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Pancreatic CancerPhase 3NCT00634725

Gemcitabine With or Without Capecitabine and/or Radiation Therapy or Gemcitabine With or Without Erlotinib in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed by Surgery

A Phase 3 study testing capecitabine, erlotinib hydrochloride and gemcitabine hydrochloride in people with Pancreatic Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 72 sites in France.

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

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Pancreatic Cancer
What is being tested?
capecitabine, erlotinib hydrochloride and gemcitabine hydrochloride
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
820 participants
Where
72 sitesFrance
Study dates
Feb 2008to Sep 2014
Phase
Phase 3
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 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ECOG performance status 0-2
  • Life expectancy ≥ 12 weeks
  • Polynuclear neutrophils ≥ 1.5 x 10^9/L
  • Platelets ≥ 100 x 10^9/L
  • Hemoglobin ≥ 9 g/dL
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
Show all 14Show fewer
  • For patients who have had a recent biliary drain and whose bilirubin is descending, a value of ≤ 3 times ULN is acceptable
  • Creatinine ≤ 2 mg/dL
  • AST and ALT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 5 times ULN
  • Albumin ≥ 25 g/L
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of therapy

Who cannot join

  • Diarrhea ≥ grade 2 and/or uncontrolled diarrhea
  • Affiliated with a social security regime
  • Unable to follow instructions for psychological, familial, or geographical reasons
  • Allergic to one of the ingredients in erlotinib hydrochloride
  • Cancer within the past 5 years, except for in situ cancer of the neck of the uterus or basal cell skin cancer
  • Severe infection
Show all 14Show fewer
  • Ophthalmic disease (i.e., inflammation, keratopathy, or infection)
  • Symptomatic coronary or cardiac insufficiency, myocardial infarction, or stroke within the last 6 months
  • Unable to take oral treatments
  • Gastrointestinal disorders that could be associated with absorption disorders
  • Untreated gastric or duodenal ulcer
  • PRIOR CONCURRENT THERAPY:
  • No prior radiotherapy (including abdominal radiotherapy) or chemotherapy for any reason
  • No prior anti-epidermal growth factor-receptor therapy

Trial locations and contacts

72 sites in 1 country.

