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Paclitaxel + Bevacizumab (Avastin) for the Treatment of Metastatic or Unresectable Angiosarcoma

Sponsor
Stanford University (Other)
Overall Status
Terminated
CT.gov ID
NCT01055028
Collaborator
Genentech, Inc. (Industry)
18
Enrollment
3
Locations
2
Arms
76.7
Duration (Months)
6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an open-label, single-arm, multi-center, Phase 2 study with Paclitaxel in combination with Bevacizumab in patients with Unresectable or Metastatic Angiosarcoma. The study aims to determine the safety and effectiveness of combining two drugs Paclitaxel and Bevacizumab in the treatment of Angiosarcoma that cannot be removed by surgery, or has spread to other parts of your body. The primary objective is to evaluate 4month non progression rate. The secondary objective is to evaluate overall response rate after 3rd and 6th cycle, median duration of response, 6th and 12th month survival, toxicity of Paclitaxel and Bevacizumab combination, toxicity of maintenance Bevacizumab and to collect paraffin-embedded tumor blocks for angiogenesis markers and tissue microarray.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Regimen A versus B was chosen at the discretion of the treating physician. Both groups were analyzed together as far as outcome.

Patients were to receive paclitaxel 200 mg/m2 intravenously over 3 hours every 21 days (Regimen A) or pactlitaxel 90 mg/m2 weekly x 3 of a 28 day cycle (Regimen B) followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3-6: 30 min) every 21 days x 6 cycles. Maintenance bevacizumab (MB) started after the completion of combination of paclitaxel and bevacizumab and it was given at a dose of 15 mg/kg intravenously once every 21 days for a maximum of 8 cycles. Patients were allowed to receive growth factors. Dose reductions were done based on hematologic and non-hematologic toxicities.

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Paclitaxel in Combination With Bevacizumab (Avastin) for the Treatment of Metastatic or Unresectable Angiosarcoma
Study Start Date :
Feb 1, 2010
Actual Primary Completion Date :
Mar 1, 2016
Actual Study Completion Date :
Jun 24, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Regimen A / Treatment 1

Participants were to receive paclitaxel 200 mg/m² intravenously over 3 hours every 21 days followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles. Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination.

Drug: Bevacizumab
15 mg/kg, IV every 21 days x 6 cycles.
Other Names:
  • Avastin

    • Drug: Paclitaxel
    Regimen A / Treatment 1: 200 mg/m² IV over 3 hours every 21 days. Regimen B / Treatment 2: 90 mg/m² weekly x 3 of a 28-day cycle
    Other Names:
  • Abraxane

    		•
    Experimental: Regimen B / Treatment 2

    Patients were to receive paclitaxel 90 mg/m² weekly x 3 of a 28-day cycle followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles. Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination.

    Drug: Bevacizumab
    15 mg/kg, IV every 21 days x 6 cycles.
    Other Names:
  • Avastin

    • Drug: Paclitaxel
    Regimen A / Treatment 1: 200 mg/m² IV over 3 hours every 21 days. Regimen B / Treatment 2: 90 mg/m² weekly x 3 of a 28-day cycle
    Other Names:
  • Abraxane

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free Survival (PFS) [4 months]

      The primary objective of this study was to evaluate progression-free survival (PFS or non-progression rate) through 4 months from start of treatment. Progression is defined as ≥ 20% increase in the sum of the longest diameter of target lesions, as compared to the baseline measurements, and/or the appearance of one or more new lesion(s).

    Secondary Outcome Measures

    1. Overall Response Rate After 3 Cycles [12 weeks]

      Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria, per protocol. Overall response rate (ORR) is the sum of the Complete Response (CR) + Partial Response (PR) rates. The ORR for participants after 3 cycles of treatment (12 weeks) is expressed as the number and proportion of subjects. RECIST Criteria CR = Disappearance of all target lesions PR = ≥ 30% decrease in the sum of the longest diameter of target lesions Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s), Stable disease (SD) = Small changes that do not meet any of the above criteria

