Erlotinib, Gemcitabine and Nab-Paclitaxel in Advanced Pancreatic Cancer

OSI Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Advanced Pancreatic Cancer

Treatments: Drug: gemcitabine; Drug: nab-paclitaxel; Drug: erlotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01010945

OSI-774-108

09PAN01 (Other Identifier)

Details and patient eligibility

About

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

Full description

This is a single-arm, phase 1b study to determine the maximum tolerated dose (MTD) of the combination of erlotinib (daily), gemcitabine (weekly), nab-paclitaxel (weekly) in patients with advanced pancreatic cancer.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

erlotinib, gemcitabine, nab-paclitaxel

Experimental group

Description:

Patients receive the following treatment in 28-day cycles: 1) erlotinib: orally once daily from days 1 through 28 continuous dosing; 2) gemcitabine (following nab-paclitaxel): intravenously over 30 minutes on days 1, 8 and 15 every 28 days; and 3) nab-paclitaxel: intravenously over 30 minutes on days 1, 8 and 15 every 28 days.

Treatment:

Drug: erlotinib

Drug: nab-paclitaxel

Drug: gemcitabine