このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

A Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer

2016年3月3日 更新者：Hoffmann-La Roche

An Open-Label Randomized Phase III Study of Intermittent Oral Capecitabine in Combination With Intravenous Oxaliplatin (Q3W) ("XELOX") Versus Bolus and Continuous Infusion Fluorouracil/ Intravenous Leucovorin With Intravenous Oxaliplatin (Q2W) ("FOLFOX4") as Treatment for Patients With Metastatic Colorectal Cancer Who Have Received Prior Treatment With CPT-11 in Combination With 5-FU/LV as First Line Therapy

This 2 arm study will assess the efficacy and safety of intermittent oral Xeloda, or iv fluorouracil/leucovorin, in combination with intravenous Eloxatin (oxaliplatin) in patients previously treated for metastatic colorectal cancer. Patients will be randomized to receive either 1)XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2) FOLFOX-4 (oxaliplatin + leucovorin + 5-FU in 2 week cycles. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

627

段階

  • フェーズ 3

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。

研究場所

  • アメリカ
    • California
      • Bakersfield、California、アメリカ、93309
    • Colorado
      • Colorado Springs、Colorado、アメリカ、80903
    • District of Columbia
      • Washington、District of Columbia、アメリカ、20007-2197
    • Indiana
      • Terre Haute、Indiana、アメリカ、47802
    • Missouri
      • St Louis、Missouri、アメリカ、63136
    • Montana
      • Billings、Montana、アメリカ、59101
    • New York
      • Nyack、New York、アメリカ、10960
    • Texas
      • Dallas、Texas、アメリカ、75204
  • イギリス
      • Denbigh、イギリス、LL18 5UJ
      • Manchester、イギリス、M20 4BX
      • Merseyside、イギリス、CH63 45Y
      • Preston、イギリス、PR2 9HT
  • イスラエル
      • Beer Sheva、イスラエル、8410101
      • Jerusalem、イスラエル、91031
      • Kfar Saba、イスラエル、44281
      • Petach Tikva、イスラエル、49100
      • Ramat-gan、イスラエル、52621
      • Rehovot、イスラエル、76100
      • Tel Aviv、イスラエル、6423906
  • イタリア
      • Bergamo、イタリア、24128
      • Cattolica、イタリア、47841
      • Rimini、イタリア、47900
      • Udine、イタリア、33100
  • カナダ
    • Alberta
      • Edmonton、Alberta、カナダ、T6G 1Z2
    • Newfoundland and Labrador
      • St. John's、Newfoundland and Labrador、カナダ、A1B 3V6
    • Nova Scotia
      • Halifax、Nova Scotia、カナダ、B3H 1V7
    • Ontario
      • London、Ontario、カナダ、N6A 4L6
      • Oshawa、Ontario、カナダ、L1G 2B9
      • Ottawa、Ontario、カナダ、K1H 1C4
      • Saint Catherines、Ontario、カナダ、L2R 2Z7
      • Thunder Bay、Ontario、カナダ、P7A 7T1
      • Toronto、Ontario、カナダ、M5G 2M9
      • Weston、Ontario、カナダ、M9N 1N8
    • Quebec
      • Laval、Quebec、カナダ、H7M 3L9
      • Levis、Quebec、カナダ、G6V 3Z1
      • Montreal、Quebec、カナダ、H1T 2M4
      • Montreal、Quebec、カナダ、H2W 1S6
      • Montreal、Quebec、カナダ、H4J 1C5
      • Quebec City、Quebec、カナダ、G1R 2J6
    • Saskatchewan
      • Regina、Saskatchewan、カナダ、S4T 7T1
  • ギリシャ
      • Heraklion、ギリシャ、71110
      • Thessaloniki、ギリシャ、56439
  • クロアチア
      • Split、クロアチア、21000
      • Zagreb、クロアチア、10000
  • スペイン
      • Barcelona、スペイン、08907
      • Leganes、スペイン、28911
      • Madrid、スペイン、28041
      • Madrid、スペイン、28035
      • Palma de Mallorca、スペイン、07014
  • スロバキア
      • Bratislava、スロバキア、831 01
  • スロベニア
      • Ljubljana、スロベニア、1000
  • セルビア
      • Belgrade、セルビア、11000
  • ドイツ
      • Tübingen、ドイツ、72076
  • フィンランド
      • Tampere、フィンランド、36280
      • Turku、フィンランド、20520
  • フランス
      • Avignon、フランス、84082
      • Bordeaux、フランス、33076
      • Bordeaux、フランス、33075
      • Chambray-lès-tours、フランス、37044
      • Limoges、フランス、87042
      • Nimes、フランス、30029
      • Pessac、フランス、33604
      • Rouen、フランス、76031
  • プエルトリコ
      • San Juan、プエルトリコ、00921-3201
  • ベルギー
      • Bruxelles、ベルギー、1070
      • Bruxelles、ベルギー、1000
      • Gent、ベルギー、9000
      • Kortrijk、ベルギー、8500
      • Mont-godinne、ベルギー、5530
  • ポーランド
      • Bialystok、ポーランド、15-073
      • Krakow、ポーランド、31-501
      • Warszawa、ポーランド、02-781
      • Warszawa、ポーランド、04-394
  • 南アフリカ
      • Cape Town、南アフリカ、7500
      • Durban、南アフリカ、4001
      • Pietermaritzburg、南アフリカ、3201
      • Port Elizabeth、南アフリカ、6001
      • Pretoria、南アフリカ、0001
  • 台湾
      • Kueishan、台湾
      • Tainan、台湾、704
      • Taipei、台湾、104
  • 大韓民国
      • Buchun、大韓民国、420-021
      • Seoul、大韓民国、138-736
      • Seoul、大韓民国、110-744
      • Seoul、大韓民国、120-752
      • Seoul、大韓民国、133-792
      • Seoul、大韓民国、137-040

