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Phase II Study of Doxorubicin and Avastin® in Sarcoma.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00755261
Recruitment Status : Terminated (The study has been terminated due to low accrual.)
First Posted : September 18, 2008
Results First Posted : May 8, 2015
Last Update Posted : May 8, 2015
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:
This research is being done to find out if adding a drug called Avastin to an already approved regimen used for soft-tissue sarcoma, Doxorubicin, will improve overall survival, and slow disease progression. The study will also evaluate the overall safety of combining these drugs. It is not known if combining these drugs will improve outcome. Avastin has been approved for the treatment of metastatic carcinoma of the colon or rectum. It is not approved for the treatment of soft-tissue sarcoma when added to Doxorubicin.

Condition or disease Intervention/treatment Phase
Sarcoma Soft Tissue Sarcoma Drug: Avastin Drug: Doxorubicin Phase 2

Detailed Description:
The rationale for this trial is to improve the efficacy of prototypical anti-sarcoma chemotherapeutic regimen Doxorubicin when combined with Avastin®. Soft tissue sarcomas are highly vascular tumors and are therefore ideally suited to trials combining angiogenic inhibitors with chemotherapy. Several studies have revealed correlations between prognosis and surrogates for angiogenesis, including microvessel density, and circulating VEGF and basic fibroblast growth factor (bFGF). The aim of this study is to evaluate the safety and efficacy of Avastin® in combination with Doxorubicin for the treatment of advanced soft-tissue sarcomas.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Doxorubicin and Avastin® for Patients With Advanced Soft-tissue Sarcomas.
Study Start Date : September 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : November 2010

Arm Intervention/treatment
Experimental: Avastin and Doxorubicin
Patients will be treated with Avastin 15 mg/kg IV infusion plus doxorubicin 60 mg/M2 (body surface area) IV 6-hour infusion on Day 1 of each 21-day treatment cycle. Dose reductions/modifications will be applied as indicated by toxicities and/or patient tolerance.
Drug: Avastin
Combination of Avastin and doxorubicin. If initial 90 +/- 15 minute infusion of Avastin is tolerated without fever and chills, the 2nd dose may be infused over 60 +/- 10 minutes. If well tolerated, all subsequent infusions may be delivered over 30 +/- 10 minutes.
Other Name: bevacizumab

Drug: Doxorubicin
The Day 1 6- hour continuous IV infusion must be done through a central venous catheter.
Other Name: Adriamycin

Primary Outcome Measures :
  1. RECIST [ Time Frame: 6 month PFS ]
    Study was terminated because of low accrual.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  1. Pathologically confirmed intermediate or high grade locally advanced or metastatic soft tissue sarcoma.
  2. The presence of measurable disease
  3. Normal renal function (spot dipstick <2** or urine protein: creatinine ratio >1.0
  4. Normal Hepatic function (total bilirubin within JOHC normal limits, transaminases (AST and ALT <3 times upper limit of normal
  5. Hematologic parameters as defined as ANC >1500/mm³ and Platelets > 100,000/mm³.
  6. Performance status 0-1 on ECOG scale
  7. Use of effective means of contraception (men and women) in subjects of child-bearing age
  8. No prior use of mesna, adriamycin, ifosfamide or Avastin®.
  9. Baseline ECHO or MUGA with LVEF > or = 50-60%.
  10. Age ≥ 18

Exclusion Criteria:

  1. Major surgery within 28 days
  2. History of proteinuria > 1+
  3. Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored Avastin® cancer study
  4. Inadequately controlled hypertension (defined as systolic blood pressure >150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications)
  5. Any prior history of hypertensive crisis or hypertensive encephalopathy
  6. New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix E)
  7. History of myocardial infarction or unstable angina within 6 months prior to study enrollment
  8. History of stroke or transient ischemic attack within 6 months prior to study enrollment
  9. Symptomatic peripheral vascular disease
  10. Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
  11. Evidence of bleeding diathesis or coagulopathy
  12. Current or recent (within 10 days of enrollment) use of aspirin (>325 mg/day) or chronic use of other NSAIDs
  13. Current, ongoing treatment with full-dose warfarin or its equivalent (i.e., unfractionated and/or low molecular weight heparin).
  14. Known central nervous system or brain metastases
  15. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
  16. Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment
  17. Pregnant (positive pregnancy test) or lactating
  18. Proteinuria :creatinine (UPC) ratio ≥ 1.0 at screening or Urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible).
  19. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
  20. Serious, non-healing wound, ulcer, or bone fracture
  21. Known hypersensitivity to any component of Avastin®
  22. Inability to comply with study and/or follow-up procedures

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 identifier (NCT number): NCT00755261

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United States, Maryland
Johns Hopkins SKCCC
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Principal Investigator: Katherine A Thornton, MD Johns Hopkins SKCCC
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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Identifier: NCT00755261    
Other Study ID Numbers: J07133
NA_00013238 ( Other Identifier: Johns Hopkins University IRB )
AVF3855s ( Other Identifier: Genentech, Inc )
First Posted: September 18, 2008    Key Record Dates
Results First Posted: May 8, 2015
Last Update Posted: May 8, 2015
Last Verified: May 2015
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
Additional relevant MeSH terms:
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Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action