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Panitumumab, Docetaxel, Cisplatin, Radiation Therapy, and Surgery in Treating Patients With Newly Diagnosed, Locally Advanced Esophageal Cancer or Cancer of the Gastroesophageal Junction

10 februari 2016 bijgewerkt door: Alliance for Clinical Trials in Oncology

A Phase II Study of Neoadjuvant Therapy With Cisplatin, Docetaxel, Panitumumab Plus Radiation Therapy Followed by Surgery in Patients With Locally Advanced Adenocarcinoma of the Distal Esophagus

RATIONALE: Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to kill tumor cells or stop them from growing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with panitumumab and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well giving panitumumab together with docetaxel, cisplatin, radiation therapy, and surgery works in treating patients with newly diagnosed, locally advanced esophageal cancer or cancer of the gastroesophageal junction.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

OBJECTIVES:

Primary

  • To determine the pathologic complete response rate in patients with newly diagnosed, locally advanced adenocarcinoma of the distal esophagus or gastroesophageal junction treated with neoadjuvant panitumumab and combination chemoradiotherapy followed by surgery.

Secondary

  • To determine the near-complete pathologic response rate in the primary tumor (≤ 10% residual viable cancer).
  • To determine the overall survival and disease-free survival rates of these patients.
  • To determine the safety profile of this regimen.

OUTLINE: Patients receive panitumumab IV over 1 hour, docetaxel IV over 1 hour, and cisplatin IV over 1-2 hours on day 1 in weeks 1, 3, 5, 7, and 9. Patients also undergo radiotherapy once daily 5 days a week beginning in week 5 and continuing for 5.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Beginning 6-9 weeks after completion of chemoradiotherapy, patients with no evidence of metastatic disease undergo esophagectomy.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 1 year OR every 6 months for 3 years.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

70

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Georgia
      • Savannah, Georgia, Verenigde Staten, 31403-3089
        • Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
    • Illinois
      • Chicago, Illinois, Verenigde Staten, 60637-1470
        • University of Chicago Cancer Research Center
      • Chicago, Illinois, Verenigde Staten, 60611-3013
        • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
      • Evanston, Illinois, Verenigde Staten, 60201-1781
        • Evanston Hospital
      • Springfield, Illinois, Verenigde Staten, 62794-9677
        • Simmons Cooper Cancer Institute
    • Kentucky
      • Lexington, Kentucky, Verenigde Staten, 40503-9985
        • Central Baptist Hospital
    • Michigan
      • Royal Oak, Michigan, Verenigde Staten, 48073
        • William Beaumont Hospital - Royal Oak Campus
    • Minnesota
      • Rochester, Minnesota, Verenigde Staten, 55905
        • Mayo Clinic Cancer Center
    • Missouri
      • Saint Louis, Missouri, Verenigde Staten, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
    • New Hampshire
      • Lebanon, New Hampshire, Verenigde Staten, 03756-0002
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
    • North Carolina
      • Charlotte, North Carolina, Verenigde Staten, 28232-2861
        • Blumenthal Cancer Center at Carolinas Medical Center
      • Winston-Salem, North Carolina, Verenigde Staten, 27157-1096
        • Wake Forest University Comprehensive Cancer Center
    • Ohio
      • Dayton, Ohio, Verenigde Staten, 45406
        • Good Samaritan Hospital
      • Greenville, Ohio, Verenigde Staten, 45331
        • Wayne Hospital
      • Kettering, Ohio, Verenigde Staten, 45429
        • Charles F. Kettering Memorial Hospital
    • Oregon
      • Portland, Oregon, Verenigde Staten, 97213-2967
        • Providence Cancer Center at Providence Portland Medical Center
      • Portland, Oregon, Verenigde Staten, 97227
        • Legacy Emanuel Hospital and Health Center and Children's Hospital
    • Pennsylvania
      • Danville, Pennsylvania, Verenigde Staten, 17822-0001
        • Geisinger Cancer Institute at Geisinger Health
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15232
        • UPMC Cancer Centers
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15212
        • Allegheny Cancer Center at Allegheny General Hospital
    • South Carolina
      • Charleston, South Carolina, Verenigde Staten, 29425
        • Hollings Cancer Center at Medical University of South Carolina

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

  1. ≥ 18 years old
  2. ECOG/Zubrod Performance Status 0-1

  3. Biopsy-proven resectable primary (nonrecurrent) adenocarcinoma of the distal esophagus or GE junction (Siewert Type I or II)

    • Siewert Type I: adenocarcinoma of the distal esophagus
    • Siewert Type II: adenocarcinoma of the esophago-gastric junction/real cardia
  4. Pre-registration EUS, CT of chest and upper abdomen, and PET must support a clinical stage of T3N0M0, T2-3N1M0 or T2-3N0-1M1a (celiac adenopathy must be ≤ 2 cm by EUS). Clinically staged T1 tumors and T2N0M0 tumors are not eligible. N1 does not require biopsy/FNA. Note: Patients requiring a stent for nutrition must have staging examinations and scans completed before stent placement.
  5. No definitive radiological evidence of distant metastases.
  6. No pre-existing grade 2 or greater peripheral neuropathy (CTCAE v3) of any etiology.

  7. Adequate bone marrow, hepatic and renal function prior to registration:

    • WBC ≥ 3,000/mm³
    • ANC ≥ 1,500/mm³
    • Platelet count ≥ 100,000/mm³
    • Hemoglobin ≥ 9.5 g/dL
    • Creatinine ≤ 1.5 mg/dL
    • Total bilirubin ≤ 3 mg/dL
    • AST (SGOT) ≤ 2.0 times upper limit of normal (ULN)
    • ALT (SGPT) ≤ 2.0 times ULN
    • Alkaline phosphatase ≤ 2.0 times ULN
    • Albumin ≥ 2.0 g/dL OR prealbumin ≥ 15 mg/dL
    • Magnesium ≥ lower limit of normal (LLN)
  8. Patient must be evaluated before registration by medical oncologist, radiation oncologist and surgeon and deemed fit for protocol therapy and surgery.
  9. No prior invasive malignancy, unless disease-free for ≥ 5 years prior to registration (Exceptions: non-melanoma skin cancer, in-situ cancers).
  10. 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 an effective method of birth-control while receiving study therapy and for six months after completion of therapy.
  11. No prior chest or upper abdomen radiotherapy; prior therapy with cisplatin, docetaxel, panitumumab or other anti-EGFR therapy or prior esophageal or gastric surgery (Exception: prior surgery to treat reflux disease)
  12. No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psyschiatric illness/social situations that would limit compliance with study requirements.
  13. No history of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis or any evidence of interstitial lung disease on baseline chest CT scan
  14. No history of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with the study participation or investigational product(s) administration or may interfere with the interpretation of the results.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: Docetaxel + Cisplatin + Panitumumab + RT
Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
Geneesmiddel: docetaxel
Straling: bestralingstherapie
Procedure: therapeutische conventionele chirurgie
Procedure: neoadjuvante therapie
Geneesmiddel: cisplatine
Biologisch: panitumumab

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants With Pathologic Complete Response Following Surgery
Tijdsspanne: Post surgery
Pathologic complete response (pCR) was defined as no viable residual tumor cells. A cellular residual mucin pools should be noted but also considered a pathologic complete response.
Post surgery

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants With Near-complete Response Rate (≤ 10% Residual Cancer in Primary Tumor Viable)
Tijdsspanne: Post surgery
Post surgery
Percentage of Participants With 3-year Overall Survival
Tijdsspanne: 3 years
Survival time was defined to be the length of time from start of study therapy to death due to any cause or until last follow-up (censored value).
3 years
Percentage of Participants With 2-year Disease-free Survival
Tijdsspanne: 2 years
Disease-free survival was defined as the time from start of study therapy to documentation of disease recurrence. Participants who died without documentation of recurrence were considered to have had tumor recurrence at the time of death unless there was documented evidence that no recurrence occured before death. Participants who failed to return for evaluation after beginning therapy were censored for recurrence on the last day of therapy. Participants who experienced major treatment violations were censored for recurrence on the date the treatment violation occured.
2 years
Number of Participants With Frequent (>=15% Grade 3/4 Incidence) Adverse Events Regardless of Attribution
Tijdsspanne: Week 1, 3, 5, 7, 9, 4-6 weeks after therapy and within 30 days post surgery
Adverse events were assessed by NCI CTCAE (Common Terminology Criteria for Adverse Events) v3.0. Grade 1= mild, grade 2= moderate, grade 3= severe, grade 4= life-threatening; and grade 5= death.
Week 1, 3, 5, 7, 9, 4-6 weeks after therapy and within 30 days post surgery

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Alliance for Clinical Trials in Oncology

Medewerkers

National Cancer Institute (NCI)
Amgen

Onderzoekers

  • Studie stoel: A. Craig Lockhart, MD, Washington University School of Medicine

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 januari 2009

Primaire voltooiing (Werkelijk)

1 november 2011

Studie voltooiing (Werkelijk)

1 december 2014

Studieregistratiedata

Eerst ingediend

22 september 2008

Eerst ingediend dat voldeed aan de QC-criteria

22 september 2008

Eerst geplaatst (Schatting)

23 september 2008

Updates van studierecords

Laatste update geplaatst (Schatting)

11 maart 2016

Laatste update ingediend die voldeed aan QC-criteria

10 februari 2016

Laatst geverifieerd

1 februari 2016

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ACOSOG-Z4051
  • U10CA076001 (Subsidie/contract van de Amerikaanse NIH)
  • CDR0000596674 (Register-ID: Physician Data Query)
  • NCI-2009-00346 (Register-ID: NCI Clinical Trials Reporting Office)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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