Phase 2 Nab® -Paclitaxel (Abraxane®) Plus Gemcitabine in Subjects With Locally Advanced Pancreatic Cancer (LAPC)

• Status: Completed
• Trial end date: 2018-04-26
• Target enrollment: 0
• Participant gender: All

Summary

This clinical study is in subjects who are 18 years old or older with locally advanced pancreatic cancer who have not received prior treatment for their pancreatic cancer. The study treats all subjects with nab-Paclitaxel plus gemcitabine for approximately 6 months of treatment. Subjects who complete the treatment will choose, with their treating physicians, what additional treatment should be given: more nab-Paclitaxel plus gemcitabine, Chemoradiation therapy, or surgery to treat the locally advanced pancreatic cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene; Celgene Corporation
• Treatments: Albumin-Bound Paclitaxel; Capecitabine; Gemcitabine; Paclitaxel

Criteria

Inclusion Criteria:

• Non- metastasis, unresectable, adenocarcinoma pancreatic cancer patients

• No prior anticancer therapy for pancreatic cancer

•≥ 18 years of age with a performance status of 0 or 1•Adequate complete blood counts, hepatic function, and renal function

• Signed informed Consent

Exclusion Criteria:

• Active bacterial, viral, or fungal infection

• Infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection, or receiving immunosuppressive or myelosuppressive

• Subjects with sensory neuropathy, ascites, or plastic biliary stent.

• Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders (including but not limited to connective tissue disorders, lung disease, and cardiac or seizure disorders)

• Women who are pregnant or breast feeding