72 sites in 1 country

France72 sites

  • Centre Radiotherapie Oncologie Moyenne Garonne

    Agen, 47000

  • Centre Hospitalier d'Aix en Provence

    Aix-en-Provence, 13616

  • Centre Paul Papin

    Angers, 49036

  • Polyclinique Sainte Marguerite

    Auxerre, 89000

  • Centre Hospitalier d'Auxerre

    Auxerre, 89011

  • Institut Sainte Catherine

    Avignon, 84000

  • Hopital Duffaut

    Avignon, 84902

  • Centre Hospitalier de la Cote Basque

    Bayonne, 64100

  • Centre Hospitalier de Beauvais

    Beauvais, 72037

  • Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

    Besançon, 25030

  • Hopital de Beziers

    Béziers, 34525

  • Hopital Saint Andre

    Bordeaux, 33075

  • Institut Bergonie

    Bordeaux, 33076

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33300

  • Clinique Tivoli

    Bordeaux, F-33000

  • Hopital Ambroise Pare

    Boulogne-Billancourt, F-92104

  • Centre Hospitalier Pierre Oudot

    Bourgoin, 38300

  • CHU de Caen

    Caen, 14033

  • Polyclinique Du Parc

    Caen, 14052

  • Hopital Beaujon

    Clichy, 92110

  • Hopital Louis Pasteur

    Colmar, 68024

  • Centre Hospitalier Compiegne

    Compiègne, 60321

  • Centre Hospitalier Universitaire Henri Mondor

    Créteil, 94000

  • Centre Hospitalier de Dax

    Dax, 40100

  • Centre Hospitalier de Digne les Bains

    Digne-les-Bains, 04003

  • Hopital Du Bocage

    Dijon, 21034

  • Centre de Lutte Contre le Cancer Georges-Francois Leclerc

    Dijon, 21079

  • Centre Hospitalier Draguignan

    Draguignan, 83300

  • CHU de Grenoble - Hopital de la Tronche

    Grenoble, 38043

  • Centre Hospitalier Departemental

    La Roche-sur-Yon, F-85025

  • Centre Hospitalier de Lagny

    Lagny-sur-Marne, 77405

  • Hopital Louis Pasteur - Le Coudray

    Le Coudray, 28630

  • Centre Hospitalier Universitaire de Bicetre

    Le Kremlin-Bicêtre, 94275

  • Clinique Victor Hugo

    Le Mans, F-72000

  • Hopital Robert Boulin

    Libourne, 33500

  • Polyclinique Du Bois

    Lille, 59000

  • Polyclinique des Quatre Pavillons

    Lormont, 33310

  • Centre Hospitalier St. Joseph St. Luc

    Lyon, 69007

  • Hopital Prive Jean Mermoz

    Lyon, 69008

  • Hopital de la Croix Rousse

    Lyon, 69317

  • Centre Leon Berard

    Lyon, 69373

  • Hopital Edouard Herriot - Lyon

    Lyon, 69437

  • Centre Hospitalier Chanaux

    Mâcon, 71018

  • Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

    Marseille, 13273

  • CHU de la Timone

    Marseille, 13385

  • Centre Gray

    Maubeuge, 59600

  • Centre Hospitalier de Meaux

    Meaux, 77104

  • Centre Hospitalier General de Mont de Marsan

    Mont-de-Marsan, 40000

  • Centre Hospitalier de Montelimar

    Montélimar, 26200

  • C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau

    Nîmes, 30029

  • Clinique De Valdegour

    Nîmes, 30900

  • CHR D'Orleans - Hopital de la Source

    Orléans, 45067

  • Hopital Pitie-Salpetriere

    Paris, 75013

  • Hopital Europeen Georges Pompidou

    Paris, 75015

  • Hopital Bichat - Claude Bernard

    Paris, 75018

  • Hopital Saint-Louis

    Paris, 75475

  • Hopital Saint Antoine

    Paris, 75571

  • Hopital Saint Joseph

    Paris, 75674

  • Hopital Tenon

    Paris, 75970

  • Centre Catalan d'Oncologie

    Perpignan, 66000

  • Hopital Haut Leveque

    Pessac, 33604

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • CHU Poitiers

    Poitiers, 86021

  • Hopital Rene Dubos

    Pontoise, 95300

  • CHU - Robert Debre

    Reims, 51092

  • Hopital Charles Nicolle

    Rouen, 76031

  • Centre Hospitalier

    Saint-Omer, 62505

  • Centre Hospitalier de Tarbes

    Tarbes, 65013

  • Centre Hospitalier Regional Metz Thionville

    Thionville, 57126

  • CHRU de Tours - Hopital Trousseau

    Tours, 37000

  • Nouvelle Clinique Generale

    Valence, 26000

  • Centre Hospitalier Bretagne Atlantique

    Vannes, 56016

Other trials in France

About this study

Official title: Randomized Multicenter Phase III Study in Patients With Locally Advanced Adenocarcinoma of the Pancreas: Gemcitabine With or Without Chemoradiotherapy and With or Without Erlotinib. Intergroup Study

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which regimen of chemotherapy with or without erlotinib and/or radiation therapy is most effective in treating pancreatic cancer.

PURPOSE: This randomized phase III trial is studying giving gemcitabine together with or without capecitabine and/or radiation therapy to see how well it works compared with giving gemcitabine together with or without erlotinib in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.

Read the detailed description

OBJECTIVES:

Primary

  • To assess whether administrating chemoradiotherapy in patients whose tumor is controlled after 4 months of induction chemotherapy (CT) increases survival compared with continuation of the same CT in patients with unresectable, locally advanced adenocarcinoma of the pancreas.

Secondary

  • To assess whether erlotinib hydrochloride combined with gemcitabine hydrochloride and administered as maintenance treatment increases progression-free survival compared with gemcitabine hydrochloride alone and without maintenance treatment.
  • To evaluate the response rate in the CT and chemoradiotherapy (CRT) arms.
  • To evaluate tolerance to erlotinib hydrochloride as maintenance treatment after the end of CT or CRT.
  • To study the predictive molecular factors (i.e., survivin, K-ras, EGFR, PTEN, or AKT) of survival.

OUTLINE: This is a multicenter study. Patients in the first randomization are stratified according to center and ECOG performance status (0-1 vs 2). Patients in the second randomization are stratified according to center and initial treatment arm (I vs II).

  • First randomization: Patients are randomized to 1 of 2 treatment arms.
  • Arm I: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43. Following the first evaluation, patients continue to receive gemcitabine hydrochloride on days 57, 64, 71, 85, 92, and 99 for a total of 4 months.
  • Arm II: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43. Following the first evaluation, patients continue to receive gemcitabine hydrochloride on days 57, 64, 71, 85, 92, and 99. Patients also receive oral erlotinib hydrochloride once daily for 4 months.

After completion of treatment in the first randomization proceed to the second randomization.

