Status:
TERMINATED
Phase II Study of Doxorubicin and Avastin® in Sarcoma.
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Conditions:
Sarcoma
Soft Tissue Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 progre...
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 a...
Eligibility Criteria
Inclusion
- Pathologically confirmed intermediate or high grade locally advanced or metastatic soft tissue sarcoma.
- The presence of measurable disease
- Normal renal function (spot dipstick \<2\*\* or urine protein: creatinine ratio \>1.0
- Normal Hepatic function (total bilirubin within JOHC normal limits, transaminases (AST and ALT \<3 times upper limit of normal
- Hematologic parameters as defined as ANC \>1500/mm³ and Platelets \> 100,000/mm³.
- Performance status 0-1 on ECOG scale
- Use of effective means of contraception (men and women) in subjects of child-bearing age
- No prior use of mesna, adriamycin, ifosfamide or Avastin®.
- Baseline ECHO or MUGA with LVEF \> or = 50-60%.
- Age ≥ 18
Exclusion
- Major surgery within 28 days
- History of proteinuria \> 1+
- 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
- Inadequately controlled hypertension (defined as systolic blood pressure \>150 and/or diastolic blood pressure \> 100 mmHg on antihypertensive medications)
- Any prior history of hypertensive crisis or hypertensive encephalopathy
- New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix E)
- History of myocardial infarction or unstable angina within 6 months prior to study enrollment
- History of stroke or transient ischemic attack within 6 months prior to study enrollment
- Symptomatic peripheral vascular disease
- Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
- Evidence of bleeding diathesis or coagulopathy
- Current or recent (within 10 days of enrollment) use of aspirin (\>325 mg/day) or chronic use of other NSAIDs
- Current, ongoing treatment with full-dose warfarin or its equivalent (i.e., unfractionated and/or low molecular weight heparin).
- Known central nervous system or brain metastases
- 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
- Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment
- Pregnant (positive pregnancy test) or lactating
- 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).
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
- Serious, non-healing wound, ulcer, or bone fracture
- Known hypersensitivity to any component of Avastin®
- Inability to comply with study and/or follow-up procedures
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00755261
Start Date
September 1 2008
End Date
November 1 2010
Last Update
May 8 2015
Active Locations (1)
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1
Johns Hopkins SKCCC
Baltimore, Maryland, United States, 21231