Doxorubicin and Bevacizumab in Treating Patients With Locally Recurrent or Metastatic Soft Tissue Sarcoma

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