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Phase II Study of Doxorubicin and Avastin® for Patients With Advanced Soft-tissue Sarcomas.


Phase 2
18 Years
N/A
Not Enrolling
Both
Sarcoma, Soft Tissue Sarcoma

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Trial Information

Phase II Study of Doxorubicin and Avastin® for Patients With Advanced Soft-tissue Sarcomas.


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

RECIST

Outcome Time Frame:

6 month PFS

Safety Issue:

Yes

Principal Investigator

Katherine A Thornton, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins SKCCC

Authority:

United States: Food and Drug Administration

Study ID:

J07133

NCT ID:

NCT00755261

Start Date:

September 2008

Completion Date:

Related Keywords:

  • Sarcoma
  • Soft Tissue Sarcoma
  • STS
  • Sarcoma

Name

Location

Johns Hopkins SKCCCBaltimore, Maryland  21231