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Doxorubicin and Bevacizumab in Treating Patients With Locally Recurrent or Metastatic Soft Tissue Sarcoma

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ClinicalTrials.gov Identifier: NCT00052390
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 24, 2013
Information provided by:

Study Description
Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bevacizumab may stop the growth of tumor cells by stopping blood flow to the tumor. Combining doxorubicin with bevacizumab may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining doxorubicin with bevacizumab in treating patients who have locally recurrent or metastatic soft tissue sarcoma.

Condition or disease Intervention/treatment Phase
Sarcoma Biological: bevacizumab Drug: doxorubicin hydrochloride Phase 2

Detailed Description:


  • Determine the response rate (partial and complete) in patients with locally recurrent or metastatic soft tissue sarcoma treated with doxorubicin and bevacizumab.
  • Determine the tolerability of this regimen in these patients.
  • Determine the toxicity profile of this regimen in these patients.
  • Determine whether pre-treatment plasma vascular endothelial growth factor level or microvessel density of tumor samples from these patients predicts response to this regimen.

OUTLINE: This is a multicenter study.

Patients receive doxorubicin IV over 5-10 minutes followed by bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with responding disease after reaching the maximum dose of doxorubicin may continue bevacizumab alone.

Patients are followed every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 17-37 patients will be accrued for this study within 13.3 months.

Study Design

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Institutional, Open-Label, Phase II Study Of Doxorubicin And Bevacizumab (Anti-VEFG Monoclonal Antibody, NSC 704865) For Patients With Advanced Or Metastatic Soft-Tissue Sarcoma
Study Start Date : October 2002
Study Completion Date : October 2005

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed soft tissue sarcoma

    • Locally recurrent or metastatic disease
  • At least 1 unidimensionally measurable lesion

    • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • No prior or concurrent known brain metastases



  • 18 and over

Performance status

  • Karnofsky 80-100% OR
  • ECOG 0-1

Life expectancy

  • Not specified


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • No bleeding diathesis or coagulopathy


  • Bilirubin no greater than 1.2 mg/dL
  • AST and ALT no greater than 2.5 times upper limit of normal
  • PT and aPTT normal


  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min
  • No proteinuria (must be less than 500 mg protein per 24 hours)


  • Cardiac ejection fraction at least 50% by echocardiogram or MUGA
  • No history of deep vein thrombosis
  • No clinically significant cardiovascular disease
  • No uncontrolled hypertension
  • No myocardial infarction
  • No unstable angina
  • No New York Heart Association grade II-IV congestive heart failure
  • No serious cardiac arrhythmia requiring medication
  • No grade II or greater peripheral vascular disease within the past year


  • No history of pulmonary embolism


  • No symptomatic peripheral neuropathy grade 2 or greater
  • No other neoplastic disease within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix
  • No prior allergic reactions attributed to compounds of similar chemical or biological composition to bevacizumab (including products derived from Chinese hamster ovary cells), doxorubicin, or dexrazoxane
  • No HIV-positive patients receiving combination antiretroviral therapy
  • No ongoing or active infection
  • No psychiatric illness or social situations that would preclude study entry
  • No other uncontrolled concurrent illness
  • No serious, non-healing wound ulcer or bone fracture
  • No significant traumatic injury within the past 3 weeks
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy

  • See Chemotherapy
  • At least 4 weeks since prior immunotherapy and recovered
  • No other concurrent immunotherapy


  • No prior doxorubicin or any other anthracyclines
  • No more than 1 prior chemotherapy regimen

    • The following are not considered prior chemotherapy:

      • Immunotherapy, including cytokines
      • Peroxisome-proliferator-activated receptor gamma agonists or thalidomide
  • At least 4 weeks since prior chemotherapy (6 weeks for carmustine or mitomycin) and recovered
  • No other concurrent chemotherapy

Endocrine therapy

  • Not specified


  • At least 4 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy


  • At least 3 weeks since prior major surgical procedure or open biopsy
  • At least 1 week since prior needle biopsy


  • No other concurrent investigational agents
  • No concurrent full-dose anticoagulants (except to maintain patency of preexisting, permanent indwelling IV catheters) or thrombolytic agent

    • Concurrent warfarin allowed if INR less than 1.5
  • No concurrent chronic daily aspirin (more than 325 mg/day) or nonsteroidal anti -inflammatory medications known to inhibit platelet function
  • No other concurrent investigational or commercial agents or therapies for this malignancy
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00052390

United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Robert Maki, MD, PhD Memorial Sloan Kettering Cancer Center
More Information

ClinicalTrials.gov Identifier: NCT00052390     History of Changes
Other Study ID Numbers: CDR0000258249
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 24, 2013
Last Verified: February 2004

Keywords provided by National Cancer Institute (NCI):
recurrent adult soft tissue sarcoma
stage III adult soft tissue sarcoma
stage IV adult soft tissue sarcoma

Additional relevant MeSH terms:
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Liposomal doxorubicin
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action