    2. Overall Response Rate After 6th Cycle [6 Cycles]

      Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria, per protocol. Overall response rate (ORR) is the sum of the Complete Response (CR) + Partial Response (PR) rates. The ORR for participants after 6 cycles of treatment (24 weeks) is expressed as the number and proportion of subjects. RECIST Criteria CR = Disappearance of all target lesions PR = ≥ 30% decrease in the sum of the longest diameter of target lesions Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s), Stable disease (SD) = Small changes that do not meet any of the above criteria

    3. Overall Survival (OS) at 6 Months [6 months]

      Assessed as the number of subjects known to remain alive 6 months after study entry

    4. Overall Survival (OS) at 12 Months [12 months]

      Assessed as the number of subjects known to remain alive 12 months after study entry

    Eligibility Criteria

    Criteria

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

    INCLUSION CRITERIA

    • Baseline measurements and evaluations must be obtained within 4 weeks of registration to the study. Abnormal PET scans will not constitute evaluable disease, unless verified by computed tomography (CT) scan or other appropriate imaging

    • At least 1 objective measurable disease parameter by Response Evaluation Criteria In Solid Tumors (RECIST) criteria

    • Unresectable locally advanced or metastatic angiosarcoma

    • ≤ 2 prior chemotherapeutic regimens for angiosarcoma

    • No prior paclitaxel, docetaxel, or bevacizumab for angiosarcoma (previous paclitaxel or docetaxel allowed if not given for angiosarcoma and more than 12 months has elapsed since last dose)

    • No evidence of other active malignancies other than carcinomas in-situ of the cervix or basal cell carcinoma of the skin within 6 months prior to registration

    • If history of deep venous thrombosis or pulmonary embolism, receiving a stable dose of anticoagulation therapy for at least 2 weeks prior to registration

    • Within 7 days prior to registration, use of any anti-platelet drugs, such as ticlopidine, clopidogrel, and cilostazol. The use of aspirin or other nonsteroidal anti-inflammatory drugs (NSAID) is allowed

    • ECOG performance status 0 to 2

    • Patients must have adequate organ function as evidenced by the following laboratory studies (within 2 weeks prior to registration):

    • Serum creatinine ≤ 2.0 mg/dL

    • Total bilirubin ≤ 2.0 x upper limit of normal (ULN). If documented hepatic involvement, can be ≤ 3 x ULN

    • Serum glutamic oxaloacetic transaminase (SGOT) or Aspartate aminotransferase (AST) < 2 x ULN. If documented hepatic involvement, can be ≤ 5 x ULN

    • Absolute neutrophil count ≥ 1500/mm3 and platelet count > 100,000/mm3

    • Platelets ≤ 1.5 x ULN

    • International normalized ratio (INR) ≤ 1.5 x ULN

    • Partial thromboplastin time (PTT) ≤ 1.5 x ULN

    • Left ventricular ejection fraction ≥ 50%

    • ≥ 18 years

    • Women of childbearing potential must have a negative human chorionic gonadotropin (hCG) pregnancy test within 2 weeks prior to registration

    EXCLUSION CRITERIA

    • Life expectancy < 12 weeks

    • Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an another experimental drug study

    • Inadequately-controlled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg)

    • History of hypertensive crisis or hypertensive encephalopathy

    • New York Heart Association (NYHA) Grade II or greater congestive heart failure

    • History of myocardial infarction or unstable angina within 6 months prior to Day 1

    • History of stroke or transient ischemic attack within 6 months prior to Day 1

    • Known central nervous system (CNS) disease, except for treated brain metastasis. Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, LINAC, or equivalent) or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded.

    • Significant vascular disease (eg, aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1

    • History of hemoptysis (≥ 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1

    • Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)

    • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 or anticipation of need for major surgical procedure during the course of the study

    • Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1

    • History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1

    • Serious, non-healing wound, active ulcer, or untreated bone fracture

    • Proteinuria as demonstrated by a urine protein: creatinine ratio (UPC) ratio ≥ 1.0 at screening

    • Known hypersensitivity to any component of bevacizumab

    • Active infection requiring parental antibiotics

    • Known human immunodeficiency virus (HIV) infection

    • Pregnant or breast feeding

    • Inability to comply with study and/or follow-up procedures

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Santa Monica Sarcoma Center Santa Monica California United States 90403
    2 Stanford University Medical Center Stanford California United States 94305
    3 MD Anderson Sarcoma Center Houston Texas United States 77030

    Sponsors and Collaborators

    • Stanford University
    • Genentech, Inc.

