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- Klinische proef NCT01561014
Oxaliplatin, Fluorouracil, Erlotinib Hydrochloride, and Radiation Therapy Before Surgery and Erlotinib Hydrochloride After Surgery in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction
A Phase I Study of Preoperative Chemoradiation With Oxaliplatin, 5-Fluorouracil, Erlotinib and Radiation Followed by Resection and Consolidative Erlotinib for Patients With Locally Advanced Cancer of the Esophagus and Gastroesophageal Junction
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
- Geneesmiddel: oxaliplatine
- Geneesmiddel: fluoruracil
- Straling: bestralingstherapie
- Geneesmiddel: erlotinib hydrochloride
- Procedure: analyse van biomarkers in het laboratorium
- Ander: immunohistochemische kleuringsmethode
- Procedure: conventional surgery
- Procedure: positron emission tomography
- Procedure: computed tomography
- Genetisch: gene expression analysis
- Straling: fludeoxyglucose F 18
Gedetailleerde beschrijving
OBJECTIVES:
I. The primary aim of this phase I study is to evaluate the safety of multi-drug chemotherapy (with the addition of an anti-epidermal growth factor receptor [EGFR] agent erlotinib [erlotinib hydrochloride]) and concomitant radiotherapy followed by resection and consolidative erlotinib for the treatment of locally advanced esophageal cancer as judged by the dose limiting toxicities. Correlative endpoints include an analysis of pre-treatment tumor cyclin D1 expression and EGFR expression/amplification.
III. Correlate pathologic complete response with changes in fludeoxyglucose F 18 (FDG)-positron emission tomography (PET)-computed tomography (CT) - pre and post-chemoradiation.
OUTLINE: This is a dose escalation study of erlotinib hydrochloride
CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily (QD), 5 days a week and receive fluorouracil intravenously (IV) continuously and erlotinib hydrochloride orally (PO) QD on days 1-38. Patients also receive oxaliplatin IV over 2 hours on days 1, 15, and 29.
SURGERY: Within 4-8 weeks after completion of chemoradiotherapy, patients with potentially resectable disease (i.e., complete response, partial response, or stable disease) undergo surgery to remove the tumor.
CONSOLIDATION CHEMOTHERAPY: Within 2-4 weeks after surgery, patients with tumors that demonstrate positive immunohistochemistry for EGFR and/or cyclin D1 (in the pretreatment biopsy or in the residual tumor in the esophagectomy specimen) receive consolidation chemotherapy comprising erlotinib hydrochloride PO QD for 12 weeks.
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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North Carolina
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Winston-Salem, North Carolina, Verenigde Staten, 27157
- Wake Forest University Health Sciences
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Newly diagnosed patients with locally advanced esophageal cancer with either squamous or adenocarcinoma histology; patients should have evidence of extension of disease into or through the wall of the esophagus (T2-4) and/or regional nodal metastasis (N1)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Non-pregnant; patients of childbearing potential and their partners must agree to use an effective form of contraception during the study and for 90 days following the last dose of study medication (an effective form of contraception is an oral contraceptive or a double barrier method); nursing mothers are also ineligible
- Prior treatment: Greater than one week shall have elapsed since any major surgery; no prior chemotherapy or radiotherapy is allowed
- Adequate whole blood cell (WBC) and platelets (Plt) as determined by medical oncology
- Serum creatinine =< 1.5 mg/dl
- Creatinine clearance >= 60 ml/min
- Hemoglobin (Hgb) >= 9.0 gm/dl
- Absolute neutrophil count >= 1,500/uL
- Serum total bilirubin =< 1.5 mg/dL
- Alkaline phosphatase =< 3X the upper limit of normal (ULN) for the reference lab
- Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less than 2X ULN for the reference laboratory
- Patients must be told of the investigational nature of the study and must sign a written informed consent
- No serious medical or psychiatric illnesses which would prevent informed consent or otherwise limit survival to less than two years; no history of refractory congestive heart failure or cardiomyopathy
- Patients should be evaluated by medical oncology, radiation oncology, and surgery, and felt to by all to be suitable for trimodality therapy
Exclusion Criteria:
Patients with an active infection or with a fever >= 38.5 degrees Celsius (C) within 3 days of the first scheduled day of protocol treatment
- History of prior malignancy within the past 5 years except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or localized prostate cancer with a current prostate surface antigen (PSA) of < 1.0 mg/dL on 2 successive evaluations, at least 3 months apart, with the most recent evaluation no more than 4 weeks prior to entry
- Patients with known hypersensitivity to any of the components of oxaliplatin
- Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of protocol treatment (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication)
- Peripheral neuropathy >= Grade 2
- History of allogeneic transplant
- Known human immunodeficiency virus (HIV) or Hepatitis B or C (active, previously treated or both)
- Pregnancy
Studie plan
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 |
