Nab-paclitaxel Plus Gemcitabine in Chinese Patients With Advanced Pancreatic Cancer

• Status: Unknown status
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) plus gemcitabine as first-line treatment in Chinese patients with advanced pancreatic ductal adenocarcinoma.

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

Details

• Lead Sponsor: Chinese PLA General Hospital
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine; Paclitaxel

Criteria

Inclusion Criteria:

1. Signed informed-consent form.

2. Age no less than 18 years.

3. Histologically confirmed locally advanced or metastatic pancreatic ductal adenocarcinoma, with RECIST measurable lesions.

4. Eastern Cooperative Oncology Group (ECOG) 0-1 with life expectation of no less than 12 weeks.

5. Patients must have received no previous chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatment with 5-fluorouracil or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present.

6. Adequate liver/bone marrow function.

7. Human Chorionic Gonadotropin (HCG) test negative for female with contraception measure until 3 months after study end.

8. Compliant, and can be followed up regularly.

Exclusion Criteria:

1. Pregnant or breast-feeding female, or not willing to take contraception measures during study.

2. Serious infection requiring antibiotics intervention during recruitment.

3. Allergic to study drug.

4. More than grade 1 neuropathy.

5. Uncontrolled brain metastasis or mental illness.

6. Congestive heart failure, uncontrolled cardiac arrhythmia, etc.

7. Other malignancy within 5 years.

8. Can't be followed up or obey protocol.

9. Ineligible by the discretion of the investigator.