Skip to content
Triangle logo TriangleGet started
← Study library

NCT00634725 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2015-12-11

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the pancreas meeting the following criteria: * De novo locally advanced disease * Unresectable disease * Stage III according to the UICC classification * No distant metastases * No localized stage IA-IIB or metastatic stage IV disease according to UICC classification * Not considered for curative resection after pluridisciplinary discussion PATIENT CHARACTERISTICS: Inclusion criteria: * 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) * 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 Exclusion criteria: * 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 * 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
healthy Volunteers
false
maximum Age
120 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Gemcitabine 2 months, then stop until progression
    intervention Names
    1. Drug: gemcitabine hydrochloride
    2. Other: laboratory biomarker analysis
    label
    Arm 1 (A1) - Gemcitabine
    type
    ACTIVE_COMPARATOR
  2. description
    B1 Gemcitabine + Erlotinib (100mg/d) 2 months, then erlotinib maintenance (150 mg/d)until progression
    intervention Names
    1. Drug: erlotinib hydrochloride
    2. Drug: gemcitabine hydrochloride
    3. Other: laboratory biomarker analysis
    label
    Arm 2 (B1) Gemcitabine + Erlotinib
    type
    EXPERIMENTAL
  3. description
    A2 CRT then stop until progression
    intervention Names
    1. Drug: capecitabine
    2. Other: laboratory biomarker analysis
    3. Radiation: radiation therapy
    label
    Arm 3 (A2) CRT
    type
    EXPERIMENTAL
  4. description
    B2 CRT then erlotinib maintenance (150mg/d) until progression
    intervention Names
    1. Drug: capecitabine
    2. Drug: erlotinib hydrochloride
    3. Other: laboratory biomarker analysis
    4. Radiation: radiation therapy
    label
    Arm 4 (B2) CRT then erlotinib
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm 3 (A2) CRT
    2. Arm 4 (B2) CRT then erlotinib
    name
    capecitabine
    type
    DRUG
  2. arm Group Labels
    1. Arm 2 (B1) Gemcitabine + Erlotinib
    2. Arm 4 (B2) CRT then erlotinib
    name
    erlotinib hydrochloride
    type
    DRUG
  3. arm Group Labels
    1. Arm 1 (A1) - Gemcitabine
    2. Arm 2 (B1) Gemcitabine + Erlotinib
    name
    gemcitabine hydrochloride
    type
    DRUG
  4. arm Group Labels
    1. Arm 1 (A1) - Gemcitabine
    2. Arm 2 (B1) Gemcitabine + Erlotinib
    3. Arm 3 (A2) CRT
    4. Arm 4 (B2) CRT then erlotinib
    name
    laboratory biomarker analysis
    type
    OTHER
  5. arm Group Labels
    1. Arm 3 (A2) CRT
    2. Arm 4 (B2) CRT then erlotinib
    name
    radiation therapy
    type
    RADIATION
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
820
type
ESTIMATED
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    an interim analysis is planned when 196 deaths will be observed
    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
secondary Outcomes
  1. measure
    Progression-free survival
    time Frame
    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. description
    1 biopsy/patient of the pancreas before treatment
    measure
    Relationship between biological markers and survival
    time Frame
    From baseline to death, assessed up to 8 years after the beginning of the study
  3. description
    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.
    measure
    tolerance to erlotinib
    time Frame
    from start of treatment until the event has resolved or stabilized or until death
Full study description
brief 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. 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.
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.
Source references
references
  1. citation
    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.
    pmid
    27139057
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-7ad944f6deaf1f5cd6122126
      edge id
      nct-edge-990c5a514c2790db0b53
      requested nct id
      NCT00634725
      primary nct id
      NCT00634725
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source file sha256
      8177f7bf88aa9904df041d3c053471c18be378caa5a2506e765996c669b548b5
      payload sha256
      8f9ad8334a7ad8091502c57421e832f6fc02c0a8da11ce369b031af01f5e2cb4
      payload
      clinical indication matching status
      not_inferred
      end exclusive
      true
      id
      nct-edge-990c5a514c2790db0b53
      link basis
      explicit_NCT_identifier_in_acquired_source
      nct id
      NCT00634725
      occurrences
      1. context exact
        ged to chemotherapy followed by chemoradiation in the absence of metastases.</p> <div class="pdq-content-list"><ol id="_211"><li><a href="/clinicaltrials/NCT00634725">LAP07</a> (NCT00634725): The LAP07 study was an international, randomized, phase III study based on the results of the Groupe Coop&#233;rateur Multidisciplin
        end
        124452
        exact text
        NCT00634725
        start
        124441
      2. context exact
        owed by chemoradiation in the absence of metastases.</p> <div class="pdq-content-list"><ol id="_211"><li><a href="/clinicaltrials/NCT00634725">LAP07</a> (NCT00634725): The LAP07 study was an international, randomized, phase III study based on the results of the Groupe Coop&#233;rateur Multidisciplinaire en Oncologie (GERCO
        end
        124476
        exact text
        NCT00634725
        start
        124465
      offset unit
      unicode_code_points
      source file
      /tmp/cancer-full-research/nci/raw/c64e39c6020738af5c.html
      source file sha256
      8177f7bf88aa9904df041d3c053471c18be378caa5a2506e765996c669b548b5
      source json pointer
      Source null
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source retrieved at
      2026-09-09T23:22:11.084713+00:00
      source string basis
      UTF-8_text_with_universal_newline_translation
      source string sha256
      f17b4362661a50979f7d720e23c201ed0288f92f13bd3beacbe3167a2c7e5b69
      source title
      Pancreatic Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: February 12, 2025
        datetime
        2025-02-12T12:00:00Z
        display
        February 12, 2025

    Preserved source evidence · Not medical advice