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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated 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 Diseases Gastrointestinal Neoplasms Paclitaxel Albumin-Bound Paclitaxel

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1). Subjects with neuroendocrine (and mixed type) tumors are excluded.
  2. Pancreatic cancer surgical staging: T 1-3, N0-1, M0.
  3. Subject should be able to start treatment no later than 12 weeks postsurgery.
  4. ≥18 years of age at the time of signing the informed consent form (ICF).
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  6. Acceptable hematology parameters:
  7. Absolute neutrophil count ≥1500 cell/mm3
  8. Platelet count ≥100,000/mm3
  9. Hemoglobin (Hgb) ≥9 g/dL
  10. Acceptable blood chemistry levels:
  11. 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)
  12. Total bilirubin ≤ Upper Limit of Normal (ULN) (subjects with Gilbert's syndrome can have bilirubin of up to 1.5 x ULN)
  13. Alkaline phosphatase ≤ 2.5 x ULN
  14. 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
  15. Cancer antigen (CA)19-9 <100 U/mL assessed within 14 days of randomization
  16. 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:

  1. Prior neo-adjuvant treatment or radiation therapy for pancreatic adenocarcinoma
  2. Presence of or history of metastatic pancreatic adenocarcinoma
  3. 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)
  4. 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
  5. 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
  6. History of allergy or hypersensitivity to nab-paclitaxel or gemcitabine or any of their excipients
  7. 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:
  8. History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa)
  9. History of interstitial lung disease, slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies
  10. 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

  • University of California, San Francisco Cutaneous Oncology and Melanoma Center
    San Francisco, California, 9411, United States
  • UC Davis Cancer Center
    Sacramento, California, 95817, United States
  • University of California Los Angeles
    Santa Monica, California, 90404, United States
  • University of Southern California
    Los Angeles, California, 90033, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
ID
NCT01964430
Phase
Phase 3
Lead Scientist
Andrew Ko
Study Type
Interventional
Last Updated
August 31, 2017