Clinical trial NCT02272738: A Study of Chemoradiotherapy Using Gem Plus Nab-paclitaxel for Pancreatic Cancer
Official title: A Phase I Study of Chemoradiotherapy Using Gemcitabine Plus Nab-paclitaxel for Unresectable Locally Advanced Pancreatic Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pancreatic Cancer
Lead sponsor: Osaka Medical Center for Cancer and Cardiovascular Diseases
Sponsor class: OTHER
First posted: 2014-10-23
Enrollment: 54
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the clinical safety and efficacy of Gemcitabine plus nab-Paclitaxel chemoradiotherapy and to determine the Maximal Tolerated Dose (MTD) for unresectable locally advanced pancreatic adenocarcinoma.

Detailed description: Gemcitabine plus nab-Paclitaxel is one of the standard chemotherapy for metastatic pancreatic adenocarcinoma. Gemcitabine plus nab-Paclitaxel realize the favorable anti-tumor effect and tolerable toxicity. Gemcitabine plus nab-Paclitaxel is a promising regimen for concurrent chemoradiotherapy, but the investigators need to know the safety in the case of the concurrent chemoradiotherapy.

Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed advanced pancreatic cancer
* Locally advanced pancreatic cancer is defined as the presence of a surgically unresectable tumor(involving the celiac axis or the superior mesenteric artery)
* Performance Status:0-1(ECOG)
* Patients of age =\>20 and 75\>
* White Blood Cell (WBC) \>=3,500/mm3,12,000/mm3,

  * Neutrophils \>=1,500/mm3, platelets=100,000/mm3,
  * Hemoglobin \>=9.5 g/dl,
  * GOT \</=2.0 X Upper Limit Number (ULN),
  * Glutamate Pyruvate Transaminase (GPT) \</=2.0 X ULN,
  * Alkaline Phosphatase (ALP) \</=2.0 X ULN,
  * Total bilirubin \<=1.5mg/dl,
  * Serum creatinine \<=1.2mg/dl,
  * Creatinine clearance\>=50 ml/min
  * arterial O2 pressure (PaO2) \>=70torr or arterial O2 saturation (SpO2) \>=96%
* Life expectancy more than 3 months.
* Written informed consent.

Exclusion Criteria:

* Active infection
* Lung fibrosis or intestinal pneumonia detectable on chest X-ray and CT
* Severe complication (heart disease, cirrhosis, diabetes)
* Myocardial infarction within 3 months
* Active synchronous or metachronous malignancy
* Pregnant or lactation women, or women with known or suspected pregnancy
* Symptomatic brain metastasis
* History of severe drug allergy
* Peripheral neuropathy
* Patients who are judged inappropriate for the entry into the study by the investigator

Primary outcomes:
measure: Number of patients with Adverse Events
timeFrame: 1 years
Secondary outcomes:
measure: Response Rate
timeFrame: 1 years
measure: Overall Survival time
timeFrame: 2 years
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Osaka Medical Center for Cancer and Cardiovascular Diseases
Study officials:
affiliation: Osaka Medical Center for Cancer and Cardiovascular Diseases
name: Tatsuya Ioka, MD
role: STUDY_DIRECTOR
References: