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Gemcitabine and Erlotinib Before and After Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery

4 października 2019 zaktualizowane przez: Alliance for Clinical Trials in Oncology

A Phase II Study of Preoperative Gemcitabine and Erlotinib Plus Pancreatectomy and Postoperative Gemcitabine and Erlotinib for Patients With Operable Pancreatic Adenocarcinoma

PURPOSE: This phase II trial is studying how well gemcitabine and erlotinib work when given before and after surgery in treating patients with pancreatic cancer that can be removed by surgery. Drugs used in chemotherapy, such as gemcitabine, 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. Giving gemcitabine and erlotinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these drugs after surgery may kill any tumor cells that remain after surgery.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

This is a single arm, non-randomized phase II study. Eligible, fully registered patients will receive preoperative chemotherapy consisting of gemcitabine plus erlotinib. Preoperative chemotherapy will be followed by exploratory laparotomy and pancreaticoduodenectomy. Patients will then receive postoperative chemotherapy consisting of gemcitabine plus erlotinib. Up to 123 patients will be accrued to this study, with the expectation that 78 patients will remain fully eligible and evaluable for the primary endpoint. The primary and secondary objectives for the study are listed below.

Primary Objective:

To estimate the proportion of patients alive at two years from the date of registration

Secondary Objectives:

  1. To determine the resection rate (defined as the fraction of patients who proceed to planned surgery with removal of primary tumor [R0/R1]) following induction treatment with gemcitabine plus erlotinib
  2. To estimate the time to disease progression/relapse
  3. To evaluate the rate of R0, R1, and R2 resections (defined as per the 6th edition of the AJCC Cancer Staging Manual) in patients treated with preoperative gemcitabine plus erlotinib chemotherapy
  4. To evaluate the toxicity profile of preoperative gemcitabine plus erlotinib and the feasibility of postoperative gemcitabine plus erlotinib
  5. To evaluate response rates to preoperative chemotherapy for patients treated with preoperative gemcitabine and erlotinib
  6. To identify molecular predictors of pancreatic cancer response to gemcitabine combined with erlotinib
  7. To identify genetic profiles of pancreatic adenocarcinoma that may be associated with response to neoadjuvant therapy

After completion of postoperative chemotherapy treatment, patients are followed every 3 months for 2 years and then every 6 months for 2 years.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

123

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Kanada
    • Ontario
      • Toronto, Ontario, Kanada, M5G 2M9
        • Princess Margaret Hospital
  • Stany Zjednoczone
    • California
      • La Jolla, California, Stany Zjednoczone, 92093-0658
        • Rebecca and John Moores UCSD Cancer Center
      • Los Angeles, California, Stany Zjednoczone, 90027
        • Kaiser Permanente Medical Center - Los Angeles
      • Orange, California, Stany Zjednoczone, 92868
        • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
    • Connecticut
      • Bridgeport, Connecticut, Stany Zjednoczone, 06606
        • St. Vincent's Medical Center
    • Florida
      • Lakeland, Florida, Stany Zjednoczone, 33805
        • Lakeland Regional Cancer Center at Lakeland Regional Medical Center
    • Indiana
      • Indianapolis, Indiana, Stany Zjednoczone, 46237
        • St. Francis Hospital Cancer Care Services
    • Maryland
      • Baltimore, Maryland, Stany Zjednoczone, 21229
        • St. Agnes Hospital Cancer Center
      • Baltimore, Maryland, Stany Zjednoczone, 21215
        • Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
    • Mississippi
      • Jackson, Mississippi, Stany Zjednoczone, 39216
        • University of Mississippi Cancer Clinic
    • Nebraska
      • Omaha, Nebraska, Stany Zjednoczone, 68114
        • Methodist Estabrook Cancer Center
    • New York
      • New York, New York, Stany Zjednoczone, 10016
        • NYU Cancer Institute at New York University Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, Stany Zjednoczone, 27599-7295
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
    • Ohio
      • Dayton, Ohio, Stany Zjednoczone, 45409
        • David L. Rike Cancer Center at Miami Valley Hospital
      • Dayton, Ohio, Stany Zjednoczone, 45415
        • Samaritan North Cancer Care Center
      • Dayton, Ohio, Stany Zjednoczone, 45420
        • CCOP - Dayton
      • Kettering, Ohio, Stany Zjednoczone, 45429
        • Charles F. Kettering Memorial Hospital
      • Troy, Ohio, Stany Zjednoczone, 45373-1300
        • UVMC Cancer Care Center at Upper Valley Medical Center
    • Oklahoma
      • Tulsa, Oklahoma, Stany Zjednoczone, 74136
        • Natalie Warren Bryant Cancer Center at St. Francis Hospital
    • Oregon
      • Portland, Oregon, Stany Zjednoczone, 97213-2967
        • Providence Cancer Center at Providence Portland Medical Center
    • South Carolina
      • Spartanburg, South Carolina, Stany Zjednoczone, 29303
        • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
    • Virginia
      • Newport News, Virginia, Stany Zjednoczone, 23606
        • Surgical Oncology Associates
    • West Virginia
      • Morgantown, West Virginia, Stany Zjednoczone, 26506
        • Mary Babb Randolph Cancer Center at West Virginia University Hospitals
    • Wisconsin
      • Madison, Wisconsin, Stany Zjednoczone, 53792-6164
        • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Eligibility Criteria:

  1. Cytologic or histologic proof of adenocarcinoma of the pancreatic head or uncinate process.

    NOTE: Patients with tumors of the pancreatic neck, body or tail are not eligible. Patients with evidence of neuroendocrine tumors, duodenal adenocarcinoma, or ampullary adenocarcinoma are not eligible.

  2. Localized, potentially resectable tumors as defined below. All patients must be staged with a chest X-ray or CT, and abdominal CT (contrast-enhanced, helical thin-cut) or MRI. Radiological resectability is defined by the following criteria on abdominal imaging:

    • No evidence of tumor extension to the celiac axis, hepatic artery, or superior mesenteric artery
    • No evidence of tumor encasement or occlusion of the superior mesenteric vein (SMV) or the SMV/portal vein confluence
    • No evidence of visceral or peritoneal metastases

    NOTE: Patients with borderline resectable or marginally resectable pancreatic cancer are not eligible. Patients must meet all objective imaging criteria outlined above.

  3. ≥ 18 years of age
  4. ECOG/Zubrod performance status of 0 or 1
  5. Baseline weight loss ≤ 15% of premorbid weight

  6. Patient must have adequate hematologic, renal, and hepatic function as defined by:

    • WBC ≥ 2,000 cells/mm³
    • ANC ≥ 1,500 cells/mm³
    • Platelets ≥ 100,000 cells/mm³
    • Serum bilirubin ≤ 2.5 mg/dL
    • Serum creatinine ≤ 1.5 mg/dL or a calculated creatinine clearance of ≥ 50 ml/min (24 hour urine collection)
    • ALT < 2.5 times upper limit of normal (ULN)
    • AST < 2.5 times ULN
    • Albumin ≥ 3.2 g/dl

  7. No history of the following:

    • Prior EGFR targeted therapy or therapy for pancreatic cancer
    • Active infection requiring intravenous antibiotics at the time of registration
  8. Non-pregnant and non-breast feeding. Female participants of child bearing potential must have a negative urine or serum pregnancy test prior to registration. Perimenopausal participants must be amenorrheic ≥ 12 months to be considered not of childbearing potential. All patients of reproductive potential must agree to use an effective method of birth control while receiving study therapy.
  9. No prior malignancy within 5 years of registration (Exceptions: non-melanoma skin cancer, in-situ cancers)

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Neoadjuvant therapy + Surgery + Adjuvant therapy
As part of neoadjuvant therapy, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 29, 36, and 43 and oral erlotinib hydrochloride once daily on days 1-43 in the absence of disease progression or unacceptable toxicity. Within 3-6 weeks after completion of neoadjuvant therapy, patients undergo pancreaticoduodenectomy and patients receive gemcitabine hydrochloride and erlotinib hydrochloride as in neoadjuvant therapy within 5-10 weeks post surgery.
Procedura: terapeutyczna chirurgia konwencjonalna
Lek: erlotinib hydrochloride
oral administration
Lek: gemcitabine hydrochloride
Intravenous administration

