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CompletedNCT01010945Updated Nov 21, 2024

Erlotinib, Gemcitabine and Nab-Paclitaxel in Advanced Pancreatic Cancer

A Phase 1 interventional study of erlotinib and gemcitabine in Advanced Pancreatic Cancer, sponsored by OSI Pharmaceuticals. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-21.

Sponsored by OSI Pharmaceuticals (part of Astellas Pharma Inc) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
19
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Advanced Pancreatic Cancer

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Keywords

  • erlotinib
  • nab-paclitaxel
  • gemcitabine
  • Adenocarcinoma
  • Advanced Pancreatic Cancer
  • Phase 1b
03

In context

Adenocarcinoma

1,996 studies on the registry are indexed under Adenocarcinoma; 369 are open to participants now.

This study's enrollment of 19 is below the median of 44 across 1,549 interventional studies indexed under Adenocarcinoma.

Browse Adenocarcinoma studies →

Lead sponsor

OSI Pharmaceuticals is the lead sponsor of 16 studies on the registry; none are open to participants now.

First submitted before OSI Pharmaceuticals became part of Astellas Pharma Inc.

Browse OSI Pharmaceuticals studies →All Astellas Pharma Inc studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    erlotinib, gemcitabine, nab-paclitaxel

    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.

    Drug: erlotinib · Drug: gemcitabine · Drug: nab-paclitaxel

Interventions

06

What researchers measure

Primary outcomes

  1. Maximum Tolerated Dose

    Time frame: Monthly (to a maximum of 12 months)

Secondary outcomes

  1. Safety of drug combination assessed through dose limiting toxicities (DLTs)

    Time frame: 1 month

  2. Safety of drug combination assessed through Adverse Events (AEs)

    Time frame: Monthly (to a maximum of 12 months)

  3. Evaluate erlotinib Pharmacokinetic (PK) trough concentrations (C24h)

    Time frame: Days 29 (Cycle 2, Day 1) and 30

  4. Objective Response Rate

    Response will be based on the RECIST v1.1 criteria. Patients with partial and complete response will be classified as "responders".

    Time frame: Monthly (to a maximum of 12 months)

  5. Progression Free Survival (PFS)

    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.

    Time frame: Monthly (to a maximum of 12 months)

  6. Overall Survival

    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.

    Time frame: Monthly (to a maximum of 12 months)

07

Study locations

5 sites
  • Desert Comprehensive Cancer Center
    Palm Springs, California 92262, United States
  • University of Colorado Cancer Center
    Aurora, Colorado 80045, United States
  • University of North Carolina
    Chapel Hill, North Carolina 27514, United States
  • Fox Chase Cancer Center
    Philadelphia, Pennsylvania 19111, United States
  • Vanderbilt Ingram Cancer Center
    Nashville, Tennessee 37232, United States
08

References and documents

Individual participant data

Plan to share: No — Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2010 to primary completion in Jan 2012, 23 months.

Of 44 industry-sponsored phase 1 interventional studies under Adenocarcinoma, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 45. This study's 23 months is below that.

Counting every sponsor, half of 111 studies reached it within 41 months; a quarter within 27 and three quarters within 58.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 6, 2009
First posted
Nov 10, 2009
StartActual
Feb 3, 2010
Primary completionActual
Jan 25, 2012
CompletionActual
Jan 25, 2012
Last update
Nov 21, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01010945
Lead sponsor
OSI Pharmaceuticals
Responsible party
Sponsor
First posted
Nov 10, 2009
Start date
Feb 3, 2010
Primary completion
Jan 25, 2012
Completion
Jan 25, 2012
Last update
Nov 21, 2024

Study contacts

Medical Monitor
study director · Astellas Pharma Global Development

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Erlotinib · Gemcitabine · Albumin-Bound Paclitaxel

Other studies in this condition

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