---|---|
Experimenteel: Treatment (chemotherapy, enzyme inhibitor therapy)
CHEMORADIOTHERAPY: Patients undergo radiation therapy QD, 5 days a week and receive fluorouracil IV continuously and erlotinib hydrochloride PO QD on days 1-38. Patients also receive oxaliplatin IV over 2 hours on days 1, 15, and 29. SURGERY: Within 4-8 weeks after completion of chemoradiotherapy, patients with potentially resectable disease (i.e., complete response, partial response, or stable disease) undergo surgery to remove the tumor. CONSOLIDATION CHEMOTHERAPY: Within 2-4 weeks after surgery, patients with tumors that demonstrate positive immunohistochemistry for EGFR and/or cyclin D1 (in the pretreatment biopsy or in the residual tumor in the esophagectomy specimen) receive consolidation chemotherapy comprising erlotinib hydrochloride PO QD for 12 weeks. |
IV gegeven
Andere namen:
IV gegeven
Andere namen:
Radiotherapie ondergaan
Andere namen:
Gegeven PO
Andere namen:
Correlatieve studie
Correlatieve studie
Andere namen:
Undergo surgical resection
Andere namen:
Correlative study
Andere namen:
Correlative study
Andere namen:
Correlative study
Undergo F18 PET and CT scan
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Toxicity rate of combination chemotherapy followed by surgery and erlotinib hydrochloride
Tijdsspanne: Approximately 6 months
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Toxicity will be determined using the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 3.0 for Toxicity and Adverse Event Reporting (CTCAE v3.0).
The dose limiting toxicity will be defined as any of the following that can be attributal to therapy: Any grade 4 neutropenia and or any grade 4 thrombocytopenia, or any >= grade 3 non-hematologic toxicity that results in a greater than 3 day interruption of therapy.
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Approximately 6 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Time to progression
Tijdsspanne: Approximately 4 years
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Approximately 4 years
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Survival
Tijdsspanne: Approximately 4 years
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Approximately 4 years
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Specific characteristics that predict complete response rate (e.g., EGFR status, EGFR amplification, and cyclin D1 expression)
Tijdsspanne: Over 4 years
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Over 4 years
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Specific characteristics that predict complete response rate (e.g., EGFR status, EGFR amplification, and cyclin D1 expression)
Tijdsspanne: Approximately 1 year
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Approximately 1 year
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Test the predictive value of FDG-PET-CT imaging in identifying patients who will have a complete response
Tijdsspanne: Approximately 1 year
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Approximately 1 year
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Medewerkers en onderzoekers
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het spijsverteringsstelsel
- Neoplasmata per histologisch type
- Neoplasmata
- Neoplasmata per site
- Carcinoom
- Neoplasmata, glandulair en epitheel
- Gastro-intestinale neoplasmata
- Neoplasmata van het spijsverteringsstelsel
- Gastro-intestinale aandoeningen
- Maag Ziekten
- Hoofd- en nekneoplasmata
- Slokdarmaandoeningen
- Neoplasmata, plaveiselcel
- Carcinoom, plaveiselcel
- Maagneoplasmata
- Adenocarcinoom
- Slokdarmneoplasmata
- Slokdarm plaveiselcelcarcinoom
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Antimetabolieten, antineoplastische
- Antimetabolieten
- Antineoplastische middelen
- Immunosuppressieve middelen
- Immunologische factoren
- Radiofarmaca
- Proteïnekinaseremmers
- Fluorodeoxyglucose F18
- Erlotinibhydrochloride
- Fluoruracil
- Oxaliplatine
Andere studie-ID-nummers
- IRB00007063
- NCI-2009-01447 (Register-ID: CTRP (Clinical Trial Reporting Program))
- CCCWFU 60106 (Andere identificatie: Wake Forest University Health Sciences)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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Klinische onderzoeken op oxaliplatine
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SanofiVoltooid
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Taiho Pharmaceutical Co., Ltd.Yakult Honsha Co., LTDVoltooidColorectale kankerJapan
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Hebei Medical UniversityOnbekendMaagkanker | Lever metastaseChina
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Universidad de LeónWervingLokaal gevorderde darmkankerSpanje
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Wuhan Union Hospital, ChinaWervingVergevorderde maagkanker | Geavanceerde Gastro-oesofageale Junction AdenocarcinoomChina
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SanofiVoltooidMaagkankerKorea, republiek van
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QureBio Ltd.WervingGastro-oesofageale overgang (GEJ) AdenocarcinoomChina
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Xijing HospitalWervingLokaal gevorderd adenocarcinoom van de maagChina
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Kangbuk Samsung HospitalBeëindigdMaagkankerKorea, republiek van
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The First Affiliated Hospital of Zhengzhou UniversityNog niet aan het werven