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Second-Line Adjuvant Therapy With Nab-Paclitaxel Plus Gemcitabine Versus Oxaliplatin Plus Folinic Acid and Fluorouracil for Gemcitabine-Refractory Pancreatic Cancer After Curative Resection

10 августа 2016 г. обновлено: Xian-Jun Yu, Fudan University

A Prospective, Multi-centric, Phase Ⅲ, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Second-Line Adjuvant Therapy With Nab-Paclitaxel Plus Gemcitabine (AG) Versus Oxaliplatin Plus Folinic Acid and Fluorouracil (OFF) for Gemcitabine-Refractory Pancreatic Cancer After Curative Resection

The purpose of this study is to investigate the activity and safety of second-line adjuvant therapy with nab-paclitaxel plus gemcitabine (AG) versus oxaliplatin plus folinic acid and fluorouracil (OFF) for gemcitabine-refractory pancreatic cancer after curative resection.

Обзор исследования

Статус

Неизвестный

Условия

Вмешательство/лечение

Подробное описание

PRIMARY OBJECTIVES:

  • To evaluate the therapeutic efficacy of second-line adjuvant therapy with nab-paclitaxel plus gemcitabine (AG) versus oxaliplatin plus folinic acid and fluorouracil (OFF) in terms of overall survival for gemcitabine-refractory pancreatic cancer after curative resection.

SECONDARY OBJECTIVES:

  • To evaluate the therapeutic efficacy of two regimens in terms of objective response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • To evaluate the time to remission of patients treated with the two regimens.
  • To evaluate the progression-free survival of patients treated with the two regimens.
  • To evaluate the levels of tumor biomarkers in serum of patients treated with the two regimens, including Carbohydrate Antigen (CA)19-9、CA125、CA153、CA242、CA72-4、CA50、CEA、AFP.
  • To evaluate the occurrence of grade 3 and 4 toxicities according to National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI CTCAE) version 4.0 in patients treated with the two regimens.
  • To evaluate the quality of life score of patients treated with the two regimens.

Detailed Description of Arms:

Patients are randomized to 1 of 2 treatment arms (Arm AG or Arm OFF). Arm AG: Firstly, patients receive nab-paclitaxel 100 mg/m^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Secondly, patients receive gemcitabine 1000 mg/m^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats until there is disease progression or recurrence.

Arm OFF: Patients receive oxaliplatin 85 mg/m^2 (iv, 2 hours) on days 8 and 22 with 42 days as a cycle. Patients receive folinic acid 200 mg/m^2 (iv) and fluorouracil 2000 mg/m^2 (iv, 24 hours) on days 1, 8, 15 and 22 for 4 weeks, followed by 2 weeks without treatment. Oxaliplatin is given before folinic acid and fluorouracil when the three drugs are given on the same days. Treatment repeats until there is disease progression or recurrence.

Тип исследования

Интервенционный

Регистрация (Ожидаемый)

300

Фаза

  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Xian-Jun Yu, M.D PH.D
  • Номер телефона: +86 21 64175590
  • Электронная почта: yuxianjun@fudanpci.org

Учебное резервное копирование контактов

  • Имя: Wen-Quan Wang, M.D PH.D
  • Номер телефона: +86 21 64175590
  • Электронная почта: wangwenquan@fudanpci.org

Места учебы

  • Китай
    • Guangdong
      • Guangzhou, Guangdong, Китай, 510060
        • Рекрутинг
        • Department of Hepatobiliary Surgery, Sun Yat-Sen University Cancer Center,Sun Yat-Sen University
        • Контакт:
          • Sheng-Ping Li, M.D PH.D
          • Номер телефона: 020-87343088
          • Электронная почта: lishengp@mail.sysu.edu.cn
        • Главный следователь:
          • Sheng-Ping Li, M.D PH.D
    • Shanghai
      • Shanghai, Shanghai, Китай, 200032
        • Рекрутинг
        • Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
      • Shanghai, Shanghai, Китай, 200003
        • Рекрутинг
        • Department of Biliary Pancreatic Surgery, Shanghai Changzheng Hospital, The Second Military Medical University
        • Контакт:
          • Cheng-Hao Shao, M.D PH.D
          • Номер телефона: 021-81886999
          • Электронная почта: schhao88@gmail.com
        • Главный следователь:
          • Cheng-Hao Shao, M.D PH.D
      • Shanghai, Shanghai, Китай, 200040
        • Рекрутинг
        • Department of Biliary Pancreatic Surgery, Huadong Hospital, Fudan University
        • Контакт:
          • Wei Wang, M.D PH.D
          • Номер телефона: 021-62483180
          • Электронная почта: wangw2003cn@hotmail.com
        • Главный следователь:
          • Wei Wang, M.D PH.D
      • Shanghai, Shanghai, Китай, 200040
        • Рекрутинг
        • Department of Pancreatic Surgery, Huashan Hospital, Fudan University
        • Контакт:
          • De-Liang Fu, M.D PH.D
          • Номер телефона: 021-52889999
          • Электронная почта: surgeonfu@163.com
        • Главный следователь:
          • De-Liang Fu, M.D PH.D
    • Tianjin
      • Tianjin, Tianjin, Китай, 300060
        • Рекрутинг
        • Department of Pancreatic Surgery, Cancer Institute & Hospital, Tianjin Medical University
        • Контакт:
          • Ji-Hui Hao, M.D PH.D
          • Номер телефона: 022-23340123
          • Электронная почта: haojihui@tjmuch.com
        • Главный следователь:
          • Ji-Hui Hao, M.D PH.D
    • Zhejiang
      • Hangzhou, Zhejiang, Китай, 310016
        • Рекрутинг
        • Department of General Surgery,Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
        • Контакт:
          • Yi-Ping Mou, M.D PH.D
          • Номер телефона: 0571-86090073
          • Электронная почта: mouyp@srrsh.com
        • Главный следователь:
          • Yi-Ping Mou, M.D PH.D

