Study of Capecitabine With Irinotecan and Oxaliplatin (Eloxatin) in Advanced Colorectal Cancer
2013年11月21日 更新者：H. Lee Moffitt Cancer Center and Research Institute
A Phase II Study of Capecitabine in Combination With Irinotecan and Oxaliplatin (Eloxatin) in Adult Patients With Advanced Colorectal Cancer
The purpose of this study is to find out how effective the new combination of the drugs Capecitabine (Xeloda), Oxaliplatin (Eloxatin), and Irinotecan (Camptosar) are against colon and rectal cancer.
All three of these drugs are approved by the Food and Drug Administration (FDA) for the treatment of colon or rectal cancer.
This however is the first time that these three drugs have been combined in this schedule for the treatment of colon/rectal cancer.
調査の概要
詳細な説明
The primary objective of the study is to determine the radiographic response rate in patients with metastatic colorectal cancer treated with Oxaliplatin, Capecitabine and Irinotecan.
Secondary objectives are to determine the time to tumor progression and the toxicity and tolerability of Oxaliplatin, Capecitabine and Irinotecan when administered in combination.
Study schema is as follows.
Cycles are 42 days long.
Patients will receive Oxaliplatin and Capecitabine on day 1.
Capecitabine is an oral pill that will be taken for 14 days.
Patients return again on day 21 when they receive Irinotecan and Capecitabine.
Capecitabine again is taken for 14 days.
CT scans are performed at the end of the 6 week cycle to determine response.
研究の種類
介入
入学 (実際)
24
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Patients must have histological or cytological confirmed metastatic colorectal cancer.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan.
- No prior chemotherapy in the metastatic setting (prior fluorouracil chemotherapy, if administered in the adjuvant setting, and if more than 6 months has passed since the completion of therapy, is allowable). Prior adjuvant radiation therapy allowable provided no greater than 30% total bone marrow included in the field (must be more than 6 weeks since completion of radiation therapy.
- Subject must be 18 years or older
- Life expectancy greater than 12 weeks.
- ECOG performance status <2 (Karnofsky >60%).
- Patients must have normal organ and marrow function as defined as: leukocytes >3,000/mcL; absolute neutrophil count >1,500/mcL; Platelets >100,000/mcL; total bilirubin within normal institutional limits; AST(SGOT)/ALT (SGPT) <2.5 X institutional upper limit of normal; Creatinine within normal institutional limits and Creatinine clearance (estimated by Cockcroft-Gault equation)>50-mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- Has a negative serum or urine pregnancy test within 7 days prior to initiation of therapy (female patients of childbearing potential).
- Woman of childbearing potential with either a positive or no pregnancy test at baseline. (Postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential). Patients will agree to continue contraception for 30 days from the date of the last study drug administration
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- Prior therapy for MCRC in the metastatic setting.
- Patients may not be receiving any other investigational agents.
- Patients with known brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- Grade 2 or greater peripheral neuropathy.
- Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months.
- Pregnant and nursing women are excluded from this study. Women / men of childbearing potential not using a reliable and appropriate contraceptive method.
- Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with Oxaliplatin and Irinotecan or other agents administered during the study.
- Major surgery within 4 weeks of the start of study treatment, without complete recovery.
- Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
- History of clinically significant interstitial lung disease and/or pulmonary fibrosis.
- History of persistent neurosensory disorder including but not limited to peripheral neuropathy
- Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer.
- Participation in any investigational drug study within 4 weeks preceding the start of study treatment.
- Any prior platinum based therapy
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：非ランダム化
- 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：Combination Therapy
Capecitabine in Combination with Irinotecan and Oxaliplatin
|
Capecitabine will be administered at a dose of 825 mg/m2 PO BID, for a total daily dose of 1650 mg/m2.
Capecitabine will be administered on days 1-14 followed by 7 day treatment free rest period and days 21-35 followed by a 7 day treatment-free rest period, every six weeks (42 days) of treatment is considered one cycle.
他の名前：
Oxaliplatin will be administered at a dose of 130 mg/m2 IV over 120 minutes in 250-500 ML D5W on day 1, every 42 days.
他の名前：
Irinotecan will be administered at a dose of 180mg/m2 IV over 90 minutes on day 21 every 42 days.
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 |
|---|---|---|
|
response rate
時間枠：average of 12 months
|
To determine the radiographic response rate in patients with metastatic colorectal cancer treated with Oxaliplatin, Capecitabine and Irinotecan
|
average of 12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
time to tumor progression
時間枠：average of 12 months
|
To determine the time to tumor progression in patients with metastatic colorectal cancer treated with Oxaliplatin, Capecitabine and Irinotecan
|
average of 12 months
|
|
toxicity and tolerability
時間枠：average of 12 months
|
To determine the toxicity and tolerability of Oxaliplatin, Capecitabine and Irinotecan when administered in combination
|
average of 12 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
協力者
捜査官
- 主任研究者：Christopher Garrett, MD、H. Lee Moffitt Cancer Center & Research Institute (now at M.D. Anderson)
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2004年12月1日
一次修了 (実際)
2007年7月1日
研究の完了 (実際)
2007年7月1日
試験登録日
最初に提出
2005年9月19日
QC基準を満たした最初の提出物
2005年9月19日
最初の投稿 (見積もり)
2005年9月22日
学習記録の更新
投稿された最後の更新 (見積もり)
2013年11月25日
QC基準を満たした最後の更新が送信されました
2013年11月21日
最終確認日
2010年9月1日
詳しくは
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。