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Pancreatic CancerPhase 2GEMOX-TNCT01505413

Phase 2 Study of Erlotinib, Gemcitabine and Oxaliplatin Combination Chemotherapy to Advanced Pancreatic Cancer

A Phase 2 study testing Erlotinib, Gemcitabine and Oxaliplatin in people with Pancreatic Cancer, run by Soonchunhyang University Hospital at 1 site in South Korea.

Completed

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

Official record
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Trial summary

Erlotinib is an orally available, reversible tyrosine kinase inhibitor of epidermal growth factor receptor (EGFR). Association of chemoresistance with the activity of certain tyrosine kinases (e.g. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
Erlotinib, Gemcitabine and Oxaliplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteSouth Korea
Study dates
Jan 2011to Mar 2014
Phase
Phase 2
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

  • Age over 18 years
  • ECOG performance status of ≤2
  • Histologically confirmed adenocarcinoma of the pancreas
  • The disease is Locally advanced deemed by the surgeon to be unresectable, or metastatic disease.
  • Prior chemotherapy is not permitted, except for fluorouracil given concurrently as a radiosensitizer.
  • Patients must have normal organ function evidenced by
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  • Number of absolute neutrophil counts (ANC) > 1.5 x 109/L
  • Number of thrombocytes > 100 x 109/L
  • Total bilirubin < 1.5 x upper limit of normal (although patients with a Total bilirubin count between 1.5 and 3 x upper limit of normal in whom a decrease is anticipated, ex. Biliary stent insertion)ALAT, ASAT < 3 x upper limit of normal (in case of liver metastasis, 5 x upper limit of normal)
  • Alkaline phosphatase < 3 x upper limit of normal (in case of liver metastasis, 5 x upper limit of normal)
  • Pain should be controlled for at least two weeks without an increase in the narcotic consumption.
  • Biliary obstruction should be controlled for at least two weeks evident by stable or improving liver function tests especially total bilirubin.
  • Patient has signed a Patient Informed Consent Form.
  • For all females of childbearing potential, a negative pregnancy test must be obtained within 72 hours before starting therapy.
  • Is able to take medications orally
  • A patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in spiral CT or multidetector CT (MD CT) or 20 mm or longer in conventional CT (it should be used by a consistent method during the study period)

Who cannot join

  • Tumor type other than adenocarcinoma
  • Evidence of uncontrolled CNS disease (patients with controlled CNS disease for 4 weeks using the same imaging method and for whom are off steroid will be eligible)
  • Uncontrolled Nausea and Vomiting
  • Diagnosis of other malignancy in the last 5 years excluding non-melanoma skin cancer and in -situ cervical cancer.
  • Subjects unlikely to comply with protocol, e.g. uncooperative attitude, inability to return for follow- up visits and unlikelihood of completing the study.
  • Any known history of hypersensitivity to the study drugs.
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  • Pregnant or lactating women.
  • Symptomatic peripheral sensory neuropathy (NCI CTCAE v3.0 ≥ grade 2)
  • Other serious illness or medical condition, notably heart or lung failure, active uncontrolled infection
  • Prior radiotherapy was administered to target lesions selected for this study, or radiotherapy to the non-target lesions has been completed within 4 weeks before being included in the study.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Soonchunhyang University Bucheon Hospital

    Bucheon-si, Gyeonggi-do, 420-767

Other trials in South Korea

About this study

Official title: Phase 2 Study of GEMOX-T in Previously Untreated Patients With Advanced Pancreatic Cancer

Erlotinib is an orally available, reversible tyrosine kinase inhibitor of epidermal growth factor receptor (EGFR). Association of chemoresistance with the activity of certain tyrosine kinases (e.g. ErbB-1 and Src) has been described for pancreatic cancer and makes a strong case for combining gemcitabine with tyrosine kinase inhibitors. In a phase III trial, the addition of erlotinib to gemcitabine improved survival compared with gemcitabine alone in advanced pancreatic cancer (MJ Moor et al). Also, gemcitabine in combination with oxaliplatin is superior to gemcitabine alone in terms of progression free survival and response rate in one phase III trial (Louvet et al). Taken together, combining erlotinib with gemcitabine and oxaliplatin may further improve the overall survival and clinical benefit of advanced pancreatic cancer.

Read the detailed description

Open, uncontrolled, multicenter, phase II study

This study will enroll previous chemo-naïve patients with locally advanced unresectable or metastatic pancreatic cancer.

Study regimen:

  • Erlotinib 100 mg po qd daily AND
  • Gemcitabine 1000 mg/m² with 150mL of normal saline intravenously infusion over 100min on Day 1
  • Oxaliplatin 100 mg/m2 with 500mL of 5DW intravenously a 2-hour infusion on D2 Every 2 weeks

Each two weeks is a cycle. If at end of 12 cycles response continues, will administer Gemcitabine and erlotinib until progression.

Keywords
advanced unresectable or metastatic Pancreatic Cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • ErlotinibDrug

    Also called tarceva

    Erlotinib 100 mg po qd daily

  • GemcitabineDrug

    Also called gemza, gemcibine

    Gemcitabine 1000 mg/m² with 150mL of normal saline intravenously infusion over 100min on Day 1

  • OxaliplatinDrug

    Also called oxalitin

    Oxaliplatin 100 mg/m2 with 500mL of 5DW intravenously a 2-hour infusion on D2

Study groups in NCT01505413
Study groupRoleWhat they receive
Tarceva, Gemcitabine, OxaliplatinExperimental* Erlotinib 100 mg po qd daily AND * Gemcitabine 1000 mg/m² with 150mL of normal saline intravenously infusion over 100min on Day 1 * Oxaliplatin 100 mg/m2 with 500mL of 5DW intravenously a 2-hour infusion on D2 Every 2 weeks Each two weeks is a cycle. If at end of 12 cycles response continues, will administer Gemcitabine and erlotinib until progression.
Receives: Drug: Erlotinib; Drug: Gemcitabine; Drug: Oxaliplatin

What is being measured

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

  1. Response rate

    Responses are assessed every 2 cycles according to RECIST; the imaging tests are performed in a week preceding the corresponding cycles, and can also be repeated at any other time if clinically indicated, for example, to confirm disease progression. At any time, patients with progressive disease are withdrawn.

    Measured: 24 months (01/2011 and end of study 01/2013)

Secondary outcomes (2)

  1. disease control rate(SD,PR,CR)

    Responses are assessed every 2 cycles according to RECIST; the imaging tests are performed in a week preceding the corresponding cycles, and can also be repeated at any other time if clinically indicated, for example, to confirm disease progression. At any time, patients with progressive disease are withdrawn.

    Measured: 24 months (01/2011 and end of study 01/2013)

  2. Overall survival

    Measured: 1 year

Timeline

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

  1. First posted6 Jan 2012 (estimated)
  2. Study startJan 2011
  3. Primary completionDec 2013
  4. Study completionMar 2014

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01505413
Sponsor's protocol ID
Yun-11349
Acronym
GEMOX-T
Status last verified
Apr 2014
First submitted
2 Jan 2012
Last updated
3 Apr 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Erlotinib, Gemcitabine and Oxaliplatin in people with Pancreatic Cancer, run by Soonchunhyang University Hospital at 1 site in South Korea.

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 16 inclusion and 10 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 3 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Response rate (time frame: 24 months (01/2011 and end of study 01/2013)). 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 NCT01505413.

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 3 Apr 2014.

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