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 18 лет до 75 лет (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria:

  • Signed informed content obtained prior to treatment
  • Age ≥ 18 years and ≤ 75 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Patients must have histologically confirmed pancreatic adenocarcinoma (or any mixed pathology if adenocarcinoma is predominant) after R0 or R1 resection. The pathological staging does not exceed the stage ⅡB. And the patients have received gemcitabine as adjuvant chemotherapy after curative resection.
  • There is progression or recurrence of tumor during the course of adjuvant chemotherapy with gemcitabine, or within 6 months after the whole courses of treatment.
  • No severe defects in hematological system, immune system, cardiac function and pulmonary function.
  • White blood cell (WBC) ≥ 4 × 10^9/L; Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; Platelets (PLT) ≥ 100 × 10^9/L; Hemoglobin (Hgb) ≥ 9 g/dL
  • Aspartate aminotransferase (AST) (serum glutamate oxaloacetate transaminase (SGOT)）/ alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase (SGPT)) ≤ 2.5 × institutional upper limit of normal (ULN); Total bilirubin (TBIL) ≤ ULN; Creatinine (CRE) ≤ 1.5 × ULN
  • Prothrombin time (PT) and international normalized ratio (INR) ≤ 1.5 × ULN
  • The patients are willing to comply to the study plan and other requirements.

Exclusion Criteria:

  • There is another malignant tumor with the patient.
  • Patients who have received any form of anti-tumor therapy within 4 weeks prior to the enrollment, including chemotherapy, radiotherapy, interventional chemoembolization, radiofrequency ablation, and molecular targeted therapy
  • Use of any other investigational agents within 4 weeks prior to the enrollment.
  • The progression or recurrence of tumor occurs after 6 months of the course of the adjuvant chemotherapy with gemcitabine.
  • Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, internal hemorrhage, pancreatic leakage, bile leakage, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • History of allergic reactions attributed to compounds of similar chemical or biological composition to the drugs.
  • Metabolic acidosis, acute or chronic, including ketoacidosis
  • Pregnant or nursing women
  • Any event or condition that is possible to harm the safety of the patients or the integrities of data, including severe medical risk factors, medical conditions, and laboratory disorders.
  • Patients who are unwilling or unable to comply with study procedures, or may be absent from the observation for more than 7 days.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: nab-paclitaxel + gemcitabine (AG)
nab-paclitaxel at 100 mg/m^2 on days 1, 8, and 15; gemcitabine at 1000 mg/m^2 on days 1, 8, and 15
Лекарство: nab-paclitaxel
Patients firstly receive nab-paclitaxel 100 mg/m^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats until there is disease progression or recurrence.
Другие имена:
  • Абраксан
Лекарство: gemcitabine
Patients secondly receive gemcitabine 1000 mg/m^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats until there is disease progression or recurrence.
Другие имена:
  • ГЕМЗАР
Экспериментальный: oxaliplatin + folinic acid + fluorouracil (OFF)
oxaliplatin at 85mg/m^2 on days 8 and 22, folinic acid at 200mg/m^2 on days 1,8,15 and 22, fluorouracil at 2000mg/m^2 on days 1,8,15 and 22.
Лекарство: oxaliplatin
Patients receive oxaliplatin 85 mg/m^2 (iv, 2 hours) on days 8 and 22 with 42 days as a cycle. Treatment repeats until there is disease progression or recurrence. Oxaliplatin is given before folinic acid and fluorouracil when the three drugs are given on the same days.
Лекарство: folinic acid
Patients receive folinic acid 200 mg/m^2 (iv) on days 1, 8, 15 and 22 for 4 weeks, followed by 2 weeks without treatment. Treatment repeats until there is disease progression or recurrence.
Другие имена:
  • LV
Лекарство: fluorouracil
Patients receive fluorouracil 2000 mg/m^2 (iv, 24 hours) on days 1, 8, 15 and 22 for 4 weeks, followed by 2 weeks without treatment. Treatment repeats until there is disease progression or recurrence.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Overall survival
Временное ограничение: From date of enrollment until the date of death from any cause, assessed 2 cycles during the therapy and 3 months thereafter up to 24 months; Cycle 1 (each cycle is 28 days for AG regimen and 42 days for OFF regimen).
To evaluate the therapeutic efficacy of second-line adjuvant therapy with AG versus OFF in terms of overall survival for gemcitabine-refractory pancreatic cancer after curative resection. Outpatient visit, phone interview
From date of enrollment until the date of death from any cause, assessed 2 cycles during the therapy and 3 months thereafter up to 24 months; Cycle 1 (each cycle is 28 days for AG regimen and 42 days for OFF regimen).

