Pancreatic Cancer
Conditions
Keywords
Metastatic pancreatic cancer, Second Line treatment, Gemcitabine, Nab-paclitaxel
Brief summary
A Phase II trial of gemcitabine plus nab-paclitaxel in the second line setting
Detailed description
This is an open label Phase II study to evaluate the clinical activity of the combination of gemcitabine and nab-paclitaxel (abraxane) as second line treatment in patients with metastatic pancreatic cancer who have received non-gemcitabine-based chemotherapy in the first line setting. All patients will receive both drugs on Days 1, 8, 15 every 28 days. The hypothesis is that this combination will have a 4-month progression free survival of 70% or higher.
Interventions
Gemcitabine 1000 mg/m2 followed by abraxane 125 mg/m2 administered intravenously on days 1, 8, and 15 every 28 days
Sponsors
Georgetown University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed metastatic adenocarcinoma of the pancreas * Progression on first line non-gemcitabine based therapy for metastatic or relapsed disease * Radiographically measurable or evaluable disease * Age \>/= 18 years * ECOG performance status 0-2 * Adequate hepatic, bone marrow and renal function
Exclusion criteria
* Prior gemcitabine-based chemotherapy in the first line setting * No active severe infection, or known chronic infection with HIV or hepatitis B virus * No cardiovascular disease problems including unstable angina, therapy for life-threatening ventricular arrhythmia, or myocardial infarction, stroke, or congestive heart failure within the last 6 months * No women who are pregnant or breastfeeding, and no women of childbearing potential without using dual forms of contraception * Patients with known CNS metastases * History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine or nab-paclitaxel * Anticipated patient survival under 2 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 4 month progression free survival | 2.5 years | The proportion of patients at 4 months from study entry with progression or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate | 2.5 years | Confirmed classification of stable disease, partial response or complete response by RECIST 1.1 criteria |
| Progression Free Survival | 2.5 years | The time in days from study entry until progression or death |
| Overall Survival | 3 years | The time in days from study entry until death |
Countries
United States
Outcome results
None listed