Efficacy/Safety Study of Bevacizumab,Capecitabine,Oxaliplatin to Metastatic Colorectal Adenocarcinoma Elderly Patients. (BECOX)
A Non Randomized Phase II Trial to Assess Efficacy and Safety of Bevacizumab, Capecitabine and Oxaliplatin as First Line Treatment for Elderly Patients With Metastatic Colorectal Adenocarcinoma, Suitable for Polychemotherapy Treatment
調査の概要
詳細な説明
The efficacy will be determined by objective response rate following RECIST criteria.
In several clinical trials with Bevacizumab, there has been demonstrated that elderly patients benefits as well as the younger of a combination therapy with chemotherapy plus Bevacizumab, but these results have come from subgroup analyses of trials not specifically design to test the effect of these combinations on the elderly. This clinical trial is specific only for elderly patients and we expect to confirm the benefits demonstrated in other clinical trials where the elderly patients were a number reduced.
This clinical trial includes 3 substudies:
- Assessment of tumor response of CRC liver metastases to treatment with Avastin in combination with Capecitabine and Oxaliplatin as first line treatment by dynamic ultrasound contrast.
Main objective: Assess the performance of dynamic contrast ultrasonography (CEUS, Contrast Enhanced UltraSound) with quantification of tumor perfusion in the evaluation of tumor response of liver metastases of colorectal carcinoma to treatment with Avastin in combination with Capecitabine and Oxaliplatin.
-Evaluation of the antiangiogenic activity of bevacizumab combined with oxaliplatin and capecitabine in first line treatment using MDCT perfusion studies in liver metastases of colorectal cancer in patients over 70 years.
Main objective:Determine whether the observed changes in perfusion CT studies performed at 2 weeks of starting treatment compared to baseline are significant predictors of free time to disease progression in patients in the trial and defined as the time since the start of treatment until objective progressive disease by RECIST criteria.
-Characterization of resistance to bevacizumab in colon cancer in elderly patients.
Main objective: To evaluate the involvement of serum markers and markers in the primary tumor in the resistance to bevacizumab.
研究の種類
入学 (予想される)
段階
- フェーズ2
連絡先と場所
研究場所
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Barcelona、スペイン、08036
- Hospital Clinic I Provincial
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Burgos、スペイン、09005
- Hospital General Yague
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Lérida、スペイン、25198
- Hospital Arnau de Vilanova
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Madrid、スペイン、28046
- Hospital Universitario La Paz
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Madrid、スペイン、28223
- Hospital Quiron de Madrid
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Murcia、スペイン、30008
- Hospital Morales Meseguer
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Valencia、スペイン、46009
- Hospital La Fe de Valencia
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Valencia、スペイン、46014
- Hospital General de Valencia
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Valencia、スペイン、46017
- Hospital Doctor Peset
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Vigo、スペイン、36204
- Hospital Xeral Cies de Vigo
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Barcelona
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Hospitalet de Llobregat、Barcelona、スペイン、08906
- Hospital de L´Hospitalet
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Las Palmas
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Las Palmas de Gran Canaria、Las Palmas、スペイン、35010
- Hospital de Gran Canaria Doctor Negrín
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Madrid
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San Sebastián de los Reyes、Madrid、スペイン、28702
- Hospital Infanta Sofía
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Navarra
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Pamplona、Navarra、スペイン、31008
- Hospital de Navarra
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Valencia
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Játiva、Valencia、スペイン、46800
- Hospital Lluis Alcanyis
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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
Inclusion Criteria:
- Written informed consent.
- ECOG 0-1.
- Age ≥ 70 years.
- Histologically confirmed carcinoma of the colon and/or rectum.
- Metastatic disease non suitable for radical surgery.
- At least one measurable metastatic lesion (as per RECIST criteria). The index lesion must not be in a previously irradiated area.
- Non prior chemotherapy for metastatic disease. Adjuvant (or neo-adjuvant for rectal cancer patients) chemotherapy allowed if completed ≥ 12 months before inclusion.
- Life expectancy more than 3 months.
- Adequate renal function: creatinine ≤ 1.5 x UL and calculated creatinine clearance ≥ 30 mL/min.
- Adequate level function: AST and ALT ≤ 2.5 x UL (≤ 5 x UL if liver metastases), bilirubin ≤ 1.5 x UL.
- Adequate haematological function: Hb ≥ 9 gr/dl, neutrophils ≥ 1,5 x 109 /l and platelets ≥ 100000 x 109/l.
- Urine dipstick for proteinuria < 2+. If urine dipstick is ≥ 2+, 24 hour urine must demonstrate ≤ 1 g of protein in 24 hours.
- No clinical evidence or history of metastatic CNS disease.
- No prior Bevacizumab treatment.
Exclusion Criteria:
- Patients who previously received bevacizumab.
- Prior chemotherapeutic treatment for metastatic CRC.
- Prior treatment with monoclonal antibodies.
- Clinical evidence of brain metastases or history or evidence upon physical examination of CNS disease unless adequately treated.
- Past or current history (within the last 5 years prior to treatment start) of other malignancies except metastatic colorectal cancer (Patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible).
- Clinically significant cardiovascular disease, for example CVA (≤ 6 months before treatment start), myocardial infarction (≤ 6 months before treatment start), unstable angina, NYHA ≥ grade 2, CHF, arrhythmia requiring medication, or uncontrolled hypertension.
- Intestinal occlusion/subocclusion.
- Chronic diarrhea.
- Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to entering this study.
- Known hypersensitivity to any of the study drugs.
- Current or recent (within 10 days of first dose of study treatment) daily use of aspirin (> 325 mg/day) or other NSAID.
- Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic (as opposed to prophylactic) purposes. Patients receiving (or considered candidate to receive) anticoagulants agents as prophylaxis of cardiovascular risk, should continue (or start) the appropriate treatment at study entry.
- History of venous thromboembolic or haemorrhagic events within 6 months prior to treatment.
- Patients with previous of arterial thromboembolic event.
- Evidence of bleeding diathesis or coagulopathy.
- Serious, non healing wound, ulcer, or bone fracture.
- Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to treatment, or anticipation of the need for major surgery during the course of the study.
- Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications.
- Patients of childbearing potential not willing to use effective means of contraception.
- Positive HIV serology.
- Known addiction to alcohol or other drugs.
- Patients included in other clinical trial
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 |
|---|---|
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実験的：bevacizumab, capecitabine, oxaliplatin
6 cycles (3 weeks each one) of:
After the first 6 cycles of treatment, continuing only with bevacizumab and capecitabine |
6 cycles (3 weeks each one) of:
After the first 6 cycles of treatment, continuing only with bevacizumab and capecitabine
他の名前：
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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 |
時間枠 |
|---|---|
|
進行までの時間
時間枠：3年
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3年
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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全生存
時間枠：3年
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3年
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全体の回答率
時間枠：3年
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3年
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Objective response rate following Response Evaluation Criteria In Solid Tumors (RECIST) criteria
時間枠：3 years
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3 years
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Number of treatment cycles administered
時間枠：3 years
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3 years
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Number of patients who have required dose reductions of either drug
時間枠：3 years
|
3 years
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Safety of treatment according to the number of adverse events reported
時間枠：3 yeras
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3 yeras
|
協力者と研究者
捜査官
- スタディチェア：Jaime Feliu Batlle, MD、Grupo Español Multidisciplinario de Cáncer Digestivo
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 (予想される)
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
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