    Investigators

    • Principal Investigator: Kristen N Ganjoo, MD, Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kristen Ganjoo, Assistant Professor of Medicine, Stanford University
    ClinicalTrials.gov Identifier:
    NCT01055028
    Other Study ID Numbers:
    • IRB-17755
    • SU-01202010-4743
    • SARCOMA0006
    First Posted:
    Jan 25, 2010
    Last Update Posted:
    Mar 26, 2018
    Last Verified:
    May 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Sarcoma
    Hemangiosarcoma
    Paclitaxel
    Bevacizumab

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Regimen A Treatment 1 Regimen B Treatment 2
    Arm/Group Description Participants were to receive paclitaxel 200 mg/m² intravenously over 3 hours every 21 days followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles. Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination. Patients were to receive paclitaxel 90 mg/m² weekly x 3 of a 28-day cycle followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles. Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination.
    Period Title: Screening
    STARTED 9 9
    COMPLETED 8 8
    NOT COMPLETED 1 1
    Period Title: Screening
    STARTED 8 8
    COMPLETED 6 5
    NOT COMPLETED 2 3
    Period Title: Screening
    STARTED 6 5
    COMPLETED 6 2
    NOT COMPLETED 0 3
    Period Title: Screening
    STARTED 6 2
    COMPLETED 6 2
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title Regimen A Treatment 1 Regimen B Treatment 2 Total
    Arm/Group Description Participants were to receive paclitaxel 200 mg/m² intravenously over 3 hours every 21 days followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles. Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination. Patients were to receive paclitaxel 90 mg/m² weekly x 3 of a 28-day cycle followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles. Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination. Total of all reporting groups
    Overall Participants 9 9 18
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    3
    33.3%
    3
    33.3%
    6
    33.3%
    >=65 years
    6
    66.7%
    6
    66.7%
    12
    66.7%
    Sex: Female, Male (Count of Participants)
    Female
    5
    55.6%
    4
    44.4%
    9
    50%
    Male
    4
    44.4%
    5
    55.6%
    9
    50%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    1
    11.1%
    0
    0%
    1
    5.6%
    Not Hispanic or Latino
    8
    88.9%
    9
    100%
    17
    94.4%
    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%
    1
    11.1%
    1
    5.6%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    2
    22.2%
    0
    0%
    2
    11.1%
    White
    7
    77.8%
    8
    88.9%
    15
    83.3%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%

    Outcome Measures

    1. Primary Outcome
    Title Progression-free Survival (PFS)
    Description The primary objective of this study was to evaluate progression-free survival (PFS or non-progression rate) through 4 months from start of treatment. Progression is defined as ≥ 20% increase in the sum of the longest diameter of target lesions, as compared to the baseline measurements, and/or the appearance of one or more new lesion(s).
    Time Frame 4 months

    Outcome Measure Data

    Analysis Population Description
    Includes all subjects that started treatment
    Arm/Group Title Regimen A Treatment 1 Regimen B Treatment 2
    Arm/Group Description Participants were to receive paclitaxel 200 mg/m² intravenously over 3 hours every 21 days followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles. Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination. Patients were to receive paclitaxel 90 mg/m² weekly x 3 of a 28-day cycle followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles. Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination.
    Measure Participants 8 8
    Number [Participants without disease progression]
    4
    44.4%
    5
    55.6%
    2. Secondary Outcome
    Title Overall Response Rate After 3 Cycles
    Description Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria, per protocol. Overall response rate (ORR) is the sum of the Complete Response (CR) + Partial Response (PR) rates. The ORR for participants after 3 cycles of treatment (12 weeks) is expressed as the number and proportion of subjects. RECIST Criteria CR = Disappearance of all target lesions PR = ≥ 30% decrease in the sum of the longest diameter of target lesions Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s), Stable disease (SD) = Small changes that do not meet any of the above criteria
    Time Frame 12 weeks