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:

  • adult patients >=18 years of age;
  • metastatic colorectal cancer;
  • >=1 target lesion;
  • failed first-line chemotherapy with 5-fluorouracil and irinotecan.

Exclusion Criteria:

  • previous treatment with oxaliplatin;
  • progressive or recurrent disease during or within 6 months of completion of first-line chemotherapy;
  • >=1 previous chemotherapeutic agent or systemic anticancer regimen for metastatic disease.

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：ランダム化
  • 介入モデル：並列代入
  • 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：XELOX
Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
薬：カペシタビン［ゼローダ］
各 3 週間サイクルの 1 ～ 15 日目に 1000mg/m2 経口入札
薬：Oxaliplatin
As prescribed, in 3 week cycles
薬：Oxaliplatin
As prescribed, in 2 week cycles
アクティブコンパレータ：FOLFOX-4
Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m^2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
薬：Oxaliplatin
As prescribed, in 3 week cycles
薬：Oxaliplatin
As prescribed, in 2 week cycles
薬：5 FU
As prescribed, in 2 week cycles
薬：Leucovorin
As prescribed, in 2 week cycles

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
時間枠：Up to 3 years
Progression free survival (PFS) is defined as the time from the date of randomization to the day of documented disease progression or death from any cause. It was based on tumor assessments made according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0, wherein progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameter (LD) of the target lesions (TLs), taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions or unequivocal progression of existing non-target lesions. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed. Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cut-off were censored at date of randomization
Up to 3 years

