NCT00052390

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bevacizumab may stop the growth of tumor cells by stopping blood flow to the tumor. Combining doxorubicin with bevacizumab may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining doxorubicin with bevacizumab in treating patients who have locally recurrent or metastatic soft tissue sarcoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Oct 2002

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

June 24, 2013

Status Verified

February 1, 2004

First QC Date

January 24, 2003

Last Update Submit

June 21, 2013

Conditions

Sarcoma

Keywords

recurrent adult soft tissue sarcomastage III adult soft tissue sarcomastage IV adult soft tissue sarcoma

Interventions

bevacizumabBIOLOGICAL
doxorubicin hydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed soft tissue sarcoma * Locally recurrent or metastatic disease * At least 1 unidimensionally measurable lesion * At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan * No prior or concurrent known brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 80-100% OR * ECOG 0-1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * No bleeding diathesis or coagulopathy Hepatic * Bilirubin no greater than 1.2 mg/dL * AST and ALT no greater than 2.5 times upper limit of normal * PT and aPTT normal Renal * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance at least 60 mL/min * No proteinuria (must be less than 500 mg protein per 24 hours) Cardiovascular * Cardiac ejection fraction at least 50% by echocardiogram or MUGA * No history of deep vein thrombosis * No clinically significant cardiovascular disease * No uncontrolled hypertension * No myocardial infarction * No unstable angina * No New York Heart Association grade II-IV congestive heart failure * No serious cardiac arrhythmia requiring medication * No grade II or greater peripheral vascular disease within the past year Pulmonary * No history of pulmonary embolism Other * No symptomatic peripheral neuropathy grade 2 or greater * No other neoplastic disease within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix * No prior allergic reactions attributed to compounds of similar chemical or biological composition to bevacizumab (including products derived from Chinese hamster ovary cells), doxorubicin, or dexrazoxane * No HIV-positive patients receiving combination antiretroviral therapy * No ongoing or active infection * No psychiatric illness or social situations that would preclude study entry * No other uncontrolled concurrent illness * No serious, non-healing wound ulcer or bone fracture * No significant traumatic injury within the past 3 weeks * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * See Chemotherapy * At least 4 weeks since prior immunotherapy and recovered * No other concurrent immunotherapy Chemotherapy * No prior doxorubicin or any other anthracyclines * No more than 1 prior chemotherapy regimen * The following are not considered prior chemotherapy: * Immunotherapy, including cytokines * Peroxisome-proliferator-activated receptor gamma agonists or thalidomide * At least 4 weeks since prior chemotherapy (6 weeks for carmustine or mitomycin) and recovered * No other concurrent chemotherapy Endocrine therapy * Not specified Radiotherapy * At least 4 weeks since prior radiotherapy and recovered * No concurrent radiotherapy Surgery * At least 3 weeks since prior major surgical procedure or open biopsy * At least 1 week since prior needle biopsy Other * No other concurrent investigational agents * No concurrent full-dose anticoagulants (except to maintain patency of preexisting, permanent indwelling IV catheters) or thrombolytic agent * Concurrent warfarin allowed if INR less than 1.5 * No concurrent chronic daily aspirin (more than 325 mg/day) or nonsteroidal anti -inflammatory medications known to inhibit platelet function * No other concurrent investigational or commercial agents or therapies for this malignancy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

  • D'Adamo DR, Anderson SE, Albritton K, Yamada J, Riedel E, Scheu K, Schwartz GK, Chen H, Maki RG. Phase II study of doxorubicin and bevacizumab for patients with metastatic soft-tissue sarcomas. J Clin Oncol. 2005 Oct 1;23(28):7135-42. doi: 10.1200/JCO.2005.16.139.

    PMID: 16192597RESULT

MeSH Terms

Conditions

Sarcoma

Interventions

BevacizumabDoxorubicin

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Robert Maki, MD, PhD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 24, 2003

First Posted

January 27, 2003

Study Start

October 1, 2002

Study Completion

October 1, 2005

Last Updated

June 24, 2013

Record last verified: 2004-02

Locations

US(3)