Bevacizumab and Paclitaxel for Neuroendocrine Tumors of the Cervix
A Phase II Evaluation of Bevacizumab and Paclitaxel in Patients With Recurrent Small Cell, Large Cell, and Neuroendocrine Tumors of the Cervix and Uterus
Objectives:
Primary:
To estimate the efficacy of bevacizumab and paclitaxel in patients with recurrent small cell, large cell, and neuroendocrine cervical and uterine cancers, as measured by progression-free survival.
Secondary:
- To estimate the efficacy of bevacizumab and paclitaxel in patients with recurrent small cell, large cell, and neuroendocrine cervical and uterine cancers, as measured by overall survival.
- To determine the response rates in patients with recurrent small cell, large cell, and neuroendocrine cervical and uterine cancers when treated with bevacizumab and paclitaxel.
- To characterize the quality of life (QoL) in patients with recurrent small cell, large cell, and neuroendocrine cervical and uterine cancers when treated with bevacizumab and paclitaxel.
- To determine the nature and degree of toxicity in patients with advanced or recurrent small cell, large cell, or neuroendocrine cervical and uterine cancers when treated with bevacizumab and paclitaxel.
調査の概要
詳細な説明
The Study Drugs:
Paclitaxel is designed to block the mechanisms of cell division in cancer cells, which may cause them to die.
Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the effects of Vascular endothelial growth factor (VEGF), a blood-vessel stimulating agent that plays an important role in the growth of both normal and abnormal blood vessels.
Study Drug Administration:
If you are found to be eligible to take part in this study, on Days 1, 8, 15, and 22 of each 28-day study "cycle", you will receive paclitaxel through a needle into your vein over 1 hour.
On Days 1 and 15 of each cycle, you will receive bevacizumab by vein. The first dose of bevacizumab will be given over about 90 minutes. If the first dose is well tolerated, the second dose may be given over about 60 minutes. If this is well tolerated, the third and any other doses may be given over about 30 minutes.
Before you receive the study drugs, you will receive premedication (selected by your doctor) to help prevent or lessen any side effects from the study drugs.
Study Visits:
About every 4 weeks, the following tests and procedures will be performed:
- You will have a physical exam, including a pelvic exam and measurement of your vital signs.
- You will have a performance status evaluation.
- Blood (about 2-3 teaspoons) will be drawn for routine tests and to test how your blood clots.
- You will be asked if you have experienced any side effects.
About every 8 weeks, you will have a chest x-ray and a computed tomography (CT) or magnetic resonance imaging (MRI) scan of your abdomen and pelvis to check the status of the disease.
Length of Study:
You may stay on study for as long as you are benefitting. You will be taken off study early if the disease gets worse or you experience intolerable side effects.
End-of-Study Visit:
After you go off study, you will have an end-of-study visit. At this visit, the following tests and procedures will be performed:
- You will have a physical exam, including a pelvic exam and measurement of your vital signs.
- You will have a performance status evaluation.
- Blood (about 2-3 teaspoons) will be drawn for routine tests and possibly blood clotting tests.
- You will have a CT or MRI of the abdomen and pelvis to check the status of the disease.
- You will be asked if you have experienced any side effects.
This is an investigational study. Paclitaxel is FDA approved and commercially available for the treatment of breast cancer, nonsmall cell lung cancer, ovarian cancers, and treatment of AIDS-related Kaposi's sarcoma (KS). Bevacizumab is FDA approved and commercially available for use in combination with chemotherapy in patients with colon cancer, but its use in this combination for this type of cancer is considered experimental.
Up to 20 participants will take part in this study. All will be enrolled at M. D. Anderson.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
-
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Texas
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Houston、Texas、アメリカ、77030
- UT MD Anderson Cancer Center
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Patients with histologically confirmed, advanced stage (stage IVB), recurrent, or persistent small cell, large cell, or neuroendocrine tumor of the uterine corpus and cervix
- All patients must have measurable disease. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be > / = 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or > / = 10 mm when measured by spiral CT. Biopsy confirmation is required if the lesion measures < 30 mm or if the treating physician determines it is clinically indicated.
- Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by Response Evaluation Criteria in Solid Tumors (RECIST). Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.
- Patients must have adequate: BONE MARROW FUNCTION: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl and platelets greater than or equal to 100,000/mcl. RENAL FUNCTION: Creatinine less than or equal to 1.5 * institutional upper limit normal (ULN), and measured or estimated creatinine clearance greater than or equal to 50 ml/min. For the purpose of estimating the creatinine clearance, the formula of Jelliffe should be utilized. HEPATIC FUNCTION: Bilirubin less than or equal to 1.5 * ULN. serum glutamate oxaloacetate transaminase (SGOT) and alkaline phosphatase less than or equal to 2.5 * ULN
- Patients must have adequate: BLOOD COAGULATION PARAMETERS: prothrombin time (PT) such that international normalized ratio (INR) is < / = 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a partial thromboplastin time (PTT) < 1.2 times the upper limit of normal. NEUROLOGIC FUNCTION: Neuropathy (sensory and motor) less than or equal to [1] Common Toxicity Criteria for Adverse Effects (CTCAE) grade 1.
