EUCTR2014-004086-24-DE进行中（未招募）1 期
Induction Treatment with nab-Paclitaxel/Gemcitabine for First-line Treatment of Metastatic Pancreatic Cancer Followed by Either Alternating Application of Gemcitabine Monotherapy and nab-Paclitaxel/Gemcitabine or Continuing Application of nab-Paclitaxel/Gemcitabine: A Randomized Phase II Study - ALPACA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 325
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Adult patients (= 18 years of age)
- •- Histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. Patients with islet cell neoplasms are excluded.
- •- Karnofsky performance status (KPS) = 70%
- •- At least one unidimensionally measurable lesion as assessed by CT-scan or MRI according to RECIST 1.1
- •- Total bilirubin = 1.5 x ULN. Patients with a biliary stent may be included provided that bilirubin level after stent insertion decreased to = 1.5 x ULN and there is no cholangitis.
- •- Adequate renal, hepatic and bone marrow function, defined as
- •? Calculated creatinine clearance = 30 mL/min according to CKD-EPI formula
- •? AST/GOT and/or ALT/GPT = 2.5 x ULN and = 5.0 x ULN in case of liver metastasis
- •? Absolute neutrophil count (ANC) = 1.5 x 10^9/L
- •? Haemoglobin = 9 g/dL
- •? Platelets = 100 x 10^9/L
- •- Females of childbearing potential (FCBP) must have a negative serum pregnancy test within 7 days of the first application of study treatment and they must agree to undergo further pregnancy tests before randomization and at the end of treatment visit
- •FCBP must either agree to use and be able to take effective contraceptive birth control measures (Pearl Index < 1) or agree to practice complete abstinence from heterosexual intercourse during the course of the study and for at least 1 month after last application of study treatment.
- •A female subject is considered to be of childbearing potential unless she is age = 50 years and naturally amenorrhoeic for = 2 years, or unless she is surgically sterile.
- •- Males must agree not to father a child during the course of the trial and for at least 6 months after last administration of study drugs.
- •- Signed and dated informed consent before the start of any specific protocol procedures
- •- Patient’s legal capacity to consent to study participation
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 325
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 325
排除标准
- •- Missing histological or cytological confirmation of metastatic adenocarcinoma of the pancreas
- •- Locally advanced pancreatic adenocarcinoma without metastases
- •- Any previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. (Prior adjuvant chemotherapy with gemcitabine or fluoropyrimidine in curative intent is allowed if terminated more than 6 months before first application of study treatment. Previous palliative radiotherapy of bone metastases for alleviation of pain is permitted provided that irradiated bone metastases are no target lesions.)
- •- Known brain metastase/brain metastases. Brain imaging is required in symptomatic patients to rule out brain metastases, but is not required in asymptomatic patients.
- •- Pre-existing polyneuropathy = grade 2 according to CTCAE version 4
- •- Medical history of interstitial lung disease (ILD) or pulmonary fibrosis
- •- Patients with high cardiovascular risk, including, but not limited to, recent coronary stenting or myocardial infarction in the past year
- •- Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus)
- •- Any other severe concomitant disease or disorder, which could influence patient’s ability to participate in the study and his/her safety during the study or interfere with interpretation of study results e.g. severe hepatic, renal, pulmonary, metabolic, or psychiatric disorders
- •- Previous or concurrent tumor other than underlying tumor disease (pancreatic cancer) with the exception of cervical cancer in situ, adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder tumors (Ta, Tis, and T1) or any curatively treated tumors > 5 years prior to enrolment
- •- Hypersensitivity against nab-paclitaxel, gemcitabine, or any excipients of these drugs
- •- Continuing abuse of alcohol, drugs, or medical drugs
- •- Pregnant females, breast feeding females or females of childbearing potential unable to either perform adequate contraceptive measures or practice complete abstinence from heterosexual intercourse
- •- Participation in any other clinical trial or treatment with any experimental drug within 28 days before enrolment to the study or during study participation until the end of treatment visit
研究者
相似试验
已完成
1 期
Phase 1 trial of Nab-paclitaxel and Gemcitabine for metastatic breast cancerBreast cancerJPRN-UMIN000010125Tokyo-West Tokushukai Hospital6
已完成
1 期
Phase I trial of Gemcitabine plus nab-Paclitaxel for metastatic breast cancerBreast cancerJPRN-UMIN000009067Okayama Univesity Hospital9
已完成
不适用
eoadjuvant nab-paclitaxel plus gemcitabine therapy for resectable pancreatic cancer; A phase II multicenter trialResectable pancreatic cancerJPRN-UMIN000031822Hokkaido Pancreatic Cancer Study Group (HOPS)50
进行中（未招募）
2 期
eoadjuvant nab-paclitaxel plus gemcitabine therapy for resectable pancreatic cancer; A phase II multicenter trialJPRN-jRCT1011180032Hirano Satoshi50
已完成
不适用
Phase I study of nab-paclitaxel and gemcitabine chemoradiotherapy for borderline resectable and locally advanced unresectable pancreatic ductal adenocarcinomapancreatic cancerJPRN-UMIN000030551Mie university15