- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00118235
Cisplatin, Irinotecan, and Bevacizumab, in Treating Patients With Small Cell Lung Cancer
Cisplatin, Irinotecan and Bevacizumab (NSC# 704865) for Untreated Extensive Stage Small Cell Lung Cancer: A Phase II Study
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
PRIMARY OBJECTIVES:
I. To determine the percentage of patients with extensive stage small cell lung cancer treated with cisplatin, irinotecan and bevacizumab who live longer than 12 months.
SECONDARY OBJECTIVES:
I. To assess the response rate of patients treated with cisplatin, irinotecan and bevacizumab.
II. To evaluate the toxicity and tolerability of the combination of cisplatin, irinotecan and bevacizumab.
III. To determine the association between VEGF/KDR complex expression and VEGF plasma levels and tumor response.
OUTLINE:
Patients receive cisplatin IV over 60 minutes and irinotecan IV over 90 minutes on days 1 and 8. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 3 years.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
-
-
Illinois
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Chicago, Illinois, Vereinigte Staaten, 60606
- Cancer and Leukemia Group B
-
-
Rhode Island
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Providence, Rhode Island, Vereinigte Staaten, 02903
- Rhode Island Hospital
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- All patients must have histologically or cytologically documented small cell carcinoma of the bronchus
- The extensive disease classification for this protocol includes all patients with disease sites not defined as limited stage; limited stage disease category includes patients with disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal, and/or ipsilateral supraclavicular nodes; extensive stage patients are defined as those patients with extrathoracic metastases, malignant pleural effusion, bilateral or contralateral supraclavicular adenopathy or contralateral hilar adenopathy
- Measurable or Non-measurable Disease
- No prior chemotherapy or investigational therapy for SCLC
- Radiation therapy must have been completed at least three weeks before initiation of protocol therapy
- No major surgical procedure within 28 days prior to starting treatment and fully recovered
- No minor surgical procedure (mediastinoscopy or core biopsy) within 7 days prior to starting treatment
- ECOG performance status: 0-2
- No "currently active" second malignancy other than non-melanoma skin cancers
- No CNS metastases; patients with a history of CNS metastases will NOT be eligible even if they have completed a course of CNS radiotherapy; all patients will have a screening brain CT or MRI to rule out occult CNS metastases
- No recent history of CVA (within 6 months)
- No serious or non-healing wound ulcer or bone fracture
- Patients with a history of significant bleeding episodes (e.g., hemoptysis, bleeding diathesis, upper or lower GI bleeding) are not eligible; patients with trace blood in the sputum ("blood tinged sputum") are eligible
- No myocardial infarction or significant change in anginal pattern within one year or current congestive heart failure (NYHA Class 2 or higher)
- Patients with a history of hypertension must be well controlled (< 150/90) on a stable regimen of anti-hypertensive therapy
- No HIV-positive patients receiving combination anti-retroviral therapy because of possible pharmacokinetic interactions with the protocol treatment; (patients with immune deficiency are at an increased risk of lethal infections when treated with marrow-suppressive therapy)
- No chronic daily treatment with aspirin (> 325 mg/day) or on non-steroidal antiinflammatory agents known to inhibit platelet function; no treatment with dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix), cilostazol (Pletal), or other antiplatelet agents
- No clinically significant peripheral neuropathy (grade >= 2)
- No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
- No treatment with therapeutic anticoagulation; prophylactic anticoagulation for central venous access devices is allowed provided requirements of INR < 1.5 and PTT < 1.2 x ULN are met; caution should be taken in treating patients with low dose heparin or low molecular weight heparin for DVT prophylaxis as there may be an increased bleeding risk with bevacizumab
- No current and/or recent (within 1 month) use of a thrombolytic agent; low dose thrombolytic therapy for maintenance of central venous catheter is allowed
- No clinically significant peripheral arterial disease
- Non-pregnant and non-nursing; the effect of the combination of bevacizumab, cisplatin, and irinotecan on the fetus and infant is unknown
- Granulocytes >= 1,500/μl
- Platelets >= 100,000/μl
- Serum Creatinine =< ULN
- Total Bilirubin < 2.0 mg/dl
- SGOT < 2 x ULN
- INR < 1.5
- PTT < 1.2 x ULN
- Urine protein (dipstick) < 1+
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: Treatment (cisplatin, irinotecan hydrochloride, bevacizumab)
Patients receive cisplatin IV over 60 minutes and irinotecan IV over 90 minutes on days 1 and 8. Patients also receive bevacizumab IV over 30-90 minutes on day 1.
Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
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Korrelative Studien
Gegeben IV
Andere Namen:
Gegeben IV
Andere Namen:
Gegeben IV
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Survival time
Zeitfenster: The time beginning at randomization until death or last known follow-up, assessed up to 4 years
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Described using Kaplan-Meier curves.
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The time beginning at randomization until death or last known follow-up, assessed up to 4 years
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Failure-free survival
Zeitfenster: The time between randomization and the occurrence of disease progression, or death, whichever comes first, assessed up to 4 years
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Described using Kaplan-Meier curves.
|
The time between randomization and the occurrence of disease progression, or death, whichever comes first, assessed up to 4 years
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Frequency of toxicity, tabulated by the most severe occurrence
Zeitfenster: Up to 4 years
|
Graded using the NCI CTCAE version 3.0.
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Up to 4 years
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Neal Ready, Cancer and Leukemia Group B
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 (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen der Atemwege
- Neubildungen
- Lungenkrankheit
- Neubildungen nach Standort
- Neubildungen der Atemwege
- Thoraxneoplasmen
- Karzinom, bronchogen
- Bronchiale Neubildungen
- Lungentumoren
- Kleinzelliges Lungenkarzinom
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Enzym-Inhibitoren
- Antineoplastische Mittel
- Immunologische Faktoren
- Topoisomerase-Inhibitoren
- Angiogenese-Inhibitoren
- Angiogenese-modulierende Mittel
- Wuchsstoffe
- Wachstumshemmer
- Topoisomerase I-Inhibitoren
- Antikörper
- Cisplatin
- Immunglobuline
- Bevacizumab
- Irinotecan
- Antikörper, monoklonal
- Antineoplastische Mittel, immunologische
Andere Studien-ID-Nummern
- NCI-2012-02815 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))
- U10CA031946 (US NIH Stipendium/Vertrag)
- P30CA014236 (US NIH Stipendium/Vertrag)
- CDR0000433341
- CALGB-30306 (Andere Kennung: CTEP)
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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