Bevacizumab in Treating Patients With Angiosarcoma

NCT00288015 | Completed Phase 2 Results DMC

• 2 other identifiers: NU 04S1STU00006784
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 5

Brief Summary

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well bevacizumab works in treating patients with angiosarcoma.

Conditions

Sarcoma

Keywords

adult angiosarcoma; recurrent adult soft tissue sarcoma; stage I adult soft tissue sarcoma; stage II adult soft tissue sarcoma; stage III adult soft tissue sarcoma; stage IV adult soft tissue sarcoma

Outcome Measures

Primary Outcomes (1)

• Median Progression-free Survival of Patients Treated With the Study Drug as Defined by RECIST Criteria.

  During treatment, tumor assessment was done by MRI scan after the second cycle of study treatment, after the forth cycle of study treatment, and then every 3 cycles of treatment thereafter. After Study drug completion, tumor assessment by MRI was done every 3 to 4 months (for up to 2 years after the last bevacizumab dosage). Responses were categorized according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0. Progressive Disease (PD) was defined as having at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.

  After cycles 2 and 4, then every 3 cycles thereafter while on treatment (1 cycle = 21 days); every 3-4 months after treatment up to 2 years.

Secondary Outcomes (4)

• Objective Response Rate in Patients Treated With Bevacizumab.

  After cycles 2 and 4, then every 3 cycles thereafter while on treatment (1 cycle = 21 days); every 3-4 months after treatment up to 2 years.

• Duration of Response.

  After cycles 2 and 4, then every 3 cycles thereafter while on treatment (1 cycle = 21 days); every 3-4 months after treatment up to 2 years.

• Assess the Treatment Effect of Bevacizumab on Duration of Overall Survival

  After cycles 2 and 4, then every 3 cycles thereafter while on treatment (1 cycle = 21 days); every 3-4 months after treatment up to 2 years

• Evaluate the Toxicity of Bevacizumab.

  Day 1 of every cycle, on average every 21 days until end of treatment up to 2 years.

Study Arms (1)

Bevacizumab

EXPERIMENTAL

Bevacizumab treatment until disease progression or intolerance

Biological: Bevacizumab

Interventions

Bevacizumab BIOLOGICAL

Bevacizumab 15 mg/kg IV infusion given on day 1 every 21 days = (1 cycle).

Also known as: rhuMAb, VEGF, Avastin

Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed angiosarcoma * Any stage disease * Must be deemed not surgically resectable (complete resection) and/or no other therapeutic modality is known to be curative * No angiosarcoma of a vessel wall * Newly diagnosed or recurrent/refractory disease * No prior tumor-related hemorrhage (any grade) * Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan * No CNS disease, brain metastases, or primary brain tumors PATIENT CHARACTERISTICS: * ECOG performance status of 0 or 1 * Absolute granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9 gm/dL (transfusion and epoetin alfa allowed) * Creatinine ≤ 1.5 times upper limit of normal (ULN) * Urine protein:creatinine ratio ≤ 1.0 * Total bilirubin ≤ 1.5 mg/dL * Aspartate aminotransferase \< 5 times ULN * Alkaline phosphatase \< 5 times ULN * PT/INR ≤ 1.5 times ULN * PTT ≤ 1.5 times ULN * Fertile patients must use effective contraception * Ejection fraction \> 49% for patients with prior anthracycline therapy, ischemic cardiac disease, or history of heart failure * No uncontrolled active infection * No uncontrolled high blood pressure (defined as \> 150/100 mm Hg) * No symptomatic congestive heart failure (New York Heart Association class II-IV), unstable angina, cardiac arrhythmia, or myocardial infarction within the past 6 months * No psychiatric illness or social situation that would limit study compliance * No serious, nonhealing wound, ulcer, or bone fracture * No evidence of bleeding diathesis or coagulopathy * No clinically significant peripheral vascular disease * Not pregnant or nursing * No seizures not controlled with standard medical therapy * No embolic or hemorrhagic stroke or prior transient ischemic attack * No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months * No significant traumatic injury within the past 6 weeks PRIOR CONCURRENT THERAPY: * No prior therapy with bevacizumab or other antiangiogenesis treatment * No major surgical procedure or open biopsy within the past 6 weeks * No more than 2 prior chemotherapy regimens * No fine-needle aspiration or core-needle biopsy or other minor surgical procedure within the past 7 days * No radiotherapy within the past 28 days * No concurrent chronic daily treatment with aspirin \> 325 mg/day or nonsteroidal anti-inflammatory medications * No concurrent warfarin or any other anticoagulant (any dose) * No concurrent radiotherapy * No concurrent major surgery

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Northwestern University: lead
• Genentech, Inc.: collaborator

Study Sites (5)

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, 92093-0658, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Fox Chase Cancer Center CCOP Research Base

Philadelphia, Pennsylvania, 19140, United States

Location

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

MeSH Terms

Conditions

Sarcoma; Hemangiosarcoma

Interventions

Bevacizumab; Vascular Endothelial Growth Factor A

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Vascular Endothelial Growth Factors; Angiogenic Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Biological Factors

Results Point of Contact

• Title: Mark Agulnik, MD
• Organization: Northwestern University

magulnik@nm.org

312-695-6182

Study Officials

• Mark Agulnik, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 6, 2006
• First Posted: February 7, 2006
• Study Start: October 1, 2005
• Primary Completion: June 6, 2013
• Study Completion: November 10, 2016
• Last Updated: June 25, 2018
• Results First Posted: June 25, 2018

Record last verified: 2018-06

Locations

US (5)