    Outcome Measure Data

    Analysis Population Description
    Includes participants that complete 3 cycles of treatment
    Arm/Group Title Regimen A Treatment 1 Regimen B Treatment 2
    Arm/Group Description Participants were to receive paclitaxel 200 mg/m² intravenously over 3 hours every 21 days followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles. Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination. Patients were to receive paclitaxel 90 mg/m² weekly x 3 of a 28-day cycle followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles. Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination.
    Measure Participants 6 5
    Complete Response (CR)
    1
    11.1%
    0
    0%
    Partial Response (PR)
    2
    22.2%
    2
    22.2%
    Stable Disease (SD)
    1
    11.1%
    2
    22.2%
    Progressive Disease (PD)
    2
    22.2%
    1
    11.1%
    3. Secondary Outcome
    Title Overall Response Rate After 6th Cycle
    Description Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria, per protocol. Overall response rate (ORR) is the sum of the Complete Response (CR) + Partial Response (PR) rates. The ORR for participants after 6 cycles of treatment (24 weeks) is expressed as the number and proportion of subjects. RECIST Criteria CR = Disappearance of all target lesions PR = ≥ 30% decrease in the sum of the longest diameter of target lesions Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s), Stable disease (SD) = Small changes that do not meet any of the above criteria
    Time Frame 6 Cycles

    Outcome Measure Data

    Analysis Population Description
    Includes participants that complete 6 cycles of treatment
    Arm/Group Title Regimen A Treatment 1 Regimen B Treatment 2
    Arm/Group Description Patients were to receive paclitaxel (A) 200 mg/m² intravenously over 3 hours every 21 days followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3-6: 30 min) every 21 days x 6 cycles. Maintenance bevacizumab (MB) started after the completion of a combination of paclitaxel and bevacizumab and it was given at a dose of 15 mg/kg intravenously once every 21 days for a maximum of 8 cycles. Patients were to receive paclitaxel (B) 90 mg/m² weekly x 3 of a 28 day cycle followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3-6: 30 min) every 21 days x 6 cycles. Maintenance bevacizumab (MB) started after the completion of a combination of paclitaxel and bevacizumab and it was given at a dose of 15 mg/kg intravenously once every 21 days for a maximum of 8 cycles.
    Measure Participants 6 2
    Complete Response (CR)
    1
    11.1%
    0
    0%
    Partial Response (PR)
    2
    22.2%
    0
    0%
    Stable Disease (SD)
    1
    11.1%
    1
    11.1%
    Progressive Disease (PD)
    2
    22.2%
    1
    11.1%
    4. Secondary Outcome
    Title Overall Survival (OS) at 6 Months
    Description Assessed as the number of subjects known to remain alive 6 months after study entry
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Regimen A / Treatment 1 Regimen B / Treatment 2
    Arm/Group Description Participants were to receive paclitaxel 200 mg/m² intravenously over 3 hours every 21 days followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles. Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination. Bevacizumab: 15 mg/kg, IV every 21 days x 6 cycles. Paclitaxel: Regimen A / Treatment 1: 200 mg/m² IV over 3 hours every 21 days. Regimen B / Treatment 2: 90 mg/m² weekly x 3 of a 28-day cycle Patients were to receive paclitaxel 90 mg/m² weekly x 3 of a 28-day cycle followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles. Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination. Bevacizumab: 15 mg/kg, IV every 21 days x 6 cycles. Paclitaxel: Regimen A / Treatment 1: 200 mg/m² IV over 3 hours every 21 days. Regimen B / Treatment 2: 90 mg/m² weekly x 3 of a 28-day cycle
    Measure Participants 8 8
    Count of Participants [Participants]
    7
    77.8%
    8
    88.9%
    5. Secondary Outcome
    Title Overall Survival (OS) at 12 Months
    Description Assessed as the number of subjects known to remain alive 12 months after study entry
    Time Frame 12 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Regimen A / Treatment 1 Regimen B / Treatment 2
    Arm/Group Description Participants were to receive paclitaxel 200 mg/m² intravenously over 3 hours every 21 days followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles. Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination. Bevacizumab: 15 mg/kg, IV every 21 days x 6 cycles. Paclitaxel: Regimen A / Treatment 1: 200 mg/m² IV over 3 hours every 21 days. Regimen B / Treatment 2: 90 mg/m² weekly x 3 of a 28-day cycle Patients were to receive paclitaxel 90 mg/m² weekly x 3 of a 28-day cycle followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles. Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination. Bevacizumab: 15 mg/kg, IV every 21 days x 6 cycles. Paclitaxel: Regimen A / Treatment 1: 200 mg/m² IV over 3 hours every 21 days. Regimen B / Treatment 2: 90 mg/m² weekly x 3 of a 28-day cycle
    Measure Participants 8 8
    Count of Participants [Participants]
    6
    66.7%
    6
    66.7%

