- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01055028
Paclitaxel + Bevacizumab (Avastin) for the Treatment of Metastatic or Unresectable Angiosarcoma
Paclitaxel in Combination With Bevacizumab (Avastin) for the Treatment of Metastatic or Unresectable Angiosarcoma
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Santa Monica, California, United States, 90403
- Santa Monica Sarcoma Center
-
Stanford, California, United States, 94305
- Stanford University Medical Center
-
-
Texas
-
Houston, Texas, United States, 77030
- MD Anderson Sarcoma Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / 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. |
15 mg/kg, IV every 21 days x 6 cycles.
Other Names:
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:
|
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. |
15 mg/kg, IV every 21 days x 6 cycles.
Other Names:
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free Survival (PFS)
Time Frame: 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). |
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response Rate After 3 Cycles
Time Frame: 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
|
12 weeks
|
Overall Response Rate After 6th Cycle
Time Frame: 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
|
6 Cycles
|
Overall Survival (OS) at 6 Months
Time Frame: 6 months
|
Assessed as the number of subjects known to remain alive 6 months after study entry
|
6 months
|
Overall Survival (OS) at 12 Months
Time Frame: 12 months
|
Assessed as the number of subjects known to remain alive 12 months after study entry
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Vascular Tissue
- Sarcoma
- Hemangiosarcoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Paclitaxel
- Bevacizumab
Other Study ID Numbers
- IRB-17755
- SU-01202010-4743 (OTHER: Stanford University)
- SARCOMA0006 (OTHER: OnCore)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Soft Tissue Sarcoma
-
OHSU Knight Cancer InstituteNational Cancer Institute (NCI)WithdrawnStage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue Sarcoma | Stage II Adult Soft Tissue Sarcoma | Stage IIA Adult Soft Tissue Sarcoma | Stage IIB Adult Soft Tissue Sarcoma | Stage IIC Adult Soft Tissue Sarcoma
-
CytRxUnknownUnresectable Soft Tissue Sarcoma | Metastatic Soft Tissue Sarcoma | Locally Advanced Soft Tissue SarcomaUnited States, Australia, Russian Federation, Hungary, India, Romania, Ukraine
-
University of WashingtonAadi Bioscience, Inc.Active, not recruitingAdvanced Soft Tissue Sarcoma | Metastatic Soft Tissue Sarcoma | Locally Advanced Soft Tissue SarcomaUnited States
-
National Institutes of Health Clinical Center (CC)CompletedRecurrent Adult Soft Tissue Sarcoma | Stage III Adult Soft Tissue Sarcoma | Stage IVA Adult Soft Tissue Sarcoma | Stage IIB Adult Soft Tissue Sarcoma | Stage IIC Adult Soft Tissue Sarcoma | Stage IVB Adult Soft Tissue Sarcoma
-
National Cancer Institute (NCI)TerminatedRecurrent Adult Soft Tissue Sarcoma | Stage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue Sarcoma | Stage I Adult Soft Tissue Sarcoma | Stage II Adult Soft Tissue SarcomaUnited States
-
National Cancer Institute (NCI)RecruitingMetastatic Alveolar Soft Part Sarcoma | Unresectable Alveolar Soft Part Sarcoma | Advanced Soft Tissue Sarcoma | Advanced Alveolar Soft Part SarcomaUnited States
-
Centre Leon BerardNovartis; National Cancer Institute, FranceRecruitingAdvanced Soft-tissue Sarcoma | Metastatic Soft-tissue SarcomaFrance
-
UNICANCERRecruitingAdvanced Soft-tissue Sarcoma | Metastatic Soft-tissue SarcomaFrance
-
University of Colorado, DenverAgenus Inc.RecruitingAdvanced Soft Tissue Sarcoma | Metastatic Soft Tissue SarcomaUnited States
-
Wake Forest University Health SciencesMerck Sharp & Dohme LLCCompletedSoft Tissue Sarcoma, Adult | Soft Tissue Sarcoma, ChildUnited States
Clinical Trials on Bevacizumab
-
National Cancer Institute (NCI)Active, not recruitingRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Ovarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Serous Cystadenocarcinoma | Endometrial Clear Cell Adenocarcinoma | Endometrial Serous Adenocarcinoma | Recurrent... and other conditionsUnited States
-
National Cancer Institute (NCI)NRG OncologyCompletedGlioblastoma | Gliosarcoma | Recurrent Glioblastoma | Oligodendroglioma | Giant Cell Glioblastoma | Recurrent Brain NeoplasmUnited States, Canada
-
M.D. Anderson Cancer CenterRecruitingStage IB Hepatocellular Carcinoma AJCC v8 | Stage II Hepatocellular Carcinoma AJCC v8 | Resectable Hepatocellular Carcinoma | Stage I Hepatocellular Carcinoma AJCC v8 | Stage IA Hepatocellular Carcinoma AJCC v8United States
-
National Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Adenosquamous Carcinoma | Cervical Squamous Cell Carcinoma, Not Otherwise Specified | Stage IVA Cervical Cancer AJCC v6 and v7 | Recurrent Cervical Carcinoma | Stage IV Cervical Cancer AJCC v6 and v7 | Stage IVB Cervical Cancer AJCC v6 and v7United States
-
Northwestern UniversityNational Cancer Institute (NCI); Ipsen BiopharmaceuticalsCompletedRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Platinum-Resistant Fallopian Tube Carcinoma | Platinum-Resistant Primary Peritoneal Carcinoma | Platinum-Resistant Ovarian Carcinoma | Refractory Ovarian Carcinoma | Refractory Fallopian Tube... and other conditionsUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)RecruitingRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Clear Cell Adenocarcinoma | Fallopian Tube Adenocarcinoma | Fallopian Tube Serous Adenocarcinoma | Ovarian Serous Adenocarcinoma | Fallopian Tube... and other conditionsUnited States
-
National Cancer Institute (NCI)Active, not recruitingStage IV Cutaneous Melanoma AJCC v6 and v7 | Stage IIIC Cutaneous Melanoma AJCC v7 | Unresectable MelanomaUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); Merck Sharp & Dohme LLC; Celldex TherapeuticsRecruitingRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Recurrent Endometrial Serous Adenocarcinoma | Ovarian Clear Cell Adenocarcinoma | Recurrent Platinum-Resistant Ovarian Carcinoma | Platinum-Sensitive Ovarian Carcinoma | Recurrent Fallopian... and other conditionsUnited States
-
Mayo ClinicNational Cancer Institute (NCI)Active, not recruitingMalignant Solid Neoplasm | Ovarian Endometrioid Adenocarcinoma | Ovarian Undifferentiated Carcinoma | Cervical Adenocarcinoma | Cervical Adenosquamous Carcinoma | Malignant Peritoneal Neoplasm | Endometrial Clear Cell Adenocarcinoma | Endometrial Endometrioid Adenocarcinoma | Endometrial Mixed Cell... and other conditionsUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingMetastatic Lung Non-Small Cell Carcinoma | Stage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Stage III Lung Cancer AJCC v8 | Stage IV Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Stage IIIC Lung Cancer AJCC v8 | Locally Advanced Lung Non-Small... and other conditionsUnited States