Doxorubicin and Bevacizumab in Treating Patients With Locally Recurrent or Metastatic Soft Tissue Sarcoma
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
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.
調査の概要
詳細な説明
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.
研究の種類
段階
- フェーズ2
連絡先と場所
研究場所
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Massachusetts
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Boston、Massachusetts、アメリカ、02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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New York
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New York、New York、アメリカ、10021
- Memorial Sloan-Kettering Cancer Center
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Utah
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Salt Lake City、Utah、アメリカ、84112
- Huntsman Cancer Institute
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- マスキング:なし(オープンラベル)
協力者と研究者
捜査官
- スタディチェア:Robert Maki, MD, PhD、Memorial Sloan Kettering Cancer Center
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- CDR0000258249
- MSKCC-02041
- NCI-2270
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