Metastatic Adenocarcinoma of the Pancreas, Recurrent Adenocarcinoma of the Pancreas
Conditions
Keywords
Chemotherapy, Gemcitabine, Recurrent and metastatic adenocarcinoma of the pancreas, Genexol-PM, Paclitaxel
Brief summary
Phase II Study of Weekly Genexol®-PM Plus Gemcitabine in Subjects With Recurrent and Metastatic Adenocarcinoma of the Pancreas.
Detailed description
The aim of the this phase II study is to assess the efficacy and safety of a combination treatment of Genexol®-PM plus gemcitabine in patients with recurrent and metastatic adenocarcinoma of the pancreas.
Interventions
DRUGGenexol-PM
125 mg/m2 given intravenously over 60 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity.
DRUGGemcitabine
1000 mg/m2 given intravenously for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity.
Sponsors
Samyang Biopharmaceuticals Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient has definitive histologically or cytologically confirmed recurrent and metastatic adenocarcinoma of the pancreas. The definitive diagnosis of recurrent and metastatic pancreatic adenocarcinoma will be made by integrating the histopathological data within the context of the clinical and radiographic data. Patients with islet cell neoplasms are excluded. 2. Initial diagnosis of recurrent and metastatic disease must have occurred ≤6 weeks prior to randomization in the study. 3. Patient has one or more lesions measurable by CT scan or MRI (if patient is allergic to CT contrast media). 4. Male or non-pregnant and non-lactating female, and ≥ 20 years of age. 5. Patient must meet the following blood counts at Baseline (obtained ≤14 days prior to randomization): * Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L * Platelet count ≥ 100,000/mm3 (100 × 10\^9/L) * Hemoglobin (Hgb) ≥ 9 g/dL. 6. Patient has the following blood chemistry levels at Baseline (obtained ≤14 days prior to randomization): * AST (SGOT), ALT (SGPT) ≤ 2.5 × upper limit of normal range (ULN), unless liver metastases are clearly present, then ≤ 5 × ULN is allowed. * Total bilirubin ≤ULN 7. Patient has a Karnofsky performance status (KPS) ≥ 70. Two observers will be required to assess KPS. If discrepant, the one with the lowest assessment will be considered true. 8. Patient has voluntarily agreed to participate in the study, and signed the Informed Consent Form (ICF) prior to participation in any study-related activities.
Exclusion criteria
1. History of malignancy in the last 5 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible if they were cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 5 years. 2. Patients have uncontrolled bacterial, viral, or fungal infections 3. Patient has known historical or active infection with HIV, hepatitis B, or hepatitis C. 4. Patients have a history of allergy or hypersensitivity to any of Paclitaxel, Gemcitabine, or Cremophor EL. 5. Patients with high cardiovascular risk, including recent coronary stenting or myocardial infarction in the past 6 months. 6. History of Peripheral Artery Disease (e.g,. claudication, Leo Buerger's disease).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) as assessed by RECIST. | 8 weeks | ORR will be summarized as the percentage of participants who achieved a confirmed complete (CR) or partial response (PR) using RECIST guidelines. Response is confirmed at least 4 weeks later. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) | 2 years | Time from the date of enrollment until the date of objective disease progression or the date of death. PFS will be summarized using Kaplan-Meier methods. |
| Overall survival (OS) | 2 years | OS will be summarized using Kaplan-Meier methods. |
| Disease control rate (DCR) | 8 weeks | DCR is defined as the percentage of patients who have achieved complete response, partial response and stable disease |
| Number of participants with adverse events | Baseline up to Day 21 after the last dose of study treatment | A adverse event (AE) is as any AE occurring or worsening on or after the first treatment of any study drug, and within 21 days after the last dose of the last study drug. Severity grades according to NCI CTCAE version 4.0. |
Countries
South Korea
Outcome results
None listed