    Adverse Events

    Time Frame 7 years
    Adverse Event Reporting Description
    Arm/Group Title Regimen A Treatment 1 Regimen B Treatment 2
    Arm/Group Description Patients were to receive paclitaxel (A) 200 mg/m² intravenously over 3 hours every 21 days followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3-6: 30 min) every 21 days x 6 cycles. Maintenance bevacizumab (MB) started after the completion of a combination of paclitaxel and bevacizumab and it was given at a dose of 15 mg/kg intravenously once every 21 days for a maximum of 8 cycles. Patients were to receive paclitaxel (B) 90 mg/m² weekly x 3 of a 28 day cycle followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3-6: 30 min) every 21 days x 6 cycles. Maintenance bevacizumab (MB) started after the completion of a combination of paclitaxel and bevacizumab and it was given at a dose of 15 mg/kg intravenously once every 21 days for a maximum of 8 cycles.
    All Cause Mortality
    Regimen A Treatment 1 Regimen B Treatment 2
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/8 (0%) 0/8 (0%)
    Serious Adverse Events
    Regimen A Treatment 1 Regimen B Treatment 2
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 8/8 (100%) 4/8 (50%)
    Blood and lymphatic system disorders
    Neutropenia 1/8 (12.5%) 1 0/8 (0%) 0
    Cardiac disorders
    Congestive heart failure 1/8 (12.5%) 1 0/8 (0%) 0
    Atrial flutter 0/8 (0%) 0 1/8 (12.5%) 1
    Circumflex artery occlusion 0/8 (0%) 0 1/8 (12.5%) 1
    Pleuritic right chest pain 1/8 (12.5%) 1 0/8 (0%) 0
    Gastrointestinal disorders
    Colon perforation 0/8 (0%) 0 1/8 (12.5%) 1
    General disorders
    Fever 1/8 (12.5%) 1 1/8 (12.5%) 1
    Progression of aggressive tumor 1/8 (12.5%) 1 0/8 (0%) 0
    Musculoskeletal and connective tissue disorders
    Increased right hip pain 1/8 (12.5%) 1 0/8 (0%) 0
    Renal and urinary disorders
    Urinary tract infection 1/8 (12.5%) 1 0/8 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia 1/8 (12.5%) 1 0/8 (0%) 0
    Other (Not Including Serious) Adverse Events
    Regimen A Treatment 1 Regimen B Treatment 2
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 8/8 (100%) 8/8 (100%)
    Blood and lymphatic system disorders
    Anemia 2/8 (25%) 4 2/8 (25%) 2
    Hemoglobinemia 3/8 (37.5%) 10 2/8 (25%) 3
    Nose hemorrhage 1/8 (12.5%) 1 0/8 (0%) 0
    Worsened anemia 1/8 (12.5%) 1 0/8 (0%) 0
    Occasional hypertension 0/8 (0%) 0 1/8 (12.5%) 1
    Occasional Hypomagnesemia 0/8 (0%) 0 1/8 (12.5%) 1
    Occasional hyponatremia 0/8 (0%) 0 1/8 (12.5%) 1
