Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Phase II Study of Doxorubicin and Avastin® in Sarcoma.

This study has been terminated.
(The study has been terminated due to low accrual.)
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00755261
First received: September 17, 2008
Last updated: June 11, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Sarcoma
Soft Tissue Sarcoma
Drug: Avastin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Doxorubicin and Avastin® for Patients With Advanced Soft-tissue Sarcomas.

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • RECIST [ Time Frame: 6 month PFS ] [ Designated as safety issue: Yes ]

Enrollment: 4
Study Start Date: September 2008
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Avastin
    combination of Avastin and doxorubicin
    Other Names:
    • Adriamycin
    • Avastin
    • bevacizumab
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00755261

Locations
United States, Maryland
Johns Hopkins SKCCC
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Katherine A Thornton, MD Johns Hopkins SKCCC
  More Information

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00755261     History of Changes
Other Study ID Numbers: J07133, NA_00013238
Study First Received: September 17, 2008
Last Updated: June 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
STS

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

ClinicalTrials.gov processed this record on November 19, 2014