2 Anc: Bladder2/50 (4%)
    Inf W/Gr 3 Or 4 Anc: Urinary Tract Nos4/50 (8%)
    Metabolism and nutrition disorders
    Ast4/50 (8%)
    Gfr1/50 (2%)
    Proteinuria3/50 (6%)
    Hemoglobinuria1/50 (2%)
    Creatinine10/50 (20%)
    Hypoalbuminemia10/50 (20%)
    Alt1/50 (2%)
    Alkaline Phosphatase4/50 (8%)
    Bilirubin3/50 (6%)
    Hyponatremia13/50 (26%)
    Hypernatremia1/50 (2%)
    Hypocalcemia9/50 (18%)
    Hyperkalemia2/50 (4%)
    Hyperglycemia14/50 (28%)
    Hypokalemia12/50 (24%)
    Hypoglycemia2/50 (4%)
    Hypomagnesemia15/50 (30%)
    Musculoskeletal and connective tissue disorders
    Joint-Function1/50 (2%)
    Arthritis1/50 (2%)
    Muscle Weakness - Whole Body/Generalized3/50 (6%)
    Muscle Weakness - Left-Sided1/50 (2%)
    Muscle Weakness - Extremity-Lower2/50 (4%)
    Nervous system disorders
    Mood Alteration - Depression5/50 (10%)
    Mood Alteration - Anxiety1/50 (2%)
    Ataxia1/50 (2%)
    Confusion1/50 (2%)
    Memory Impairment2/50 (4%)
    Dizziness6/50 (12%)
    Neuropathy-Sensory32/50 (64%)
    Neuropathy-Motor5/50 (10%)
    Renal and urinary disorders
    Leak, Gu - Vagina1/50 (2%)
    Cystitis1/50 (2%)
    Urinary Retention1/50 (2%)
    Obstruction, Gu - Ureter1/50 (2%)
    Incontinence, Urinary4/50 (8%)
    Bladder Spasm1/50 (2%)
    Urinary Frequency2/50 (4%)
    Reproductive system and breast disorders
    Vaginal Discharge1/50 (2%)
    Respiratory, thoracic and mediastinal disorders
    Voice Changes1/50 (2%)
    Hypoxia2/50 (4%)
    Hiccoughs2/50 (4%)
    Cough11/50 (22%)
    Pneumonitis2/50 (4%)
    Pleural Effusion2/50 (4%)
    Dyspnea17/50 (34%)
    Skin and subcutaneous tissue disorders
    Nail Changes6/50 (12%)
    Hair Loss/Alopecia (Scalp Or Body)30/50 (60%)
    Bruising1/50 (2%)
    Rash8/50 (16%)
    Dry Skin3/50 (6%)
    Pruritus3/50 (6%)
    Flushing1/50 (2%)
    Hyperpigmentation1/50 (2%)
    Ulceration1/50 (2%)
    Vascular disorders
    Inr1/50 (2%)
    Hemorrhage, Gu - Urinary Nos2/50 (4%)
    Hemorrhage, Gu - Vagina4/50 (8%)
    Hemorrhage, Gi - Rectum2/50 (4%)
    Hemorrhage, Gi - Upper Gi Nos1/50 (2%)
    Hemorrhage/Pulmonary - Nose2/50 (4%)
    Hemorrhage, Gu - Bladder1/50 (2%)
    Thrombosis/Thrombus/Embolism5/50 (10%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT 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/TitleAngela M. Kuras, Associate Director of Data Management
    OrganizationNRG Oncology Statistics and Data Management Center - Buffalo
    Phone716-845-7733
    Emailkurasa@nrgoncology.org
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00095979
    Other Study ID Numbers:
    • NCI-2012-02628
    • NCI-2012-02628
    • CDR0000391849
    • GOG-0129P
    • GOG-0129P
    • U10CA027469
    First Posted:
    Nov 9, 2004
    Last Update Posted:
    Jul 24, 2019
    Last Verified:
    Jul 1, 2019