NCT01964534

Efficacy of ABI-007 Plus Gemcitabine or sLV5FU2 as First-line Therapy in Patients With Metastatic Pancreatic Cancer

Randomized Phase II Study of Weekly ABI-007 Plus Gemcitabine or Simplified LV5FU2 as First-line Therapy in Patients With Metastatic Pancreatic Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the combination of ABI-007 with gemcitabine or with LV5FU2.

Detailed description

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.

Conditions

• Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	ABI-007	ABI-007 : 125 mg/m² IV /30min (day 1, day 8, day 15)
DRUG	Gemcitabine	1000 mg/m² IV /30min (day 1, day 8, day 15)
DRUG	simplified LV5FU2	Folinic acid: 400 mg/m² IV /2h (day 1, day 15) Bolus 5-FU: 400 mg/m² IV /15min (day 1, day 15) 5-FU infusion: 2400 mg/m² IV /46h (day 1-2, day 15-16)

Timeline

• Start date: 2013-12-12
• Primary completion: 2017-02-01
• Completion: 2017-07-01
• First posted: 2013-10-17
• Last updated: 2017-01-31

Locations

15 sites across 1 country: France