- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00591123
Study of Erlotinib and Chemotherapy for Unresectable or Metastatic Cancer of the Esophagus and Gastric Cardia
A Phase II Study of Erlotinib and Modified FOLFOX-6 (5-Fluorouracil, Leucovorin and Oxaliplatin) in Previously Untreated Patients With Unresectable or Metastatic Adenocarcinoma of the Esophagus and Gastric Cardia
In this study, Erlotinib and 5-Fluorouracil (5-FU), Leucovorin and Oxaliplatin (a regimen known also as FOLFOX-6) will be the chemotherapy study drugs. The main purpose of this study is to test the safety and effectiveness of this combination of chemotherapy drugs and to see how they affect your cancer.
Another purpose of this study is to examine samples from your blood and tumor. This research will be done to better understand how subjects respond to treatment. Specifically, researchers will look at the way your genes and proteins respond to drugs like those used in this study.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
-
-
California
-
Los Angeles, California, Vereinigte Staaten, 90095
- UCLA Jonsson Comprehensive Cancer Center
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Los Angeles, California, Vereinigte Staaten, 90095
- Translational Oncology Research International (TORI) Network
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Metastatic or unresectable adenocarcinoma of the upper gastrointestinal tract that can be measured in at least one dimension according to RECIST criteria by CT or MRI
- Gastric adenocarcinomas may be included if the primary tumor arises within 5 cm of the anatomic gastro-esophageal junction (distal esophagus) or from the gastric cardia as indicated by either endoscope or imaging.
- Previously untreated with chemotherapeutic agents for unresectable or metastatic disease.
- Adjuvant chemotherapy and/or radiotherapy are allowed as long as no oxaliplatin was used in the past 12 months.
- ECOG performance status 0 or 1
- Age > 18 years old.
- Life expectancy greater than 6 months.
- Peripheral neuropathy: must be < grade 1
- Absolute neutrophil count > 1,500/mm3
- Hemoglobin > 9.0 g/dl
- Platelet count > 100,000/mm3
Hepatic Function:
- Total Bilirubin < or = to 1.5 x ULN
- AST and ALT must be < or = to 3.0 x ULN (< or = to 5.0 x ULN if there is liver metastasis).
Creatinine clearance of > 60 ml/min as calculated by the Cockcroft Gault formula. (Ccr = ((140-Age) X Wt (kg))/ (72 X SCr (mg/100ml) for males).
(Ccr = ((140-Age) X Wt (kg))/ (72 X SCr (mg/100ml) x 0.85 for females)
- Women of childbearing potential must have a negative pregnancy test by urine or serum testing.
- Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 4 months after the last treatment.
- Patients must have signed IRB approved informed consent
- Patients must have the ability to comply with study and follow-up procedures.
Exclusion Criteria:
- Patients with known hypersensitivity to any components of oxaliplatin, leucovorin, 5-fluorouracil (or other fluoropyrimidines) or erlotinib.
- Women who are breast-feeding or pregnant.
- Presence of > Grade 2 neuropathy
- Patients with prior malignancy other than non-melanoma skin cancer or cervical carcinoma in situ within the past five years
- Current or prior history of central nervous system or brain metastases
- Any other medical conditions, which, in the opinion of the investigator, would preclude subjects to participate in the study.
- Patients who have received chemotherapy, surgery or radiation therapy within 30 days prior to the first dose.
- INR greater than 3.5 for patients on warfarin
- Known HIV infection
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: FOLFOX, plus 5-FU and Erlotinib
single arm
|
Once every two weeks all patients will receive Oxaliplatin 85 mg/m2 IV, Leucovorin 400 mg/m2 IV and 5-FU 400 mg/m2 IV infusions
Andere Namen:
5-FU 2400 mg/m2 IV will be given via pump for 46-48 hours at home.
Andere Namen:
All patients will also be given Erlotinib, 100 mg orally daily for the first 4 weeks.
Those patients who have not experienced toxicities will increase the dose level to 150 mg daily.
Patients who have toxicities will remain at the 100 mg dose level or lower if necessary.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Overall Response Rate of Previously-untreated Patients With Unresectable or Metastatic Adenocarcinomas of the Upper Gastrointestinal Tract When Treated With the Combination of 5-fluorouracil, Leucovorin, Oxaliplatin, and Erlotinib.
Zeitfenster: 3.5 years
|
Per response evaluation criteria in solid tumors criteria (RECIST) for target lesions and assessed by computerized tomography (CT) scan. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions |
3.5 years
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Toxicity of the Combination of FOLFOX, 5-FU, and Erlotinib
Zeitfenster: 3.5 years
|
Adverse event assessment by investigators and as reported by subjects from time of consent to 30 days after last dose.
Up to 3.5 years.
|
3.5 years
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Zev Wainberg, MD, University of California, Los Angeles
- Studienleiter: Fairooz Kabbinavar, MD, UCLA - TORI
- Studienstuhl: J Randolph Hecht, MD, University of California, Los Angeles
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Verdauungssystems
- Neubildungen nach histologischem Typ
- Neubildungen
- Neubildungen nach Standort
- Karzinom
- Neubildungen, Drüsen und Epithelien
- Gastrointestinale Neubildungen
- Neoplasmen des Verdauungssystems
- Magen-Darm-Erkrankungen
- Kopf-Hals-Neubildungen
- Erkrankungen der Speiseröhre
- Adenokarzinom
- Ösophagusneoplasmen
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Enzym-Inhibitoren
- Antimetaboliten, antineoplastisch
- Antimetaboliten
- Antineoplastische Mittel
- Immunsuppressive Mittel
- Immunologische Faktoren
- Schutzmittel
- Mikronährstoffe
- Proteinkinase-Inhibitoren
- Vitamine
- Gegenmittel
- Vitamin B-Komplex
- Erlotinib-Hydrochlorid
- Fluorouracil
- Oxaliplatin
- Leucovorin
- Levoleucovorin
Andere Studien-ID-Nummern
- TORI GI-05
- BB-IND 77,805 (Andere Kennung: FDA)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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