二次結果の測定

結果測定
メジャーの説明
時間枠
Progression Free Survival Based on Independent Review Committee Assessment
時間枠：Up to 3 years
Progression free survival (PFS) is defined as the time from the date of randomization to the day of documented disease progression or death from any cause. It was based on tumor assessments made according to the RECIST version 1.0, wherein PD was defined as at least a 20% increase in the sum of the LD of the TLs, taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions or unequivocal progression of existing non-TLs. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed. Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cut-off were censored at date of randomization. This PFS evaluation was based on Independent Review Committee Assessment.
Up to 3 years
Progression Free Survival Based on Treatment Analysis- Intent To Treat Population
時間枠：Up to 3 years
Progression free survival (PFS) is defined as the time from date of randomization to day of documented disease progression or death from any cause. It was based on tumor assessments made according to the RECIST version 1.0, wherein PD was defined as at least a 20% increase in the sum of LD of the TLs, taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions or unequivocal progression of existing non-TLs. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed. Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cut-off were censored at date of randomization. PFS was analyzed using an on-treatment approach included only disease progression and death that occurred no later than 28 days after the last confirmed intake of study medication in the primary study treatment phase.
Up to 3 years
Progression Free Survival Based on Treatment Analysis- Per Population
時間枠：Up to 3 years
Progression free survival (PFS) is defined as the time from the date of randomization to the day of documented disease progression or death from any cause. It was based on tumor assessments made according to the RECIST version 1.0, wherein PD was defined as at least a 20% increase in the sum of the LD of the TLs, taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions or unequivocal progression of existing non-TLs. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed. Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cut-off were censored at date of randomization
Up to 3 years
Best Overall Response, Investigators' Assessments
時間枠：Up to 3 years
Best overall response is best response recorded from start of treatment until disease progression/recurrence where responses include complete response (CR), partial response (PR), or stable disease (SD). CR was defined as disappearance of all TLs, non-TLs along with normalization of tumor marker level. PR is at least 30% decrease in sum of the LD of TLs, taking as reference baseline sum LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking reference of smallest sum LD since treatment started. It was dependent on achievement of measurement and confirmation criteria. BOR .i.e. CR or PR was confirmed by repeat assessments performed within 4 weeks. For SD, follow-up assessments had to meet the SD criteria at least once after study entry within 6 to 8 weeks.
Up to 3 years
Best Overall Response, Independent Review Committee Assessment
時間枠：Up to 3 years
Best overall response is best response recorded from start of treatment until disease progression/recurrence where responses include CR, PR, or SD. CR was defined as disappearance of all TLs, non-TLs along with normalization of tumor marker level. PR is at least 30% decrease in sum of the LD of TLs, taking as reference baseline sum LD. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking reference of smallest sum LD since treatment started. It was dependent on achievement of measurement and confirmation criteria. BOR .i.e. CR or PR was confirmed by repeat assessments performed within 4 weeks, for SD, follow-up assessments had to meet the SD criteria at least once after study entry within 6 to 8 weeks. This PFS evaluation was based on Independent Review Committee Assessment.
Up to 3 years
Overall Survival
時間枠：Up to 3 years
Overall survival was measured as the time from the date of randomization to the date of death. Participant who were not reported to have died at the time of the analysis were censored using the date they were last known to be alive.
Up to 3 years
Time To Response
時間枠：Up to 3 years
Time to response (TOR) (best response of CR or PR) was measured as the time from randomization to the first date on which the measurement criteria for CR or PR (whichever status was recorded first) were met. CR for TLs was defined as disappearance of all TLs and for non-TLs as disappearance of all non-TLs and normalization of tumor marker level. PR was defined as at least 30% decrease in the sum of the LD of TLs, taking as reference the baseline sum LD.
Up to 3 years
Duration Of Response
時間枠：Up to 3 years
Duration of response (DOR) is defined as the time when CR or PR was first met up to first date that PD or death is documented. CR is defined as disappearance of all TLs and non TLs, PR is defined as at least 30% decrease in the sum of the LD of TLs, taking as reference the baseline sum LD. PD was defined as at least a 20% increase in the sum of the LD of the TLs, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions for the TLs or the appearance of one or more new lesions and/or unequivocal progression of existing non-TLs.
Up to 3 years
Time To Treatment Failure
時間枠：Up to 3 years
Time to treatment failure was defined as the time from the date of randomization to the first occurrence of adverse event (AE), insufficient therapeutic response, death, failure to return, or refusing treatment/being uncooperative/withdrawing consent.
Up to 3 years
Number of Participants With Marked Post-baseline Laboratory Abnormalities by Trial Treatment
時間枠：Up to 3 years
Laboratory abnormalities were defined as those values that were outside the Roche defined reference range and showed a clinically relevant change from baseline. All laboratory parameters were categorized according to the National Cancer Center Common Toxicity Criteria (NCI-CTCAE) grading system. Incidence of Grade 1 to 4 laboratory abnormalities are presented in the table below.
Up to 3 years

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。

スポンサー

Hoffmann-La Roche

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

2003年7月1日

一次修了 (実際)

2006年8月1日

研究の完了 (実際)

2006年8月1日

試験登録日

最初に提出

2003年9月15日

QC基準を満たした最初の提出物

2003年9月17日

最初の投稿 (見積もり)

2003年9月18日

学習記録の更新

投稿された最後の更新 (見積もり)

2016年4月1日

QC基準を満たした最後の更新が送信されました

2016年3月3日

最終確認日

2016年3月1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

  • NO16967

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。

大腸がんの臨床試験

  • Jonsson Comprehensive Cancer Center
    National Cancer Institute (NCI); Highlight Therapeutics
    積極的、募集していない
    切除可能な軟部肉腫の治療のための手術前のニボルマブと BO-112
    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

カペシタビン［ゼローダ］の臨床試験

類似の治験を検索

スポンサーと協力者

医学的状態

薬物療法

CROs by country

CROs in Cote d'Ivoire

条件

まれな病気

薬物療法

ダイエットサプリメント

スポンサー/協力者

場所

3
購読する