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Objective Response Rate
Временное ограничение: Complete Remission% + Partial Remission %, assessed 2 cycles during the therapy and 3 months thereafter up to 24 months; Cycle 1 (each cycle is 28 days for AG regimen and 42 days for OFF regimen).
To evaluate the therapeutic efficacy of two regimens in terms of objective response rate. Computed tomography (CT) scan
Complete Remission% + Partial Remission %, assessed 2 cycles during the therapy and 3 months thereafter up to 24 months; Cycle 1 (each cycle is 28 days for AG regimen and 42 days for OFF regimen).
Time to Remission
Временное ограничение: From date of enrollment until the date of remission, assessed 2 cycles during the therapy and 3 months thereafter up to 24 months; Cycle 1 (each cycle is 28 days for AG regimen and 42 days for OFF regimen).
To evaluate the time to remission of patients treated with the two regimens. Computed tomography (CT) scan
From date of enrollment until the date of remission, assessed 2 cycles during the therapy and 3 months thereafter up to 24 months; Cycle 1 (each cycle is 28 days for AG regimen and 42 days for OFF regimen).
Progression-Free Survival
Временное ограничение: From date of enrollment until the date of first documented progression, assessed 2 cycles during the therapy and 3 months thereafter up to 24 months; Cycle 1 (each cycle is 28 days for AG regimen and 42 days for OFF regimen).
To evaluate the progression-free survival of patients treated with the two regimens. Computed tomography (CT) scan
From date of enrollment until the date of first documented progression, assessed 2 cycles during the therapy and 3 months thereafter up to 24 months; Cycle 1 (each cycle is 28 days for AG regimen and 42 days for OFF regimen).
The Levels of Tumor Biomarkers in Serum
Временное ограничение: 2 cycles during the therapy and 3 months thereafter up to 24 months; Cycle 1 (each cycle is 28 days for AG regimen and 42 days for OFF regimen).
To evaluate the levels of tumor biomarkers in serum of patients treated with the two regimens, including Carbohydrate Antigen (CA)19-9、CA125、CA153、CA242、CA72-4、CA50、CEA、AFP . Outpatient visit, laboratory findings
2 cycles during the therapy and 3 months thereafter up to 24 months; Cycle 1 (each cycle is 28 days for AG regimen and 42 days for OFF regimen).
Number of grade 3 and 4 toxicities according to NCI CTCAE version 4.0
Временное ограничение: 1 week during therapy and 3 months thereafter up to 24 months.
To evaluate the occurrence of grade 3 and 4 toxicities according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE; version 4.0) in patients treated with the two regimens. The toxicity profile includes but not limits neutropenia, thrombocytopenia, peripheral neuropathy, hypoglycemia, metabolic acidosis (acute or chronic, including ketoacidosis), which will be summarized as the percentage of patients by type and grade according to treatment group. Outpatient visit, laboratory findings.
1 week during therapy and 3 months thereafter up to 24 months.
Quality of life
Временное ограничение: 2 cycles during the therapy and 3 months thereafter up to 24 months; Cycle 1 (each cycle is 28 days for AG regimen and 42 days for OFF regimen).
To evaluate the quality of life score of patients treated with the two regimens. Outpatient visit, phone interview
2 cycles during the therapy and 3 months thereafter up to 24 months; Cycle 1 (each cycle is 28 days for AG regimen and 42 days for OFF regimen).

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Fudan University

Следователи

  • Главный следователь: Xian-Jun Yu, M.D PH.D, Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University; 270 Dong An Road, Shanghai 200032, China

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 июня 2015 г.

Первичное завершение (Ожидаемый)

1 декабря 2018 г.

Завершение исследования (Ожидаемый)

1 июня 2019 г.

Даты регистрации исследования

Первый отправленный

18 июля 2015 г.

Впервые представлено, что соответствует критериям контроля качества

22 июля 2015 г.

Первый опубликованный (Оценивать)

23 июля 2015 г.

Обновления учебных записей

Последнее опубликованное обновление (Оценивать)

11 августа 2016 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

10 августа 2016 г.

Последняя проверка

1 августа 2016 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • CSPAC-010

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Клинические исследования nab-paclitaxel

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