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Advanced Pancreatic CancerPhase 1NCT01010945

Erlotinib, Gemcitabine and Nab-Paclitaxel in Advanced Pancreatic Cancer

A Phase 1 study testing erlotinib, gemcitabine and nab-paclitaxel in people with Advanced Pancreatic Cancer, run by OSI Pharmaceuticals at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Pancreatic Cancer
What is being tested?
erlotinib, gemcitabine and nab-paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
5 sitesUnited States
Study dates
3 Feb 2010to 25 Jan 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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

Who cannot join

  • 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 locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • University of North Carolina

    Chapel Hill, North Carolina, 27514

  • Vanderbilt Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Desert Comprehensive Cancer Center

    Palm Springs, California, 92262

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

Other trials in United States

About this study

Official title: A Phase Ib Study of Erlotinib in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Previously Untreated Advanced Pancreatic Cancer

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.

Keywords
erlotinib, nab-paclitaxel, gemcitabine, Adenocarcinoma, Advanced Pancreatic Cancer, Phase 1b
Medical subject headings
Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01010945
Study groupRoleWhat they receive
erlotinib, gemcitabine, nab-paclitaxelExperimentalPatients 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.
Receives: Drug: erlotinib; Drug: gemcitabine; Drug: nab-paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerated Dose

    Measured: Monthly (to a maximum of 12 months)

Secondary outcomes (6)

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

    Measured: 1 month

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

    Measured: Monthly (to a maximum of 12 months)

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

    Measured: 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".

    Measured: 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.

    Measured: 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.

    Measured: Monthly (to a maximum of 12 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2009 (estimated)
  2. Study start3 Feb 2010
  3. Primary completion25 Jan 2012
  4. Study completion25 Jan 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01010945
Sponsor's protocol ID
OSI-774-108
Other IDs
09PAN01
Status last verified
Nov 2024
First submitted
6 Nov 2009
Last updated
21 Nov 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
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/.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing erlotinib, gemcitabine and nab-paclitaxel in people with Advanced Pancreatic Cancer, run by OSI Pharmaceuticals at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (time frame: Monthly (to a maximum of 12 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01010945.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.

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