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Pancreatic Cancer

ABI-007 for Metastatic Adenocarcinoma of the Pancreas (FHCRC-2350)
A Randomized Phase III Study of Weekly ABI-007 (Abraxane) plus Gemcitabine (Gemzar) versus Gemcitabine Alone in Patients with Metastatic Adenocarcinoma of the Pancreas
Status Conditions Phase Study ID
Closed Pancreatic Cancer Phase III 2350.00
NCT00844649
Summary
The purpose of this study is to find out if the study drug ABI-007 given together with another drug, Gemcitabine (a drug approved for the treatment of pancreatic cancer), is as safe and effective as Gemcitabine alone in patients with metastatic pancreas cancer.

ABI-007 is also known as Abraxane® and is approved by the FDA for the treatment of certain types of breast cancer. Participants in this study will either get ABI-007 plus Gemcitabine treatment, or Gemcitabine treatment alone. Participants will be assigned randomly to one of two treatment groups.

Participants will receive study treatment at the Seattle Cancer Care Alliance (SCCA). If hospitalization is needed while in Seattle, participants will be admitted to the University of Washington Medical Center (UWMC).

There are typically 3 treatment visits per month during the course of the study. Patients are monitored weekly for the development of any side effects.


Investigator
Sunil Hingorani, MD, PhD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)

• 18 years of age or older

• Diagnosed with metastatic pancreas cancer

• One or more metastatic tumors

• No previous therapy for treatment of metastatic disease

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

• Previously treated for metastatic pancreas cancer

• Pregnant or breastfeeding

• Known brain metastases unless previously treated and well-controlled for at least 3 months

• Use of Coumadin

• Active, uncontrolled infection requiring systemic therapy

• Known historical or active infection with HIV, hepatitis B or C

• History of connective tissue disorders (e.g., lupus, scleroderma, arteritis nodosa)

• History of chronic leukemias (e.g., chronic lymphocytic leukemia)

• Patients with high cardiovascular risk, including, but not limited to, recent coronary stenting or myocardial infarction in the past year

• History of Peripheral Artery Disease (e.g,. claudication, Buerger's disease)

Other exclusion criteria may apply.

Last Updated
June 05, 2013
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.