1行目の設定での毎月の交互ナリリフォックスとGNP
転移性膵管腺癌の第一選択環境での毎月の交互ナリリフォックスとGNP
A prospective, interventional, single-center, single-arm, open-label, phase II study for patients with metastatic pancreatic cancer. The intervention consists of monthly alternating standard chemotherapy regimens-NALIRIFOX and GnP. The hypothesis is that induction therapy with alternating NALIRIFOX and GnP has better efficacy compared to historical observation.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：GI Trial Referral
- 電話番号：5167348896
- メール：gitrialreferral@northwell.edu
研究連絡先のバックアップ
- 名前：Lalta Dhanantwari, MBA
- 電話番号：5167348896
- メール：ldhanantwari@northwell.edu
研究場所
-
-
New York
-
Bay Shore、New York、アメリカ、11706
- 募集
- Imbert Cancer Center
-
コンタクト：
- GI Trial Referral
- 電話番号：516-734-8896
- メール：gitrialreferral@northwell.edu
-
Mount Kisco、New York、アメリカ、10549
- 募集
- Northern Westchester Cancer Center
-
コンタクト：
- GI Trial Referral
- 電話番号：516-734-8896
- メール：gitrialreferral@northwell.edu
-
New Hyde Park、New York、アメリカ、11040
- 募集
- Long Island Jewish Medical Center
-
コンタクト：
- GI Trial Referral
- 電話番号：516-734-8896
- メール：gitrialreferral@northwell.edu
-
New Hyde Park、New York、アメリカ、11042
- 募集
- Zuckerberg Cancer Center
-
コンタクト：
- Daniel King, MD
- 電話番号：5167348900
- メール：dking14@northwell.edu
-
主任研究者：
- Daniel King, MD, PhD
-
コンタクト：
- GI Trial Referral
- 電話番号：516-734-8896
- メール：gitrialreferral@northwell.edu
-
New York、New York、アメリカ、10065
- 募集
- Manhattan Eye, Ear and Throat Hospital
-
コンタクト：
- GI Trial Referral
- 電話番号：516-734-8896
- メール：gitrialreferral@northwell.edu
-
Rego Park、New York、アメリカ、11374
- 募集
- NHPP Medical Oncology at Rego Park
-
コンタクト：
- GI Trial Referral
- 電話番号：516-734-8896
- メール：gitrialreferral@northwell.edu
-
Sleepy Hollow、New York、アメリカ、10591
- 募集
- Phelps Cancer Center
-
コンタクト：
- GI Trial Referral
- 電話番号：516-734-8896
- メール：gitrialreferral@northwell.edu
-
-
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:
-
>18 years of age
-
Histologically proven pancreatic ductal adenocarcinoma, poorly differentiated carcinoma, or adenosquamous carcinoma
-
Radiographic evidence of metastatic disease
-
At least 1 measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
-
Metastatic relapse of previously resected pancreatic cancer is allowed provided the patient is more than 6 months from last SOC adjuvant treatment
-
ECOG PS 0-1
-
Laboratory assessments within 14 days as indicated below:
- Hemoglobin > 9.0 g/dL (patients with hemoglobin < 9 g/dL may be transfused prior to study enrollment)
- Platelet count > 100 x 10^9/L
- Absolute neutrophil count (ANC) > 1.5 x 10^9/L
- Total bilirubin < 3 x upper limit of normal (ULN)
- Aspartate transaminase (AST) and alanine transaminase (ALT) < 3 x ULN (if liver metastases are present, AST and ALT < 5 x ULN is permitted.
- Creatinine ≤1.5 ULN
- Creatinine clearance > 40 mL/min as calculated by Cockcroft-Gault formula
- APTT (aPTT) ≤ 1.5 × ULN. For subjects receiving unfractionated heparin < 2.5 × ULN, or within acceptable range considered by the investigator.
- PT/INR INR ≤ 1.5 × ULN. For subjects receiving warfarin, 2.0 -3.0, or within acceptable range considered by the investigator.
-
Women of childbearing potential must be surgically sterile or postmenopausal or must have a negative pregnancy test (serum or urine) prior to study enrolment and must use effective barrier contraception or abstinence during the treatment period. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions and therefore are not considered effective for this study. Male patients must be surgically sterile or use effective contraception or abstinence during the treatment period. The definition of effective contraception will be based on investigator discretion. Female and male patients are advised to use effective contraceptives for at least 9 months after the last treatment dose.
-
Ability to understand and willing to sign informed consent form
Exclusion:
- A history of other disease, metabolic dysfunction, physical examination finding or clinical laboratory test result suspicious of a disease or condition which, in the opinion of the investigator, would compromise patient safety due to risk of treatment complications or could affect interpretation of the study results
- Ampullary, acinar, squamous, and neuroendocrine histology
- Presence of central nervous system metastases
- Life expectancy < 12 weeks
- Pregnant or breastfeeding women
- Prior neuropathy > grade 1 as per CTCAE v5
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
- Major surgery within 4 weeks prior to initiation of the study treatment, without full recovery
- Any past chemotherapy delivered for metastatic pancreatic cancer
- Known somatic or germline mutations in BRCA1, BRCA2, or PALB2
- Active second malignancy whose prognosis has a high likelihood of impacting survival
- Any other medical or social condition deemed by the investigator to be likely to interfere with a subject's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results. Patients also unwilling or unable to comply with study procedures and/or study visits, including long-term follow-up for survival.
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：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 |
|---|---|
|
アクティブコンパレータ：NALIRIFOX
NALIRIFOX consists of 5-FU 2400 mg/m2 over 46 hours, liposomal irinotecan 50 mg/m2, and oxaliplatin 60 mg/m2, which would be given on Day 1 and Day 15 |
NALIRIFOX consists of 5-FU 2400 mg/m2 over 46 hours, liposomal irinotecan 50 mg/m2, and oxaliplatin 60 mg/m2, which would be given on Day 1 and Day 15
他の名前：
|
|
アクティブコンパレータ：Gemcitabine plus nab-Paclitaxel (GnP)
GnP consists of gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m2, given on Days 1, 8, and 15. |
GnP consists of gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m2, given on Days 1, 8, and 15.
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 |
|---|---|---|
|
Determine 6-month Progression Free Survival (PFS)
時間枠：6 months
|
The primary endpoint is 6-month PFS rate defined as the proportion of patients alive and progression free (by RECIST v.1.1) at 6 months after treatment initiation. PFS events will be classified as either local progression, distant recurrence, secondary malignancy, or death. |
6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall Response Rate
時間枠：24 months
|
Overall response rate, defined as the proportion of patients whose best response is partial response or complete response by RECIST v.1.1 |
24 months
|
|
Disease Control Rate
時間枠：24 months
|
Disease control rate, defined as the proportion of patients whose best response is stable disease, partial response, or complete response, by RECIST v.1.1 |
24 months
|
|
Overall Survival
時間枠：24 months
|
OS, defined as the time from treatment initiation to death. Patients living without disease progression will be censored at the date of last assessment |
24 months
|
|
Determine Toxicities using the NCI CTCAE v. 5.0
時間枠：24 months
|
AEs will be monitored, and the incidence, severity, and relationship to study drug will be reported. |
24 months
|
|
Time to Treatment Failure
時間枠：24 months
|
Time to treatment failure, defined as the time from treatment initiation to discontinuation of treatment, either due to progression or intolerance |
24 months
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
- 24-0950
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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。