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TerminatedNCT00755261Updated May 8, 2015Results posted

Phase II Study of Doxorubicin and Avastin® in Sarcoma.

A Phase 2 interventional study of Avastin and Doxorubicin in Sarcoma and Soft Tissue Sarcoma, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-08.

Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Phase 2, Interventional, and Treatment

Why this study was terminated
The study has been terminated due to low accrual.
Phase
Phase 2
Study type
Interventional
Enrollment
4
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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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Conditions studied

  • Sarcoma
  • Soft Tissue Sarcoma

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Keywords

  • STS
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In context

Sarcoma

1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.

This study's enrollment of 4 is below the median of 40 across 1,283 interventional studies indexed under Sarcoma.

Browse Sarcoma studies →

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is the lead sponsor of 572 studies on the registry; 73 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 67 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • 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 · Drug: Doxorubicin

Interventions

  • DrugAvastin

    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.

    Also known as: bevacizumab

  • DrugDoxorubicin

    The Day 1 6- hour continuous IV infusion must be done through a central venous catheter.

    Also known as: Adriamycin

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What researchers measure

Primary outcomes

  1. RECIST

    Study was terminated because of low accrual.

    Time frame: 6 month PFS

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Results

Posted May 8, 2015

Participant flow

Only 4 subjects were accrued over 2 years. Study was closed due to slow accrual.

Participant flow — Overall Study
MilestoneAvastin and Doxorubicin
Started6
Completed4
Not completed2

Outcome measures

PrimaryRECIST

Study was terminated because of low accrual.

Time frame:
6 month PFS

No measurements were reported for this outcome.

Adverse events

Collected over none, study was terminated early because of low accrual.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Avastin and Doxorubicin—2/4 (50%)1/4 (25%)
Most frequent serious events
Most frequent serious events
EventAvastin and Doxorubicin
febrile neutropeniaBlood and lymphatic system disorders1/4
acute renal failureRenal and urinary disorders1/4
Most frequent other events
Most frequent other events
EventAvastin and Doxorubicin
thrushInfections and infestations1/4
dehydrationMetabolism and nutrition disorders1/4
dysphagia -unable to swallow medicationsGastrointestinal disorders1/4

Baseline characteristics

Age, Continuous
Age, Continuous(years)Avastin and Doxorubicin
Median58 (45 to 65)
Sex: Female, Male
Sex: Female, Male(Participants)Avastin and Doxorubicin
Female2
Male4
Region of Enrollment
Region of Enrollment(participants)Avastin and Doxorubicin
United States6
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Study locations

1 site
  • Johns Hopkins SKCCC
    Baltimore, Maryland 21231, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00755261
Lead sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Responsible party
Sponsor
First posted
Sep 18, 2008
Start date
Sep 2008
Primary completion
Sep 2010
Completion
Nov 2010
Results posted
May 8, 2015
Last update
May 8, 2015

Study contacts

Katherine A Thornton, MD
principal investigator · Johns Hopkins SKCCC

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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