Phase II Study of Doxorubicin and Avastin® in Sarcoma.

NCT00755261 | Terminated Phase 2 Results DMC

• 3 other identifiers: J07133NA_00013238AVF3855s
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoma; Soft Tissue Sarcoma

Keywords

STS

Outcome Measures

Primary Outcomes (1)

• RECIST

  Study was terminated because of low accrual.

  6 month PFS

Study Arms (1)

Avastin and Doxorubicin

EXPERIMENTAL

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

Avastin DRUG

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

Avastin and Doxorubicin

Doxorubicin DRUG

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

Also known as: Adriamycin

Avastin and Doxorubicin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

Johns Hopkins SKCCC

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Sarcoma

Interventions

Bevacizumab; Doxorubicin

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Results Point of Contact

• Title: Christian Meyer, M.D., Ph.D.
• Organization: SKCCC, Johns Hopkins University

cmeyer13@jhmi.edu

4105025940

Study Officials

• Katherine A Thornton, MD

  Johns Hopkins SKCCC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2008
• First Posted: September 18, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: November 1, 2010
• Last Updated: May 8, 2015
• Results First Posted: May 8, 2015

Record last verified: 2015-05

Locations

US (1)