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

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bevacizumab; Doxorubicin; Liposomal doxorubicin

Criteria

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