  • Second randomization: Patients are randomized to 1 of 4 treatment arms.
  • Arm I: Patients continue gemcitabine hydrochloride as in arm I in the first randomization on days 113, 120, and 127 and on days 141, 148, and 155 for 2 months in the absence of disease progression.
  • Arm II: Patients continue gemcitabine hydrochloride as in arm II in the first randomization on days 113, 120, and 127 and on days 141, 148, and 155 and oral erlotinib hydrochloride daily for 2 months followed by erlotinib hydrochloride alone as maintenance therapy in the absence of disease progression.
  • Arm III: Patients receive oral capecitabine twice daily and undergo radiotherapy beginning on day 127, 5 days a week, for 6 weeks, in the absence of disease progression.
  • Arm IV: Patients receive oral capecitabine twice daily and undergo radiotherapy beginning on day 127, 5 days a week, for 6 weeks. Beginning 15 days after completion of CRT, patients receive a reintroduction of oral erlotinib hydrochloride alone once daily in the absence of disease progression or unacceptable toxicity.

Tumor tissue will be analyzed for the relationship between biological markers and resistance to treatment.

After completion of study treatment, patients are followed every 2 months.

Being tested
capecitabine, erlotinib hydrochloride, gemcitabine hydrochloride, laboratory biomarker analysis, radiation therapy
Keywords
adenocarcinoma of the pancreas, stage III 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.

Study groups in NCT00634725
Study groupRoleWhat they receive
Arm 1 (A1) - GemcitabineActive comparatorGemcitabine 2 months, then stop until progression
Receives: Drug: gemcitabine hydrochloride; Other: laboratory biomarker analysis
Arm 2 (B1) Gemcitabine + ErlotinibExperimentalB1 Gemcitabine + Erlotinib (100mg/d) 2 months, then erlotinib maintenance (150 mg/d)until progression
Receives: Drug: erlotinib hydrochloride; Drug: gemcitabine hydrochloride; Other: laboratory biomarker analysis
Arm 3 (A2) CRTExperimentalA2 CRT then stop until progression
Receives: Drug: capecitabine; Other: laboratory biomarker analysis; Radiation: radiation therapy
Arm 4 (B2) CRT then erlotinibExperimentalB2 CRT then erlotinib maintenance (150mg/d) until progression
Receives: Drug: capecitabine; Drug: erlotinib hydrochloride; Other: laboratory biomarker analysis; Radiation: radiation therapy

What is being measured

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

  1. Overall survival

    an interim analysis is planned when 196 deaths will be observed

    Measured: from the date of the first randomization to the date of patient death,due to any cause, or to the last date the patient was known to be alive, assessed up to 8 years after the beginning of the study

Secondary outcomes (3)

  1. Progression-free survival

    Measured: time from the date of the first randomization to the date of progressive disease or death, assessed up to 8 years after the beginning of the study.

  2. Relationship between biological markers and survival

    1 biopsy/patient of the pancreas before treatment

    Measured: From baseline to death, assessed up to 8 years after the beginning of the study

  3. tolerance to erlotinib

    To evaluate tolerance to erlotinib as maintenance treatment after the end of CT or CRT.

    During each visit, any adverse events will be noted and graded according to version 3 of the NCI-CTCAE. Any adverse events that persist at the end of the CTI will be followed up until they disappear.

    Measured: from start of treatment until the event has resolved or stabilized or until death

Timeline

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

  1. First posted13 Mar 2008 (estimated)
  2. Study startFeb 2008
  3. Primary completionFeb 2013
  4. Study completionSep 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
820 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00634725
Sponsor's protocol ID
CDR0000589283
Other IDs
GERCOR-LAP-07-D07-1, EU=20827, ROCHE-GERCOR-LAP-07-D07-1, EudraCT- 2007-001174-81
Status last verified
Nov 2012
First submitted
12 Mar 2008
Last updated
11 Dec 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Hammel P, Huguet F, van Laethem JL, Goldstein D, Glimelius B, Artru P, Borbath I, Bouche O, Shannon J, Andre T, Mineur L, Chibaudel B, Bonnetain F, Louvet C; LAP07 Trial Group. Effect of Chemoradiotherapy vs Chemotherapy on Survival in Patients With Locally Advanced Pancreatic Cancer Controlled After 4 Months of Gemcitabine With or Without Erlotinib: The LAP07 Randomized Clinical Trial. JAMA. 2016 May 3;315(17):1844-53. doi: 10.1001/jama.2016.4324.

    PubMed 27139057

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing capecitabine, erlotinib hydrochloride and gemcitabine hydrochloride in people with Pancreatic Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 72 sites in France.

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 14 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 11 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Overall survival (time frame: from the date of the first randomization to the date of patient death,due to any cause, or to the last date the patient was known to be alive, assessed up to 8 years after the beginning of the study). 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 NCT00634725, 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 11 Dec 2015.

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