- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00730353
Sutent + Taxol for Advanced Esophageal Cancer
A Phase II Study of Sunitinib Malate (Sutent®) With Paclitaxel (Taxol®) in Patients With Advanced Esophageal Cancer
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
OUTLINE: This is a multi-center study.
Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.
- Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.
- Sunitinib malate 37.5 mg orally, daily.
After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion.
Performance Status: ECOG (Eastern Cooperative Oncology Group) performance status 0 to 2
Life expectancy: Not specified
Hematopoietic:
- International Normalized Ratio (INR) < 1.2
- Partial Thromboplastin Time (PTT) < 1.5 x Upper Limit of Normal (ULN)
- Platelets > 100 K/mm3
- Hemoglobin > 8 g/dL
- Absolute Neutrophil Count (ANC) > 1.0 K/mm3
Hepatic:
- Aspartate transaminase (AST) ≤ 2.5 x ULN, or ≤ 5.0 x ULN if the transaminase elevation is due to known liver metastases.
- Alanine transaminase (ALT) ≤ 2.5 x ULN, or ≤ 5.0 x ULN if the transaminase elevation is due to known liver metastases.
- Total bilirubin < 2.0 x ULN
Renal:
- Serum creatinine ≤ 2 x ULN or a calculated creatinine clearance (using Cockcroft-Gault formula) > 50 cc/min
Cardiovascular:
- No history of unstable angina, myocardial infarction, coronary artery bypass grafting surgery within 12 months prior to registration for protocol therapy. Patients may be on anti-anginal medications, but must be stable on those medications for at least 6 months.
- No history of New York Heart Association class II or greater congestive heart failure.
Pulmonary:
- Not specified
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
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Illinois
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Chicago, Illinois, Förenta staterna, 60611
- Northwestern University Feinberg School of Medicine
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Chicago, Illinois, Förenta staterna, 60612
- Rush-Presbyterian St. Luke's Medical Center
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Galesburg, Illinois, Förenta staterna, 61401
- Medical & Surgical Specialists, LLC
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Indiana
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Bloomington, Indiana, Förenta staterna, 47403
- Cancer Care Center of Southern Indiana
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Evansville, Indiana, Förenta staterna, 47714
- Oncology Hematology Associates of SW Indiana
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Fort Wayne, Indiana, Förenta staterna, 46815
- Fort Wayne Oncology & Hematology, Inc
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Indianapolis, Indiana, Förenta staterna, 46202
- Indiana University Simon Cancer Center
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Indianapolis, Indiana, Förenta staterna, 46202
- IN Onc/Hem Associates
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Lafayette, Indiana, Förenta staterna, 47905
- Horizon Oncology Center
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Lafayette, Indiana, Förenta staterna, 47904
- Arnett Cancer Care
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Muncie, Indiana, Förenta staterna, 47303
- Medical Consultants, P.C.
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Munster, Indiana, Förenta staterna, 46321
- Monroe Medical Associates
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South Bend, Indiana, Förenta staterna, 46601
- Northern Indiana Cancer Research Consortium
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Terre Haute, Indiana, Förenta staterna, 47802
- Providence Medical Group
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Ohio
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Cleveland, Ohio, Förenta staterna, 44106
- Ireland Cancer Center - University Hospitals of Cleveland
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Histologically confirmed recurrent or metastatic esophageal or gastro-esophageal junction squamous cell or adenocarcinoma
- Measurable or evaluable disease per RECIST within 28 days prior to being registered on protocol therapy.
- No more than one prior chemotherapy regimen for locally advanced or metastatic disease is allowed.
- Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age > 18 years.
- Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) while on treatment and for 3 month period thereafter.
- Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy. Subjects are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
- Females must not be breastfeeding.
- Must be willing to comply with study and follow up procedures.
Exclusion Criteria:
- No history of inadequately controlled hypertension (Systolic Blood Pressure > 150 or Diastolic Blood Pressure > 100) on a standard regimen of antihypertensive therapy.
- No prior treatment with vascular endothelial growth factor (VEGF) inhibitor, epidermal growth factor receptor (EGFR) inhibitor, or other anti-angiogenic agent.
No serious, non-healing wound, ulcer, or bone fracture.
- No history of or current hemoptysis.
- No history of transient ischemic attack (TIA) or stroke within 12 months prior to registration for protocol therapy.
- No evidence of bleeding diathesis, coagulopathy, prolonged INR or PTT.
- No chronic anti-coagulation treatment.
- No history of central nervous system or brain metastases.
- No history of any major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration for protocol therapy, or anticipation of need for major surgical procedure during the course of protocol therapy.
- No history of any minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to registration for protocol therapy.
- No history of clinically significant peripheral neuropathy, i.e., Grade > 3 neuromotor or neurosensory toxicity as defined by NCI CTCAE v 3.0.
- No known history of adrenal insufficiency documented by adrenocorticotropic hormone (ACTH) stimulation testing.
- No prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (> 450 msec), obtained within 28 days prior to being registered for protocol therapy.
- No other active cancers
- No clinically significant infections as judged by the treating investigator.
- No history of a seizure disorder.
- No known history of hypersensitivity to paclitaxel.
- No CYP3A4 inducers and inhibitors allowed within 14 days prior to registration on protocol therapy and while receiving the protocol therapy.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 1
Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.
|
Sunitinib malate 37.5 mg orally, daily
Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Progression Free Survival Rate at 24 Weeks
Tidsram: 24 weeks
|
To determine the rate of non-progressive disease at 24 weeks from the first dose of the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma, where progression is defined as 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
|
24 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Response Rate
Tidsram: 6 months
|
To determine the response rate for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma per RECIST criteria.
|
6 months
|
Overall Survival
Tidsram: 12 months
|
To determine the one year overall survival rate for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma
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12 months
|
Progression-Free Survival
Tidsram: 12 months
|
To determine the time to progression for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma per RECIST criteria.
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12 months
|
Toxicity Profile
Tidsram: 16 months
|
Determine the most frequent toxicities associated with the treatment regimen, per the CTCAE version 3 (Common Toxicity Criteria for Adverse Events) criteria.
|
16 months
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Neoplasmer
- Neoplasmer efter plats
- Gastrointestinala neoplasmer
- Neoplasmer i matsmältningssystemet
- Gastrointestinala sjukdomar
- Neoplasmer i huvud och hals
- Esofagussjukdomar
- Esofagusneoplasmer
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Enzyminhibitorer
- Antineoplastiska medel
- Tubulin modulatorer
- Antimitotiska medel
- Mitosmodulatorer
- Antineoplastiska medel, fytogena
- Angiogeneshämmare
- Angiogenesmodulerande medel
- Tillväxtämnen
- Tillväxthämmare
- Proteinkinashämmare
- Paklitaxel
- Sunitinib
Andra studie-ID-nummer
- HOG GI06-112
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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Kliniska prövningar på Matstrupscancer
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