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

Primary Purpose

Sarcoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bevacizumab
doxorubicin hydrochloride
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring recurrent adult soft tissue sarcoma, stage III adult soft tissue sarcoma, stage IV adult soft tissue sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 80-100% OR ECOG 0-1 Life expectancy Not specified Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 No bleeding diathesis or coagulopathy Hepatic 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 Renal 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) Cardiovascular 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 Pulmonary No history of pulmonary embolism Other 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 PRIOR CONCURRENT THERAPY: Biologic therapy See Chemotherapy At least 4 weeks since prior immunotherapy and recovered No other concurrent immunotherapy Chemotherapy 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 Radiotherapy At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery At least 3 weeks since prior major surgical procedure or open biopsy At least 1 week since prior needle biopsy Other 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

Sites / Locations

  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
  • Memorial Sloan-Kettering Cancer Center
  • Huntsman Cancer Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 24, 2003
Last Updated
June 21, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00052390
Brief Title
Doxorubicin and Bevacizumab in Treating Patients With Locally Recurrent or Metastatic Soft Tissue Sarcoma
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 Type
Interventional

2. Study Status

Record Verification Date
February 2004
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. 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.
Detailed Description
OBJECTIVES: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
recurrent adult soft tissue sarcoma, stage III adult soft tissue sarcoma, stage IV adult soft tissue sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
bevacizumab
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: 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 PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 80-100% OR ECOG 0-1 Life expectancy Not specified Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 No bleeding diathesis or coagulopathy Hepatic 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 Renal 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) Cardiovascular 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 Pulmonary No history of pulmonary embolism Other 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 PRIOR CONCURRENT THERAPY: Biologic therapy See Chemotherapy At least 4 weeks since prior immunotherapy and recovered No other concurrent immunotherapy Chemotherapy 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 Radiotherapy At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery At least 3 weeks since prior major surgical procedure or open biopsy At least 1 week since prior needle biopsy Other 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Maki, MD, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16192597
Citation
D'Adamo DR, Anderson SE, Albritton K, Yamada J, Riedel E, Scheu K, Schwartz GK, Chen H, Maki RG. Phase II study of doxorubicin and bevacizumab for patients with metastatic soft-tissue sarcomas. J Clin Oncol. 2005 Oct 1;23(28):7135-42. doi: 10.1200/JCO.2005.16.139.
Results Reference
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Doxorubicin and Bevacizumab in Treating Patients With Locally Recurrent or Metastatic Soft Tissue Sarcoma

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