Erlotinib, Gemcitabine and Nab-Paclitaxel in Advanced Pancreatic Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( OSI Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01010945
First received: November 6, 2009
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Advanced Pancreatic Cancer
Drug: erlotinib
Drug: gemcitabine
Drug: nab-paclitaxel
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase IB Study of Erlotinib in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Previously Untreated Advanced Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Maximum Tolerated Dose [ Time Frame: Monthly (to a maximum of 12 months) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety of drug combination assessed through dose limiting toxicities (DLTs) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Safety of drug combination assessed through Adverse Events (AEs) [ Time Frame: Monthly (to a maximum of 12 months) ] [ Designated as safety issue: No ]
  • Evaluate erlotinib Pharmacokinetic (PK) trough concentrations (C24h) [ Time Frame: Days 29 (Cycle 2, Day 1) and 30 ] [ Designated as safety issue: No ]
  • Objective Response Rate [ Time Frame: Monthly (to a maximum of 12 months) ] [ Designated as safety issue: No ]
    Response will be based on the RECIST v1.1 criteria. Patients with partial and complete response will be classified as "responders".

  • Progression Free Survival (PFS) [ Time Frame: Monthly (to a maximum of 12 months) ] [ Designated as safety issue: No ]
    PFS will be calculated as the time from start of treatment until disease progression or death; patients who are still alive and free of progression at their last follow-up will be censored at that time.

  • Overall Survival [ Time Frame: Monthly (to a maximum of 12 months) ] [ Designated as safety issue: No ]
    Survival will be calculated as the time from start of treatment until death of any cause, patients who are still alive at their last follow-up will be censored at that time.


Enrollment: 19
Study Start Date: December 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: erlotinib, gemcitabine, nab-paclitaxel Drug: erlotinib
administered orally
Other Names:
  • Tarceva
  • OSI-774
Drug: gemcitabine
administered intravenously
Drug: nab-paclitaxel
administered intravenously

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01010945

Locations
United States, California
Desert Comprehensive Cancer Center
Palm Springs, California, United States, 92262
United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27514
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
OSI Pharmaceuticals
Investigators
Study Director: Medical Monitor Astellas Pharma Global Development
  More Information

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Inc ( OSI Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01010945     History of Changes
Other Study ID Numbers: OSI-774-108, 09PAN01
Study First Received: November 6, 2009
Last Updated: June 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Advanced Pancreatic Cancer
erlotinib
gemcitabine
nab-paclitaxel
Adenocarcinoma
Phase 1b

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Paclitaxel
Gemcitabine
Erlotinib
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014