    Cardiac disorders
    Atrial flutter 0/8 (0%) 0 1/8 (12.5%) 1
    Sinus Tachycardia 1/8 (12.5%) 1 0/8 (0%) 0
    Ear and labyrinth disorders
    Earache 0/8 (0%) 0 1/8 (12.5%) 1
    Eye disorders
    Change in vision 0/8 (0%) 0 1/8 (12.5%) 1
    Eye irritation 0/8 (0%) 0 1/8 (12.5%) 1
    Gastrointestinal disorders
    Nausea 2/8 (25%) 2 1/8 (12.5%) 1
    Intermittent nausea 1/8 (12.5%) 1 0/8 (0%) 0
    Vomiting 2/8 (25%) 2 0/8 (0%) 0
    Intermittent vomiting 1/8 (12.5%) 1 0/8 (0%) 0
    Diarrhea 0/8 (0%) 0 1/8 (12.5%) 1
    Intermittent diarrhea 1/8 (12.5%) 1 0/8 (0%) 0
    Intermittent stomach pain/ache 1/8 (12.5%) 1 0/8 (0%) 0
    Occasional indigestion 0/8 (0%) 0 1/8 (12.5%) 1
    Anorexia 2/8 (25%) 2 3/8 (37.5%) 3
    Occasional abdominal pain 0/8 (0%) 0 1/8 (12.5%) 1
    Abdominal pain 0/8 (0%) 0 1/8 (12.5%) 1
    Diverticulitis 0/8 (0%) 0 1/8 (12.5%) 1
    Gas pain 0/8 (0%) 0 1/8 (12.5%) 1
    Dysphagia intermittent 1/8 (12.5%) 1 0/8 (0%) 0
    Dysphagia 1/8 (12.5%) 1 1/8 (12.5%) 1
    Worsening pain left flank 1/8 (12.5%) 1 0/8 (0%) 0
    Mouth sores 1/8 (12.5%) 1 0/8 (0%) 0
    Mouth irritation 1/8 (12.5%) 1 2/8 (25%) 2
    Esophagitis 0/8 (0%) 0 1/8 (12.5%) 1
    Ateration in taste 0/8 (0%) 0 2/8 (25%) 2
    Metallic taste 1/8 (12.5%) 1 0/8 (0%) 0
    Sore throat 1/8 (12.5%) 1 0/8 (0%) 0
    Intermittent xerostomia 1/8 (12.5%) 1 0/8 (0%) 0
    Constipation 1/8 (12.5%) 1 1/8 (12.5%) 1
    Hemorrhoidal hemorrhage 1/8 (12.5%) 1 0/8 (0%) 0
    Rectal bleeding 0/8 (0%) 0 1/8 (12.5%) 1
    Increased oral cavity bleeding 0/8 (0%) 0 1/8 (12.5%) 1
    Weight loss 0/8 (0%) 0 1/8 (12.5%) 1
    Mucositis 0/8 (0%) 0 1/8 (12.5%) 1
    Hemoptysis 1/8 (12.5%) 1 0/8 (0%) 0
    Occasional diarrhea 0/8 (0%) 0 1/8 (12.5%) 1
    Occasional nausea 0/8 (0%) 0 1/8 (12.5%) 1
    General disorders
    Fatigue 4/8 (50%) 6 4/8 (50%) 5
    Headache 1/8 (12.5%) 1 1/8 (12.5%) 1
    Fever 3/8 (37.5%) 3 0/8 (0%) 0
    Intermittent fever 0/8 (0%) 0 1/8 (12.5%) 1
    Gait disorder 2/8 (25%) 2 0/8 (0%) 0
    Hot flashes occasional 1/8 (12.5%) 1 0/8 (0%) 0
    Weakness 2/8 (25%) 3 0/8 (0%) 0
    Cold intolerance 1/8 (12.5%) 1 0/8 (0%) 0
    Voice changes 2/8 (25%) 2 0/8 (0%) 0
    Chills 1/8 (12.5%) 1 0/8 (0%) 0
    Headache-occasional 1/8 (12.5%) 1 1/8 (12.5%) 1
    Infections and infestations
    Bacteremia 1/8 (12.5%) 1 0/8 (0%) 0
    Afebrile neutropenia 0/8 (0%) 0 1/8 (12.5%) 1
    Intermittent fever 1/8 (12.5%) 1 0/8 (0%) 0
    Investigations
    Neutropenia 4/8 (50%) 4 7/8 (87.5%) 7
    Thrombocytopenia 3/8 (37.5%) 8 0/8 (0%) 0
