- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00062322
Neoadjuvant Chemoradiotherapy Followed By Surgery in Treating Patients With Limited-Stage Small Cell Lung Cancer
Phase I Study of Preoperative Chemo/Radiation (Concurrent Irinotecan/Cisplatin/RT) Followed by Surgery in Limited Stage Small Cell Lung Cancer (SCLC-LS)
RATIONALE: Drugs used in chemotherapy such as irinotecan and cisplatin use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Irinotecan and cisplatin may also make the tumor cells more sensitive to radiation therapy. Combining chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed during surgery.
PURPOSE: This phase I trial is studying the side effects of neoadjuvant radiation therapy given together with irinotecan and cisplatin followed by surgery in treating patients with limited-stage small cell lung cancer.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
OBJECTIVES:
- Determine the safety and feasibility of neoadjuvant chemoradiotherapy with irinotecan and cisplatin followed by surgery in patients with limited stage small cell lung cancer.
- Determine the pathologic complete response rate of patients treated with this regimen.
- Correlate the level of vascular endothelial growth factor with treatment response and disease outcome in patients treated with this regimen.
- Correlate genetic polymorphisms in cytochrome P450 1A1, glutathione S-transferase M1 and P1, myeloperoxidase, and NAD(p)H: quinone oxidoreductase with treatment response and disease outcome in patients treated with this regimen.
OUTLINE: This is a pilot study.
- Induction chemotherapy: Patients receive cisplatin IV over 1 hour on day 1 and irinotecan IV over 90 minutes on days 1 and 8.
- Chemoradiotherapy: Beginning on day 21, patients receive chemoradiotherapy comprising radiotherapy once daily, 5 days a week for 4 weeks and then twice daily for 4 days. Patients also receive cisplatin IV and irinotecan IV over 30-60 minutes once weekly concurrently with radiotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
At the completion of chemoradiotherapy, patients are evaluated for surgery. Patients who are candidates for surgery receive one additional course of cisplatin IV and irinotecan IV. Patients who are not candidates for surgery receive radiotherapy twice daily for 4 days and cisplatin IV and irinotecan IV as in chemoradiotherapy.
- Surgery: Approximately 2-4 weeks after the last dose of chemotherapy, patients undergo surgery.
Patients are followed every 4 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Studientyp
Phase
- Phase 1
Kontakte und Standorte
Studienorte
-
-
Pennsylvania
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19111-2497
- Fox Chase Cancer Center
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed small cell lung cancer
Limited stage disease (clinical stage I-IIIA) and meets the following criteria:
- Confined to 1 hemithorax
- No T4 disease based on malignant pleural effusion
- No N3 disease based on contralateral hilar or supraclavicular involvement
- Contralateral mediastinal (N3) nodes greater than 1.5 cm on CT scan must be biopsied to rule out pathologic involvement
- Measurable or evaluable disease
- Tumor must be able to be encompassed by limited radiotherapy field without significantly compromising pulmonary function
- No pleural effusion visible on chest x-ray (regardless of cytology)
- No prior complete tumor resection
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 70-100%
Life expectancy
- Not specified
Hematopoietic
- Absolute granulocyte count at least 1,800/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 1.5 mg/dL
- No known Gilbert's disease
Renal
- Creatinine no greater than 1.5 mg/dL
- Calcium less than 12.0 mg/dL
Cardiovascular
- No myocardial infarction within the past 6 months
- No congestive heart failure
- No uncontrolled arrhythmias
- No active unstable angina
Pulmonary
- Calculated postoperative FEV_1 at least 800 cc
- No chronic obstructive pulmonary disease with FEV_1 no greater than 1 L or uncontrolled bronchospasm in the unaffected lung
Other
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancy within the past 2 years except curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any other noninvasive malignancy
- No history of seizures
- No history of uncontrolled psychiatric illness that would preclude giving informed consent or complying with study
- No active or uncontrolled infection
- No uncontrolled diabetes mellitus (random blood sugar at least 250 mg/dL)
- No other concurrent serious medical illness
- HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior irinotecan
- No prior topotecan
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy to the chest or other areas containing 30% or more of marrow-bearing bone
Surgery
- See Disease Characteristics
Other
- No concurrent phenytoin, phenobarbital, or other antiepileptic prophylactic drugs
- No concurrent amifostine
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Studienstuhl: Steven Feigenberg, MD, Fox Chase Cancer Center
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen der Atemwege
- Neubildungen
- Lungenkrankheit
- Neubildungen nach Standort
- Neubildungen der Atemwege
- Thoraxneoplasmen
- Karzinom, bronchogen
- Bronchiale Neubildungen
- Lungentumoren
- Kleinzelliges Lungenkarzinom
- Molekulare Mechanismen der pharmakologischen Wirkung
- Enzym-Inhibitoren
- Antineoplastische Mittel
- Topoisomerase-Inhibitoren
- Topoisomerase I-Inhibitoren
- Irinotecan
Andere Studien-ID-Nummern
- CDR0000304720
- P30CA006927 (US NIH Stipendium/Vertrag)
- FCCC-02613
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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