Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (the "Apact" Study)
a study on Pancreatic Cancer Digestive System Tumor Neoplasms by Site Neoplasms Endocrine Gland Tumor Pancreatic Diseases Digestive System Diseases Endocrine System Diseases Gemcitabine Antimetabolites, Antineoplastic
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UC Davis UCLA UCSD UCSF
- Dates
- study startedestimated completion
Description
Summary
The purpose of this study is to compare whether there is a delay or prevention of recurrence or death in subjects with surgically removed pancreatic cancer who then take nab-paclitaxel in combination with gemcitabine compared to those who take gemcitabine alone.
Official Title
A Phase 3, Multicenter, Open-label, Randomized Study of Nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine Alone as Adjuvant Therapy in Subjects With Surgically Resected Pancreatic Adenocarcinoma
Details
ABI-007-PANC-003 is a Phase 3, international, multicenter, randomized, open-label, controlled study that will compare the efficacy of nab-paclitaxel in combination with gemcitabine to gemcitabine alone as adjuvant treatment for 6 cycles in patients with surgically resected pancreatic adenocarcinoma.
Keywords
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Pancreatic Diseases Digestive System Diseases Endocrine System Diseases Gemcitabine Antimetabolites, Antineoplastic Resectable pancreatic cancer resected resectable PDA adenocarcinoma surgically resected adjuvant Abraxane nab-paclitaxel ABI-007 Gemzar Phase 3 Gastrointestinal Neoplasms Gastrointestinal Diseases Paclitaxel Albumin-Bound Paclitaxel nab-Paclitaxel 125 mg/m2 gemcitabine 1000 mg/m2 nab-Paclitaxel 125 mg/m2 plus gemcitabine 1000 mg/m2
Eligibility
You can join if…
Open to people ages 18 years and up
- Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1). Subjects with neuroendocrine (and mixed type) tumors are excluded.
- Pancreatic cancer surgical staging: T 1-3, N0-1, M0.
- Subject should be able to start treatment no later than 12 weeks postsurgery.
- ≥18 years of age at the time of signing the informed consent form (ICF).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Acceptable hematology parameters:
- Absolute neutrophil count ≥1500 cell/mm3
- Platelet count ≥100,000/mm3
- Hemoglobin (Hgb) ≥9 g/dL
- Acceptable blood chemistry levels:
- Aspartate aminotransferase (AST)/ Serum glutamic oxaloacetic transaminase (SGOT) and Alanine transaminase (ALT)/ Serum glutamic -pyruvic transaminase (SGPT) ≤2.5 × upper limit of normal range (ULN)
- Total bilirubin ≤ Upper Limit of Normal (ULN) (subjects with Gilbert's syndrome can have bilirubin of up to 1.5 x ULN)
- Alkaline phosphatase ≤ 2.5 x ULN
- Serum creatinine within upper limits of normal or calculated clearance ≥50 mL/min/1.73 m2. If using creatinine clearance, actual body weight should be used for calculating creatinine clearance (eg, using the Cockroft-Gault formula). For subjects with a Body Mass Index (BMI) >30 kg/m2, lean body weight should be used instead
- Cancer antigen (CA)19-9 <100 U/mL assessed within 14 days of randomization
- Acceptable coagulation studies as demonstrated by Prothrombin Time (PT) and Partial Thromboplastin Time (PTT) within normal limits (±15%)
You CAN'T join if...
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- Prior neo-adjuvant treatment or radiation therapy for pancreatic adenocarcinoma
- Presence of or history of metastatic pancreatic adenocarcinoma
- Any other malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, or nonmelanomatous skin cancer (all treatment of which should have been completed 6 months prior to randomization)
- Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment
- Known infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection, or subject receiving immunosuppressive or myelosuppressive medications that would in the opinion of the investigator, increase the risk of serious neutropenic complications
- History of allergy or hypersensitivity to nab-paclitaxel or gemcitabine or any of their excipients
- Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders, which could compromise the subject's safety or the study data integrity. These include, but are not limited to:
- History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa)
- History of interstitial lung disease, slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies
- History of the following within 6 months prior to Cycle 1 Day 1: a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or ECG abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder
Locations
- UCSD Moores Cancer Center
La Jolla California 92093 United States - UC Davis Cancer Center
Sacramento California 95817 United States - University of California, San Francisco Cutaneous Oncology and Melanoma Center
San Francisco California 9411 United States - University of California Los Angeles
Santa Monica California 90404 United States
Details
- Status
- in progress, not accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Celgene
- ID
- NCT01964430
- Phase
- Phase 3
- Study Type
- Interventional
- Last Updated