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Pancreatic AdenocarcinomaPhase 2GEMCAD1003NCT01389440

Efficacy and Safety of a Neoadjuvant Treatment in Pancreatic Cancer

A Phase 2 study testing Gemcitabine and Erlotinib in people with Pancreatic Adenocarcinoma, run by Grupo Espanol Multidisciplinario del Cancer Digestivo at 10 sites in Spain.

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

This is a Phase II open study, not randomized with a neoadjuvant therapy,combination of Gemcitabine (1,000 mg/m2/week) with Erlotinib (100mg/day) (3 cycles of 4 weeks), followed by gemcitabine (300 mg/m2/week) combined with Erlotinib (100mg/day) and radiotherapy (45 Gy / day fr180 cGy) (5 cycles of 1 week) in patients… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pancreatic Adenocarcinoma
What is being tested?
Gemcitabine and Erlotinib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
10 sitesSpain
Study dates
May 2011to 22 Jan 2017
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able to sign the inform consent form
  • Age between 18-75 years
  • Subject has not undergone any chemotherapy or radiotherapy previously
  • Functional status o-1 (ECOG scale)
  • Satisfy all radiological inclusion criteria (MSCT performed 28 days before the treatment starts and a centralized evaluation)
  • Patients with a cytologically confirmed diagnosis of pancreatic adenocarcinoma(preferably by EUS)
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  • Appropriate analytical as inclusion criteria (7 days before the treatment starts):
  • bone marrow status: neutrophils ≥ 1,500x10^9/L; platelets ≥ 100x10^9/L; hemoglobin ≥ 9g/dL.
  • INR ≤ 1.5 and PTT ≤ 1.5 x upper range of normal.
  • Bilirubin ≤ 5 mg/dL
  • Albumin> 34 g/L
  • Renal function: creatinine ≤ 1.5 mg/dL and creatinine clearance> 50ml/min

Who cannot join

  • patients treated with any of the study's drugs
  • patients who has develop other primary tumors in 5 years prior to the inclusion at the clinical trial, except for cervix carcinoma in situ or basal cell skin cancer which have been treated properly.
  • significant clinical cardiovascular disease: stroke (≤ 6 months before the study inclusion), heart attack (≤ 6 months before inclusion), unstable ango pectoris, congestive heart failure second grade or higher of the New York Heart Association (NYHA) or serious cardiac arrhythmia requiring medication, uncontrolled hypertension
  • Total o partial bowel obstruction
  • Chronic diarrhea
  • Current treatment with another investigational drug or participation in another clinical trial within 30 days prior to inclusion.
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  • Known hypersensitivity to any of the study drugs or their components
  • Currently o recent therapeutic treatment (opposite to prophylactic) with oral or parenteral anticoagulants (full dose) or thrombolytic agents. Patients who receive (or are candidates to receive) anticoagulants for prophylaxis of cardiovascular risk, should continue (or begin) treatment at baseline
  • Thromboembolic event history or bleeding in the 6 months prior to treatment.
  • Evidence of bleeding diathesis or coagulopathy.
  • Serious problems in wounds healing, ulcers or bone fractures.
  • Major surgery, open biopsy or significant traumatic injury 28 days before treatment.
  • Any other disease, metabolic disorder, physical examination findings or clinical laboratory that provides reasonable evidence for suspecting a disease or condition for which it is contraindicated or patient an experimental drug at high risk of experiencing complications related to treatment .
  • Patients undergoing with organ allografts requiring immunosuppressive treatment.
  • Pregnant or breastfeeding woman. It requires a negative pregnancy test (serum or urine) within 7 days before previous to treatment.
  • Men and women of childbearing potential (including women who have had their last menstrual period in less than 2 years) not using effective contraception precautions
  • Positive HIV status
  • Addiction to alcohol or other drugs
  • Known liver cirrhosis

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Spain10 sites

  • Hospital del Mar

    Barcelona, 08003

  • Institut Català d'Oncologia (ICO) de L'Hospitalet

    Barcelona, 08007

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital Clínic de Barcelona

    Barcelona, 08036

  • Hospital Santa Creu y Sant Pau, Hospital Sant Pau

    Barcelona, 08041

  • Instituto Catalán de Oncología

    Girona, 17007

  • Hospital Virgen de la Arrixaca

    Murcia, 30120

  • Clínica Universitaria de Navarra

    Pamplona, Navarre, 31008

  • Hospital la Fe de Valencia

    Valencia, 46009

  • Clínico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

About this study

Official title: Phase II Study Open, Not Randomized to Evaluate the Efficacy and Safety of Neoadjuvant Treatment With Gemcitabine and Erlotinib Followed by Gemcitabine, Erlotinib and Radiotherapy in Patients With Resectable Pancreatic Adenocarcinoma