- Patients must have signed an approved informed consent and authorization permitting release of personal health information.
- Patients with Eastern Cooperative Oncology Group (ECOG) Performance Grade of 0 or 1
- Patients must be free of clinically significant infection.
Exclusion Criteria:
- Patients who have progressed through or recurred within 3 months of treatment with a taxane agent administered on a weekly basis.
- Patients who have previously been treated with bevacizumab or other anti-angiogenic agents
- Patients who are less than 4 weeks from prior chemotherapy and/or radiation therapy
- Patients with ECOG Performance Grade of 2, 3 or 4
- Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last 5 years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
- Subjects meeting any of the following criteria are ineligible for study entry: (a) Inability to comply with study and/or follow-up procedures (b) Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study
- Inadequately controlled hypertension (defined as systolic blood pressure >140 or diastolic blood pressure > 90 mmHg on antihypertensive medications)
- Any prior history of hypertensive crisis or hypertensive encephalopathy
- New York Heart Association (NYHA) Grade II or greater congestive heart failure
- History of myocardial infarction or unstable angina within 6 months prior to study enrollment
- History of stroke or transient ischemic attack within 6 months prior to study enrollment
- Known metastatic cervical cancer to the central nervous system
- Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
- Symptomatic peripheral vascular disease
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study
- Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
- Serious, non-healing wound, ulcer, or bone fracture
- Proteinuria at screening as demonstrated by urine dipstick for proteinuria > / = 2+ (patients discovered to have > / = 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate < / = 1g of protein in 24 hours to be eligible)
- Known hypersensitivity to any component of bevacizumab
- Pregnant (positive pregnancy test) or lactating
- Patients receiving black cohosh, dong quai, valerian, St. John's wort, kava kava, gotu kola. Patient cannot have received these medications within 14 days of therapy start.
- Patients with a known hypersensitivity to taxanes, Cremophor EL (polyoxyethylated castor oil), or any component of the formulation.
- History of hemoptysis (>/= ½ teaspoon of bright red blood per episode) within 1 month prior to Day 1
- Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
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
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:Bevacizumab + Paclitaxel
Bevacizumab 10 mg/kg intravenous (IV) twice weekly and Paclitaxel 60 mg/m^2 IV weekly.
|
10 mg/kg IV twice weekly on days 1 and 15.
他の名前:
60 mg/m^2 IV weekly on days 1, 8, 15, and 22.
他の名前:
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Progression-free Survival (PFS)
時間枠:Baseline to 6 Months, or until disease progression.
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Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.
|
Baseline to 6 Months, or until disease progression.
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協力者と研究者
協力者
捜査官
- 主任研究者:Michael M. Frumovitz, MD、UT MD Anderson Cancer Center
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
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
追加の関連 MeSH 用語
その他の研究ID番号
- 2007-0324
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
子宮頸癌の臨床試験
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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); Highlight Therapeutics積極的、募集していない平滑筋肉腫 | 悪性末梢神経鞘腫瘍 | 滑膜肉腫 | 未分化多形肉腫 | 骨の未分化高悪性度多形肉腫 | 粘液線維肉腫 | II期の体幹および四肢の軟部肉腫 AJCC v8 | III期の体幹および四肢の軟部肉腫 AJCC v8 | IIIA 期の体幹および四肢の軟部肉腫 AJCC v8 | IIIB 期の体幹および四肢の軟部肉腫 AJCC v8 | 切除可能な軟部肉腫 | 多形性横紋筋肉腫 | 切除可能な脱分化型脂肪肉腫 | 切除可能な未分化多形肉腫 | 軟部組織線維肉腫 | 紡錘細胞肉腫 | ステージ I 後腹膜肉腫 AJCC (American Joint Committee on Cancer) v8 | 体幹および四肢の I 期軟部肉腫 AJCC v8 | ステージ... およびその他の条件アメリカ
Bevacizumabの臨床試験
-
Weill Medical College of Cornell University終了しました多形性膠芽腫 | 退形成性星細胞腫 | びまん性内因性橋グリオーマ | 脳幹グリオーマ | 毛包粘液性星細胞腫 | 脳幹の神経膠腫 | 脳の線維性星細胞腫 | 混合乏突起膠腫-星細胞腫アメリカ