FOLFOXIRI Plus Panitumumab Patients With Metastatic KRAS Wild-Type Colorectal Cancer With Liver Metastases Only
2015年5月7日 更新者：SCRI Development Innovations, LLC
A Phase II Study of FOLFOXIRI Plus Panitumumab Followed by Evaluation for Resection, in Patients With Metastatic KRAS Wild-Type Colorectal Cancer With Liver Metastases Only
In this Phase II study the investigators plan to determine the overall response rate (ORR) of the combination of FOLFOXIRI plus panitumumab as first-line treatment of patients with liver-only metastatic KRAS wild-type colorectal cancer.
調査の概要
詳細な説明
Further data has emerged showing a consistent lack of efficacy using EGFR inhibitor panitumumab in combination with chemotherapy in the treatment of patients with KRAS mutant colorectal cancer.
For patients with liver-only metastatic colorectal cancer, improvement in response rates with newer chemotherapy regimens has led to a larger percentage of patients eligible for surgical resection.
Treatment with FOLFOXIRI improves response rates when compared to FOLFIRI.
Similarly, the addition of an EGFR inhibitor improves the response rate of FOLFIRI in patients with wild-type KRAS.
In this trial, we will attempt to maximize the response rate and the surgical resection rate by using FOLFOXIRI and panitumumab.
研究の種類
介入
入学 (実際)
15
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。
研究場所
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Arkansas
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Jonesboro、Arkansas、アメリカ、72401
- NEA Baptist Clinic
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Florida
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Ft. Myers、Florida、アメリカ、33916
- Florida Cancer Specialists
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Orlando、Florida、アメリカ、32804
- Florida Hospital Cancer Institute
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St. Petersburg、Florida、アメリカ、33705
- Florida Cancer Specialists
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Georgia
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Gainesville、Georgia、アメリカ、30501
- Northeast Georgia Medical Center
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Indiana
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Terre Haute、Indiana、アメリカ、47802
- Providence Medical Group
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Terre Haute、Indiana、アメリカ、47802
- Hope Cancer Center
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Maryland
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Bethesda、Maryland、アメリカ、20817
- Center for Cancer and Blood Disorders
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New Hampshire
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Portsmouth、New Hampshire、アメリカ、03801
- Portsmouth Regional Hospital
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New Jersey
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Morristown、New Jersey、アメリカ、07960
- Hematology-Oncology Associates of Northern NJ
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Ohio
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Cincinnati、Ohio、アメリカ、45242
- Oncology Hematology Care, Inc
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Tennessee
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Chattanooga、Tennessee、アメリカ、37404
- Chattanooga Oncology Hematology Associates
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Collierville、Tennessee、アメリカ、38017
- Family Cancer Center
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Nashville、Tennessee、アメリカ、37203
- Tennessee Oncology, PLLC
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Texas
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Fort Worth、Texas、アメリカ、76104
- The Center for Cancer and Blood Disorders
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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:
- Patient must have a biopsy confirmed adenocarcinoma of the colon or rectum with stage IV (metastatic) liver-only disease, as defined by staging with CT scans.
- Patients must have a baseline evaluation to determine whether liver metastases are resectable (e.g. a single liver metastasis in a resectable location)or unresectable (surgical consultation is recommended). Both groups are eligible for this study.
- Tumor tissue must reveal wild-type KRAS expression (i.e. no KRAS mutation) prior to study entry (see Section 7.4.4.).
- Patients must have at least one unidimensional measurable lesion definable by CT scan. Disease must be measurable per RECIST version 1.1 criteria (see Section 9).
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (see Appendix A).
Laboratory values as follows:
ANC greater than 1500/μL
Hgb greater than9 g/dL
Platelets greater than 100,000/μL
AST/SGOT less than 5.0 x ULN
ALT/SGPT less than or equal to 5.0 x ULN
Alk Phos less than or equal to 5.0 x ULN
Bilirubin less than or equal to 1.5 x ULN
Creatinine 1.5 mg/dL or calculated creatinine clearance 50 ml/min
Magnesium LLN
- Patient must have a life expectancy of greater than 12 weeks.
