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A Multi-Institutional, Open-Label, Phase II Study Of Doxorubicin And Bevacizumab (Anti-VEFG Monoclonal Antibody, NSC 704865) For Patients With Advanced Or Metastatic Soft-Tissue Sarcoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Sarcoma

Thank you

Trial Information

A Multi-Institutional, Open-Label, Phase II Study Of Doxorubicin And Bevacizumab (Anti-VEFG Monoclonal Antibody, NSC 704865) For Patients With Advanced Or Metastatic Soft-Tissue Sarcoma


OBJECTIVES:

- Determine the response rate (partial and complete) in patients with locally recurrent
or metastatic soft tissue sarcoma treated with doxorubicin and bevacizumab.

- Determine the tolerability of this regimen in these patients.

- Determine the toxicity profile of this regimen in these patients.

- Determine whether pre-treatment plasma vascular endothelial growth factor level or
microvessel density of tumor samples from these patients predicts response to this
regimen.

OUTLINE: This is a multicenter study.

Patients receive doxorubicin IV over 5-10 minutes followed by bevacizumab IV over 30-90
minutes on day 1. Courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity. Patients with responding disease after reaching the maximum dose of
doxorubicin may continue bevacizumab alone.

Patients are followed every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 17-37 patients will be accrued for this study within 13.3
months.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Robert Maki, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000258249

NCT ID:

NCT00052390

Start Date:

October 2002

Completion Date:

October 2005

Related Keywords:

  • Sarcoma
  • recurrent adult soft tissue sarcoma
  • stage III adult soft tissue sarcoma
  • stage IV adult soft tissue sarcoma
  • Sarcoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115