    Elevated alkaline phosphatase 3/8 (37.5%) 8 1/8 (12.5%) 1
    Elevated Aspartate Aminotransferase 1/8 (12.5%) 1 2/8 (25%) 2
    Elevated Alanine Aminotransferease 1/8 (12.5%) 2 1/8 (12.5%) 4
    Hyperbilirubinemia 0/8 (0%) 0 1/8 (12.5%) 1
    Prolonged international normalized ratio 1/8 (12.5%) 1 0/8 (0%) 0
    Increased creatinine 1/8 (12.5%) 1 0/8 (0%) 0
    Increased B-natriuretic peptide 1/8 (12.5%) 1 0/8 (0%) 0
    Oral irritation 0/8 (0%) 0 1/8 (12.5%) 1
    Metabolism and nutrition disorders
    Hypokalemia 2/8 (25%) 2 0/8 (0%) 0
    Hyponatremia 3/8 (37.5%) 4 1/8 (12.5%) 1
    Hypophosphatemia 1/8 (12.5%) 1 0/8 (0%) 0
    Hypoalbuminemia 2/8 (25%) 2 0/8 (0%) 0
    Hypocalcemia 1/8 (12.5%) 1 0/8 (0%) 0
    Elevated uric acid 1/8 (12.5%) 2 0/8 (0%) 0
    Hypomagnesemia 0/8 (0%) 0 1/8 (12.5%) 1
    Hypermagnesemia 1/8 (12.5%) 1 0/8 (0%) 0
    Elevated potassium 1/8 (12.5%) 1 0/8 (0%) 0
    Hyperglycemia 1/8 (12.5%) 1 0/8 (0%) 0
    Musculoskeletal and connective tissue disorders
    Body aches 1/8 (12.5%) 1 0/8 (0%) 0
    Restless legs 1/8 (12.5%) 1 0/8 (0%) 0
    Pain left leg 1/8 (12.5%) 1 0/8 (0%) 0
    occasional pain on left scalp 1/8 (12.5%) 1 0/8 (0%) 0
    Bone pain 2/8 (25%) 2 0/8 (0%) 0
    Pain left face 1/8 (12.5%) 1 0/8 (0%) 0
    Worsened R hip pain 1/8 (12.5%) 1 0/8 (0%) 0
    Myalgia 1/8 (12.5%) 1 1/8 (12.5%) 1
    Myalgia intermittent 0/8 (0%) 0 1/8 (12.5%) 1
    Pain-Myalgia 1/8 (12.5%) 1 0/8 (0%) 0
    Muscle weakness 0/8 (0%) 0 1/8 (12.5%) 1
    Difficulty walking 0/8 (0%) 0 1/8 (12.5%) 1
    Joint pain 0/8 (0%) 0 1/8 (12.5%) 1
    Edema left arm 0/8 (0%) 0 1/8 (12.5%) 1
    Abdominal pain 0/8 (0%) 0 1/8 (12.5%) 1
    Intermittent leg cramps 1/8 (12.5%) 1 0/8 (0%) 0
    Pain left chest wall- occasional 1/8 (12.5%) 1 0/8 (0%) 0
    Pain right hip 0/8 (0%) 0 1/8 (12.5%) 1
    Nervous system disorders
    Intermittent dizziness 1/8 (12.5%) 1 0/8 (0%) 0
    Lightheadedness 1/8 (12.5%) 1 0/8 (0%) 0
    Peripheral neuropathy 2/8 (25%) 2 0/8 (0%) 0
    Worsening peripheral neuropathy 1/8 (12.5%) 1 0/8 (0%) 0
    Neuropathy feet 1/8 (12.5%) 1 0/8 (0%) 0
    Neuropathy toes 3/8 (37.5%) 3 0/8 (0%) 0
    Numbness/tingling feet 1/8 (12.5%) 1 0/8 (0%) 0
    Numbness/tingling hands 1/8 (12.5%) 1 0/8 (0%) 0
    Neuropathy fingertips 2/8 (25%) 2 2/8 (25%) 2
    Sensory neuropathy fingers/toes 1/8 (12.5%) 1 0/8 (0%) 0
    Sensory neuropathy both lower extremities 0/8 (0%) 0 1/8 (12.5%) 1
    Tingling fingertips 0/8 (0%) 0 1/8 (12.5%) 1
    Memory impairment 1/8 (12.5%) 1 0/8 (0%) 0
