Erlotinib, Gemcitabine and Nab-Paclitaxel in Advanced Pancreatic Cancer

O

OSI Pharmaceuticals

Status and phase

Completed
Phase 1

Conditions

Advanced Pancreatic Cancer

Treatments

Drug: erlotinib
Drug: gemcitabine
Drug: nab-paclitaxel

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)

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: nab-paclitaxel
Drug: gemcitabine
Drug: erlotinib

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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