Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Gefitinib, Cisplatin, Irinotecan, and Radiation Therapy Before Surgery in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer That Can Be Removed By Surgery

7. Mai 2014 aktualisiert von: University of California, San Francisco

A Phase I/II Study to Evaluate Safety and Efficacy in Patients Who Have Resectable Esophageal Cancer and Are Treated With Neoadjuvant Cisplatin, Irinotecan (CPT-11) ZD1839 (IRESSA), and Radiotherapy Followed by Surgical Resection

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving gefitinib together with chemotherapy 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 I/II trial is studying the side effects of gefitinib when given together with cisplatin, irinotecan, and radiation therapy before surgery and to see how well they work in treating patients with esophageal cancer or gastroesophageal junction cancer that can be removed by surgery.

Studienübersicht

Status

Beendet

Bedingungen

Speiseröhrenkrebs

Intervention / Behandlung

Detaillierte Beschreibung

OBJECTIVES:

Primary

Evaluate the pathologic response (complete and partial) in patients with resectable esophageal or gastroesophageal junction cancer treated with neoadjuvant gefitinib, cisplatin, irinotecan hydrochloride, and radiotherapy followed by surgical resection.

Secondary

Assess the safety and toxicity of this regimen in these patients.
Evaluate objective tumor response in patients treated with this regimen.
Determine the rate of complete resection in patients treated with this regimen.
Determine surgical morbidity and mortality in patients treated with this regimen.

OUTLINE: This is an open-label study.

Induction phase: Patients receive oral gefitinib once daily on days 1-14. Patients with stable or responding disease proceed to neoadjuvant chemoradiotherapy.
Neoadjuvant chemoradiotherapy: Patients receive gefitinib as in the induction phase beginning in week 4 and continuing through the last day of radiotherapy. Patients also receive cisplatin IV over 1 hour and irinotecan hydrochloride IV over 30 minutes on days 22, 29, 43, and 50 and undergo radiotherapy once daily, 5 days a week, for 5 weeks (total of 25 doses).
Surgery: Within 4-8 weeks after completion of neoadjuvant chemoradiotherapy, patients with stable or responding disease undergo an esophagectomy and lymph node dissection. Patients with a progressive or unresectable disease are removed from the study.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

Phase

Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

Vereinigte Staaten
- California
  - San Francisco, California, Vereinigte Staaten, 94115
    - UCSF Helen Diller Family Comprehensive Cancer Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

DISEASE CHARACTERISTICS:

Histologically confirmed adenocarcinoma (AC) or squamous cell carcinoma of the esophagus
- AC of the gastroesophageal junction allowed
Tumor must be considered surgically resectable (T1-3, NX)
- No early-stage cancer (T1, N0)
The following lymph node (LN) criteria are considered acceptable:
- Regional thoracic LN metastases (N1)
- LN metastases levels 15 to 20 measured as ≤ 1.5 cm by CT scan
- Supraclavicular LN not palpable on clinical examination measured as ≤ 1.5 cm by CT scan
No distant metastases (M0)

PATIENT CHARACTERISTICS:

Platelet count ≥ 100,000/mm^3
Absolute neutrophil count ≥ 1,500/mm^3
Hemoglobin ≥ 9.0 g/dL
Creatinine clearance ≥ 50 mL/min
Creatinine serum level ≤ CTC grade 2
Bilirubin ≤ 2 times upper limit of normal (ULN)
AST < 3 times ULN
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 3 months after completion of study treatment
No known severe hypersensitivity to gefitinib or any of its excipients
No evidence (except asymptomatic chronic stable radiographic changes) of clinically active interstitial lung disease
No pulmonary fibrosis, Gilbert's disease, uncontrolled diabetes mellitus, or unstable angina
No New York Heart Association class III or IV heart disease
No other concurrent malignancies or malignancies diagnosed within the past 5 years except basal cell carcinoma or carcinoma in situ of the cervix
No serious active or uncontrolled infection, systemic disease, psychiatric illness, or other medical condition that would preclude study participation
No evidence of any significant clinical disorder or laboratory finding that would preclude study participation

PRIOR CONCURRENT THERAPY:

No prior chemotherapy or radiotherapy for esophageal cancer
No prior radiotherapy that would overlap the study treatment fields
Recovered from prior major surgery
No nonapproved or investigational drugs within the past 30 days
No concurrent phenytoin, carbamazepine, barbiturates, rifampin, phenobarbital, or Hypericum perforatum (St. John's wort)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Hauptzweck: Behandlung
Zuteilung: N / A
Interventionsmodell: Einzelgruppenzuweisung
Maskierung: Keine (Offenes Etikett)

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Pathological response (complete and partial) post-operatively

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Safety and toxicity post-operatively
Response rate 2 weeks into treatment, pre-operatively, and post-operatively
Completeness of resection post-operatively
Surgical morbidity and mortality post-operatively
Compare the effects of gefitinib on biomarkers that effect EGF signaling and genomic composition of tumor samples before and after treatment

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of California, San Francisco

Mitarbeiter

National Cancer Institute (NCI)

Ermittler

Studienstuhl: Andrew Ko, MD, University of California, San Francisco

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. November 2005

Primärer Abschluss (Tatsächlich)

1. April 2008

Studienabschluss (Tatsächlich)

1. Juni 2008

Studienanmeldedaten

Zuerst eingereicht

9. Februar 2006

Zuerst eingereicht, das die QC-Kriterien erfüllt hat