    Neuropathic pain feet 1/8 (12.5%) 1 0/8 (0%) 0
    Night sweats 1/8 (12.5%) 1 0/8 (0%) 0
    Numbness tingling toes/soles 1/8 (12.5%) 1 0/8 (0%) 0
    Occasional headache 0/8 (0%) 0 1/8 (12.5%) 1
    Psychiatric disorders
    Insomnia 2/8 (25%) 2 1/8 (12.5%) 1
    Delerium 1/8 (12.5%) 1 0/8 (0%) 0
    Agitation 1/8 (12.5%) 1 0/8 (0%) 0
    Depression 1/8 (12.5%) 1 0/8 (0%) 0
    Reproductive system and breast disorders
    Vaginal dryness 1/8 (12.5%) 1 0/8 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Epistaxis 1/8 (12.5%) 1 1/8 (12.5%) 1
    Bronchitis 1/8 (12.5%) 1 0/8 (0%) 0
    Epistaxis intermittent 0/8 (0%) 0 3/8 (37.5%) 3
    Dyspnea 2/8 (25%) 2 1/8 (12.5%) 1
    Dyspnea-Occasional 0/8 (0%) 0 1/8 (12.5%) 1
    Increasing shortness of breath 1/8 (12.5%) 1 0/8 (0%) 0
    Bilateral crackles lungs 1/8 (12.5%) 1 1/8 (12.5%) 1
    Pneumonia 1/8 (12.5%) 1 0/8 (0%) 0
    Nasal congestion 0/8 (0%) 0 2/8 (25%) 2
    Cough 2/8 (25%) 2 0/8 (0%) 0
    Sinus congestion 0/8 (0%) 0 1/8 (12.5%) 1
    Sinus infection 0/8 (0%) 0 1/8 (12.5%) 1
    Rhinorrhea 0/8 (0%) 0 1/8 (12.5%) 1
    Rhinitis 0/8 (0%) 0 1/8 (12.5%) 1
    Skin and subcutaneous tissue disorders
    Alopecia 5/8 (62.5%) 6 5/8 (62.5%) 5
    Easy bruising 1/8 (12.5%) 1 0/8 (0%) 0
    Pruritus nontargert lesion 1/8 (12.5%) 1 0/8 (0%) 0
    Rash on extremites 0/8 (0%) 0 1/8 (12.5%) 1
    Rash chest 0/8 (0%) 0 1/8 (12.5%) 1
    Rash back of neck 0/8 (0%) 0 1/8 (12.5%) 1
    Nail changes 0/8 (0%) 0 3/8 (37.5%) 4
    Nail infection 0/8 (0%) 0 1/8 (12.5%) 2
    Skin changes 0/8 (0%) 0 1/8 (12.5%) 1
    Folliculitis 0/8 (0%) 0 1/8 (12.5%) 1
    Erythema face 0/8 (0%) 0 1/8 (12.5%) 1
    Skin peeling face 0/8 (0%) 0 1/8 (12.5%) 1
    Scalp tightness 0/8 (0%) 0 1/8 (12.5%) 1
    Edema Left hand 0/8 (0%) 0 1/8 (12.5%) 1
    Edema left knee 1/8 (12.5%) 1 0/8 (0%) 0
    Hyperpigmented macule 1/8 (12.5%) 1 0/8 (0%) 0
    Rash arms 1/8 (12.5%) 1 0/8 (0%) 0
    Rash legs 1/8 (12.5%) 1 0/8 (0%) 0
    Vascular disorders
    Worsened hypertension 1/8 (12.5%) 1 0/8 (0%) 0

    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 Kristen Ganjoo, MD
    Organization Stanford University Medical Center
    Phone 650-725-6413
    Email kganjoo@stanford.edu
    Responsible Party:
    Kristen Ganjoo, Assistant Professor of Medicine, Stanford University
    ClinicalTrials.gov Identifier:
    NCT01055028
    Other Study ID Numbers:
    • IRB-17755
    • SU-01202010-4743
    • SARCOMA0006
    First Posted:
    Jan 25, 2010
    Last Update Posted:
    Mar 26, 2018
    Last Verified:
    May 1, 2017