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Overall Survival at 2 Years
Ramy czasowe: At 2 years post-registration
The primary endpoint of this trial is 2-year overall survival, which will be evaluated as the proportion of treatment successes. A treatment success is defined to be an evaluable patient who is alive at two years from the date of registration.
At 2 years post-registration

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Resection Rate
Ramy czasowe: Up to 4 years postoperative chemotherapy treatment

The resection rate is defined as the fraction of patients that proceed to planned surgery with removal of primary tumor (R0/R1) following neoadjuvant treatment with gemcitabine plus erlotinib.The resection rate will be estimated by the binomial point estimate, i.e. as the number of patients that undergo the planned surgery with removal of the primary tumor following neoadjuvant treatment with gemcitabine plus erlotinib divided by the number of evaluable patients. This quantity will also be estimated with a 95% binomial confidence interval.

Curative resection (R0) is defined as macroscopically and microscopically complete resection (with microscopic surgical margin assessment according to AJCC Staging Principles).

An R1 resection is defined as macroscopically complete tumor removal with any positive microscopic surgical margin (bile duct, pancreatic parenchyma, or SMA margins).
Up to 4 years postoperative chemotherapy treatment
Relapse/Progression-free Survival
Ramy czasowe: At 2 years post-registration
Relapse/progression-free survival is defined as the time from date of registration to the date of documentation of disease recurrence/progression. If a patient dies without documentation of disease recurrence/progression, the patient will be considered to have had disease recurrence/progression at the time of their death unless there is sufficient documented evidence to conclude no recurrence/progression occurred prior to death. If a patient is declared to be a major treatment violation, the patient will be censored on the date the treatment violation occurred. If a patient is lost to follow-up, s/he will be censored at the data of last contact. The distribution of disease-free survival will be estimated using the method of Kaplan and Meier.
At 2 years post-registration
Number of Participants Experiencing Grade 3 or Higher Adverse Events as Graded by the NCI's Common Toxicity Criteria for Adverse Events
Ramy czasowe: Up to 4 years postoperative chemotherapy treatment
The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns. These patterns will be summarized with descriptive statistics. The number of patients reporting grade 3 or higher adverse events as graded by the NCI's Common Toxicity Criteria (CTCAE) Version 4 are reported here. A complete list of all reported adverse events is reported in the Adverse Events section of this report.
Up to 4 years postoperative chemotherapy treatment
Response Rate
Ramy czasowe: Up to 4 years postoperative chemotherapy treatment
The response rates to preoperative chemotherapy for patients treated with preoperative gemcitabine and erlotinib and rates of accurate pathologic assessment of the resected tumor specimen according to College of American Pathology guidelines will be estimated with a binomial point estimate and corresponding 95% confidence intervals.
Up to 4 years postoperative chemotherapy treatment

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Alliance for Clinical Trials in Oncology

Współpracownicy

National Cancer Institute (NCI)
Astellas Pharma Inc
OSI Pharmaceuticals

Śledczy

  • Krzesło do nauki: Peter W.T. Pisters, MD, M.D. Anderson Cancer Center

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 kwietnia 2009

Zakończenie podstawowe (Rzeczywisty)

1 listopada 2015

Ukończenie studiów (Rzeczywisty)

15 czerwca 2019

Daty rejestracji na studia

Pierwszy przesłany

12 sierpnia 2008

Pierwszy przesłany, który spełnia kryteria kontroli jakości

12 sierpnia 2008

Pierwszy wysłany (Oszacować)

13 sierpnia 2008

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

21 października 2019

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

4 października 2019

Ostatnia weryfikacja

1 października 2019

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • ACOSOG-Z5041
  • U10CA076001 (Grant/umowa NIH USA)
  • NCI-2009-00348 (Inny identyfikator: NCI Clinical Trial Reporting Office)
  • CDR0000609871 (Identyfikator rejestru: NCI Physician Data Query)

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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Badania kliniczne na terapeutyczna chirurgia konwencjonalna

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