Erlotinib, Gemcitabine and Nab-Paclitaxel in Advanced Pancreatic Cancer

• Status: Completed
• Trial end date: 2012-01-25
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 1b study to evaluate the combination of gemcitabine and Tarceva (erlotinib) and nab-paclitaxel in patients with advanced pancreatic cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OSI Pharmaceuticals
• Treatments: Albumin-Bound Paclitaxel; Erlotinib Hydrochloride; Gemcitabine; Paclitaxel

Criteria

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1

• Predicted life expectancy of >= 12 weeks

• Previous surgery

• Histologically or cytologically confirmed, measurable, locally advanced, unresectable or metastatic pancreatic adenocarcinoma

• No prior therapy for pancreatic cancer

• Adequate organ and marrow function

• Absolute neutrophil count >= 1.5 x 10^9/L

• Platelets >= 100 x 10^9/L

• Total bilirubin <= institutional upper limits of normal

• AST (SGOT)/ALT(SGPT) <= 2 x institutional upper limits of normal

• Serum creatinine <= 1.5 x upper limits of normal

• Negative pregnancy test

• Informed consent

• Patient must agree not to smoke while on study

Exclusion Criteria:

• Significant history of cardiac disease unless the disease is well controlled

• Active or uncontrolled infections or serious illness or medical conditions that could interfere with the patient's ongoing participation in study

• History of any psychiatric condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent

• History of smoking within the previous 14 days before enrollment or positive cotinine test at baseline

• Pregnant or breast-feeding females

• Symptomatic brain metastases that are not stable, that require steroids, that are potentially life-threatening, or that have required radiation within the last 14 days

• History of allergic reactions attributed to compounds of similar chemical or biological composition to the study drugs