- Patient must be greater than or equal to 18 years of age.
- Patient must be accessible for treatment and follow-up.
- Women of childbearing potential must have a negative serum or urine pregnancy test performed less than or equal to 7 days prior to start of treatment. Women of childbearing potential or men with partners of childbearing potential must use effective birth control measures during treatment and during the 6 months following completion of study treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.
- Patient must be able to understand the nature of the study and give written informed consent prior to study entry.
Exclusion Criteria:
- Prior systemic therapy for metastatic colorectal cancer (including chemotherapy, bevacizumab, cetuximab, panitumumab, and other targeted agents).
- Adjuvant chemotherapy (and/or chemoradiation) for colorectal carcinoma ending less than or equal to 12 months prior to the diagnosis of metastatic cancer. Prior radiation therapy (in the metastatic setting) may be allowed if it was completed greater than or equal to 4 weeks prior to enrollment and measurable lesions are outside the radiation portal site.
- Any detectable metastases in areas other than the liver.
- Known liver disease or other significant medical illness that would exclude the patient as a candidate for resection of liver metastases.
- Patients requiring therapeutic coumadin or heparin (for a history of pulmonary emboli or deep vein thrombosis [DVT]) will be excluded.
- Patients who have had a major surgical procedure (not including mediastinoscopy), open biopsy, or significant traumatic injury less than or equal to 4 weeks prior to beginning treatment.
- History of Gilbert's disease.
- History of hypersensitivity to active or inactive excipients of any component of treatment (5 fluorouracil, irinotecan, panitumumab, and/or oxaliplatin), or known dipyrimidine dehydrogenase (DPD) deficiency
- Serious cardiac arrhythmia requiring medication.
- Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, an infection requiring IV antibiotics, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patient with known diagnosis of human immunodeficiency virus (HIV), hepatitis C virus or acute or chronic hepatitis B infection.
- Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.
- Use of any non-approved or investigational agent less than or equal to 28 days prior to administration of the first dose of study drug.
- Past or current history of neoplasm other than the entry diagnosis with the exception of treated non melanoma skin cancer or carcinoma in situ of the cervix, or other cancers cured by local therapy alone and a DFS greater than or equal to 5 years.
- Patients with National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (NCI CTCAE) Grade 2 peripheral neuropathy.
- Female patients who are pregnant or lactating.
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：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：FOLFOXIRI+panitumumab regimen
All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:
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6 mg/kg, 60-90 minute IV infusion every 2 weeks
他の名前：
85 mg/m2, 2-hour IV infusion every 2 weeks
他の名前：
125 mg/m2, 1-hour IV infusion every 2 weeks
他の名前：
200 mg/m2, 2-hour IV infusion every 2 weeks
他の名前：
3200 mg/m2 IV, 48-hour continuous infusion every two weeks
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Overall Response Rate (ORR)
時間枠：18 months
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The Percentage of Patients Who Experience an Objective Benefit From Treatment.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
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18 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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全体的な生存 (OS)
時間枠：18ヶ月
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プロトコール治療の最初の日から死亡するまで患者が生存していた期間（月単位）
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18ヶ月
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Progression-free Survival (PFS)
時間枠：18 months
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The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
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18 months
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R0 Resection Rate
時間枠：18 months
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To determine the rate of complete (R0) resection for patients treated with this regimen.
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18 months
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To Determine the Acute Toxicity Produced by This Regimen.
時間枠：18 months
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The analyses of safety will be based on the frequency of adverse events and their severity for patients who received at least one dose of study treatment.
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18 months
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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
- スタディチェア：Johanna Bendell, MD、SCRI Development Innovations, LLC
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
2010年12月1日
一次修了 (実際)
2014年3月1日
研究の完了 (実際)
2014年3月1日
試験登録日
最初に提出
2010年10月15日
QC基準を満たした最初の提出物
2010年10月20日
最初の投稿 (見積もり)
2010年10月22日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年5月27日
QC基準を満たした最後の更新が送信されました
2015年5月7日
最終確認日
2015年5月1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
- SCRI GI 134
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