This is a Phase II open study, not randomized with a neoadjuvant therapy,combination of Gemcitabine (1,000 mg/m2/week) with Erlotinib (100mg/day) (3 cycles of 4 weeks), followed by gemcitabine (300 mg/m2/week) combined with Erlotinib (100mg/day) and radiotherapy (45 Gy / day fr180 cGy) (5 cycles of 1 week) in patients with resectable pancreatic adenocarcinoma to assess the percentage of R0 resections. They have planned a total of 21 visits.

Being tested
Gemcitabine and Erlotinib
Keywords
Resectable pancreatic adenocarcinoma, Gemcitabine, Erlotinib, Radiotherapy, Neoadjuvant treatment

What participants receive

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

  • Gemcitabine and ErlotinibDrug

    Also called Gemcitabine and Tarceva

    Administration of gemcitabine (300mg/m2/weekly)with Erlotinib (100 mg/daily) and radiotherapy (45 Gy/daily) after a period of infusion with a full dose of Gemcitabine (1.000mg/m2/weekly) and Erlotinib (100 mg/daily)

Study groups in NCT01389440
Study groupRoleWhat they receive
Gemcitabine, Erlotinib and radiotherapyExperimentalGemcitabine + Erlotinib follow by Gemcitabine + Erlotinib + radiotherapy
Receives: Drug: Gemcitabine and Erlotinib

What is being measured

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

  1. Percentage of ancients undergoing with neoadjuvant chemoradiotherapy and R0 resection

    Measured: 3 years

Secondary outcomes (9)

  1. To describe the safety of the treatment

    Based in safety population, all safety parameters will be analyzed and they will be recorded in lists and spread sheets. Most extreme intensity will be used for the notification of adverse events.

    Safety population will include all subjects that have taken at least one study medication dose.

    Measured: 3 years

  2. Evaluate the response rate using RECIST criteria

    Measured: 3 years

  3. Evaluate the percentage of resectability

    Measured: 3 years

  4. Evaluate the percentage of lymphatic nodes removed

    Measured: 3 years

  5. Evaluate the percentage of lymphatic nodes involved

    Measured: 3 years

  6. Evaluate the pathological regression stage (primary tumor and lymphatic nodes)

    Measured: 3 years

  7. Relate RECIST criteria with the pathological regress stage

    Measured: 3 years

  8. Measure the progression free survival (time from the inclusion date to the progression of the disease or death)

    Measured: 3 years

  9. Evaluate the overall survival time

    Measured: 3 years

Timeline

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

  1. First posted8 Jul 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionNov 2016
  4. Study completion22 Jan 2017

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
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01389440
Sponsor's protocol ID
GEMCAD1003
Other IDs
2010-021738-72
Acronym
GEMCAD1003
Status last verified
Aug 2017
First submitted
1 Jul 2011
Last updated
18 May 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Maurel J, Sanchez-Cabus S, Laquente B, Gaba L, Visa L, Fabregat J, Poves I, Rosello S, Diaz-Beveridge R, Martin-Richard M, Rodriguez J, Sabater L, Conill C, Cambray M, Reig A, Ayuso JR, Valls C, Ferrandez A, Bombi JA, Gines A, Garcia-Albeniz X, Fernandez-Cruz L. Outcomes after neoadjuvant treatment with gemcitabine and erlotinib followed by gemcitabine-erlotinib and radiotherapy for resectable pancreatic cancer (GEMCAD 10-03 trial). Cancer Chemother Pharmacol. 2018 Dec;82(6):935-943. doi: 10.1007/s00280-018-3682-9. Epub 2018 Sep 17.

    PubMed 30225601

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gemcitabine and Erlotinib in people with Pancreatic Adenocarcinoma, run by Grupo Espanol Multidisciplinario del Cancer Digestivo at 10 sites in Spain.

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 12 inclusion and 19 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 18 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Spain. 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?

Percentage of ancients undergoing with neoadjuvant chemoradiotherapy and R0 resection (time frame: 3 years). 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 NCT01389440, which also lists 1 linked publication.

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 18 May 2018.

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