- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00613626
Cisplatin + Etoposide +/- Concurrent ZD6474 in Previously Untreated Extensive Stage Small Cell Lung Cancer
A Randomized Double Blind Phase II Trial of Cisplatin Plus Etoposide With/Without Concurrent ZD6474 in Patients With Previously Untreated Extensive Stage Small Cell Lung Cancer: Hoosier Oncology Group LUN06-113
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
OUTLINE: This is a multi-center study.
Arm A:
Cisplatin 60mg/m2 Day 1 + Etoposide 120mg/m2 Day 1,2,3 + Placebo oral daily given continuously for the duration of the study
Arm B:
Cisplatin 60mg/m2 Day 1 + Etoposide 120mg/m2 Day 1,2,3 + ZD6474 100mg oral daily given continuously for the duration of the study
For both arms, PE and toxicity evaluation prior to each cycle and disease assessment by imaging every 2 cycles. Patients with non-PD and acceptable toxicity will continue protocol therapy; patients with progressive disease or excessive toxicity will be taken off treatment. Cycles will be repeated every 21 days up to a total of 4 cycles.
ECOG Performance Status of 0 or 1
Life Expectancy: Not specified
Hematopoietic:
- Platelets > 100K/mm3
- Absolute neutrophil count (ANC) > 1.5K/mm3
Hepatic:
- Bilirubin < 1.5 x ULN
- Aspartate aminotransferase (AST) < 2.5 x ULN or < 5 x ULN if judged by the investigator to be related to liver metastases
- Alkaline phosphatase < 2.5 x ULN or < 5 x ULN if judged by the investigator to be related to liver metastases
Renal:
- Serum creatinine < 1.5 x ULN or Calculated creatinine clearance of > 45 cc/min using the Cockcroft-Gault formula
Cardiovascular:
- No clinically significant cardiac event such as myocardial infarction; New York Heart Association (NYHA) classification of heart disease >2 (see SPM) within 3 months prior to registration for protocol therapy
- No presence of cardiac disease that, in the opinion of the Investigator, increases the risk of ventricular arrhythmia.
- No history of arrhythmia (multifocal premature ventricular contractions (PVCs), bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) which is symptomatic or requires treatment (CTCAE grade 3) or asymptomatic sustained ventricular tachycardia. Atrial fibrillation, controlled on medication is permitted.
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 2
Kontakty a umístění
Studijní místa
-
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Delaware
-
Newark, Delaware, Spojené státy, 19713
- Helen F. Graham Cancer Center
-
-
Illinois
-
Chicago, Illinois, Spojené státy, 60611
- Northwestern University Feinberg School of Medicine
-
Galesburg, Illinois, Spojené státy, 61401
- Medical & Surgical Specialists, LLC
-
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Indiana
-
Bloomington, Indiana, Spojené státy, 47403
- Cancer Care Center of Southern Indiana
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Evansville, Indiana, Spojené státy, 47714
- Oncology Hematology Associates of SW Indiana
-
Fort Wayne, Indiana, Spojené státy, 46815
- Fort Wayne Oncology & Hematology, Inc
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Indianapolis, Indiana, Spojené státy, 46202
- Indiana University Simon Cancer Center
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Indianapolis, Indiana, Spojené státy, 46202
- IN Onc/Hem Associates
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Indianapolis, Indiana, Spojené státy, 46206
- St. Vincent Hospital & Health Centers
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Lafayette, Indiana, Spojené státy, 47904
- IU Health Arnett Cancer Center
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Lafayette, Indiana, Spojené státy, 47905
- Horizon Oncology Researcg
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Muncie, Indiana, Spojené státy, 47303
- IU Health at Ball Memorial Hospital
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Munster, Indiana, Spojené státy, 46321
- Monroe Medical Associates
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South Bend, Indiana, Spojené státy, 46601
- Northern Indiana Cancer Research Consortium
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Terre Haute, Indiana, Spojené státy, 47802
- Providence Medical Group
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Nebraska
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Omaha, Nebraska, Spojené státy, 68114
- Methodist Cancer Center
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New Jersey
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Mount Holly, New Jersey, Spojené státy, 08060
- Hematology Oncology Associates S.J., P.A.
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Oregon
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Portland, Oregon, Spojené státy, 97213
- Providence Portland Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Spojené státy, 19106
- Pennsylvania Oncology-Hematology Associates
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Histological or cytological proof of chemotherapy-naïve, extensive, small cell lung cancer.
- Measurable disease according to RECIST and obtained by imaging within 28 days prior to being registered for protocol therapy.
- Written informed consent and HIPAA authorization for release of personal health information.
- Age 18 years or older at the time of consent.
- Potassium ≥4.0 mmol/L and <5.5mmol/L (supplementation is allowed).
- Calcium within normal range (supplementation is allowed).
- Magnesium within normal range (supplementation is allowed).
Exclusion Criteria:
- No prior EGFR inhibitor or antiangiogenic agent allowed.
- No prior hormonal therapy.
- No symptomatic brain metastasis.
- No clinically significant infections as judged by the treating investigator.
- No evidence of severe or uncontrolled other systemic disease or any concurrent condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol.
- No previous history of QTc prolongation as a result of medication that required discontinuation of that medication.
- No congenital long QT syndrome or known 1st degree relative with unexplained sudden death under 40 years of age.
- No presence of left bundle branch block (LBBB.)
- No QTc with Bazett's correction that is unmeasurable, or ≥480 msec on screening ECG obtained within 7 days prior to registration for protocol therapy. If a subject has QTc ≥480 msec on screening ECG, the screen ECG may be repeated twice (at least 24 hours apart). The average QTc from the three screening ECGs must be <480 msec in order for the subject to be eligible for the study.
- No concomitant (within 14 days prior to registration for and during protocol therapy) medication associated with Torsades de Pointes or cause QTc prolongation, is allowed. Medications that prolong QT, but are not strictly associated with Torsades, are allowed if medically necessary and will require increased ECG and electrolyte monitoring.
- No uncontrolled hypertension (systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg).
- No currently active diarrhea that may affect the ability to absorb ZD6474.
- No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, Gleason < grade 7 prostate cancers, or other cancer for which the subject has been disease-free for at least 5 years.
- Major surgery must be completed greater than 28 days prior to registration for protocol therapy and healed surgical incision is required.
- No concomitant (within 14 days prior to registration for and during protocol therapy) medications that are potent inducers (rifampicin, rifabutin, phenytoin, carbamazepine, phenobarbital and St. John's Wort) of CYP3A4 function.
- Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 8 weeks after treatment discontinuation.
- Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy.
- Females must not be breastfeeding.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Komparátor placeba: Arm A: ZD6474 Matched Placebo
Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study.
Prophylactic antiemetics will be given at the discretion of the treating investigator.
|
Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
Matched placebo oral daily
|
Aktivní komparátor: Arm B: ZD6474
Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study.
Prophylactic antiemetics will be given at the discretion of the treating investigator.
|
Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
ZD6474 100mg oral daily to be continued for the duration of the study.
|
Experimentální: Safety Lead-In
Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study.
Prophylactic antiemetics will be given at the discretion of the treating investigator.
The safety lead-in will be conducted to determine the safety of the combination of ZD6474 and cisplation + etopiside.
If this combination is found to be unsafe, no patients will be randomized in the Phase II portion of the trial.
If the combination is deemed safe according to the protocol, participants from the safety lead-in cohort will not be included in the efficacy analysis.
|
Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles
Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles
ZD6474 100mg oral daily to be continued for the duration of the study.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Time to Disease Progression - Median Time to Progression and Log-Rank Test
Časové okno: 24 months
|
Kaplan-Meier analysis comparing arm A to arm B. Median time to progression and log-rank test.
Safety lead-in participants are not included in this analysis per protocol.
|
24 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Percentage of Participants With Grade 3/4 Hematologic and Non-Hematologic Toxicities
Časové okno: 6 weeks (2 Cycles)
|
Percentage of participants who experienced grade 3/4 hematologic and non-hematologic toxicities.
Participants from Arm A were compared to subjects from Arm B + Safety Lead-In.
|
6 weeks (2 Cycles)
|
Measure the Response Rate (CR + PR) in Each Arm
Časové okno: 24 months
|
Response assessments completed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST Therasse et al., 2000).
Complete Response (CR) is defined as: Disappearance of all target lesions.
Partial Response (PR) is defined as: >=30% decrease in the sum of the longest diameter of target lesions.
|
24 months
|
Measure Disease Control Rate (CR + PR+ SD) in Each Arm
Časové okno: 24 months
|
Response assessments completed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST Therasse et al., 2000).
Complete Response (CR) is defined as: Disappearance of all target lesions.
Partial Response (PR) is defined as: >=30% decrease in the sum of the longest diameter of target lesions.
Stable Disease (SD) is defined as: neither a partial response or progressive disease ( >=20% increase in the sum of the longest diameter of the target lesions).
|
24 months
|
Measure Overall Survival for Each Arm
Časové okno: 24 months
|
24 months
|
|
Assess VEGF Polymorphisms and Correlate Subject Response
Časové okno: 24 months
|
24 months
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Studijní židle: Nasser Hanna, M.D., Hoosier Oncology Group, Inc.
Publikace a užitečné odkazy
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Nemoci dýchacích cest
- Novotvary
- Plicní onemocnění
- Novotvary podle místa
- Novotvary dýchacího traktu
- Novotvary hrudníku
- Karcinom, Bronchogenní
- Bronchiální novotvary
- Novotvary plic
- Malobuněčný karcinom plic
- Molekulární mechanismy farmakologického působení
- Inhibitory enzymů
- Antineoplastická činidla
- Antineoplastické látky, fytogenní
- Inhibitory topoizomerázy II
- Inhibitory topoizomerázy
- Etoposid
Další identifikační čísla studie
- LUN06-113
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