Metastatic Pancreatic Cancer Clinical Trial
Official title:
Randomized Phase II Study of Weekly ABI-007 Plus Gemcitabine or Simplified LV5FU2 as First-line Therapy in Patients With Metastatic Pancreatic Cancer
To evaluate the combination of ABI-007 with gemcitabine or with LV5FU2.
Gemcitabine alone or the triplet combination of 5FU, irinotecan and oxaliplatin
(FOLFIRINOX)are the reference 1st line treatment for metastatic pancreatic cancer.
The aim of the AFUGEM study is to evaluate the efficacy of weekly ABI-007 in combination
with weekly gemcitabine or with fortnightly simplified LV5FU2 regimen in terms of
progression-free survival in patients with previously untreated metastatic pancreatic
cancer.
ABI-007 has been approved for commercialization in 38 countries, including the US, Canada,
the EU, Australia, China, India and Korea for the treatment of women with metastatic breast
cancer. ABI-007 alone and in combination is being evaluated in a number of cancers,
including metastatic melanoma, non-small cell lung cancer, pancreatic cancer, and other
solid tumors. Conditions which are responsive to paclitaxel such as non-hematological solid
tumor malignancies are good clinical candidates for treatment with ABI-007.
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