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Sutent + Taxol for Advanced Esophageal Cancer

26 januari 2017 bijgewerkt door: Nasser Hanna, M.D., Hoosier Cancer Research Network

A Phase II Study of Sunitinib Malate (Sutent®) With Paclitaxel (Taxol®) in Patients With Advanced Esophageal Cancer

Paclitaxel is known to be active as a single and combination agent in esophageal cancer, and has also been demonstrated to have anti-angiogenic properties in weekly dosing regimens. Sunitinib malate is an anti-angiogenic drug with the potential to improve responses when combined with chemotherapy, as demonstrated with other regimens in similar settings. We believe that the combination of paclitaxel and sunitinib malate offer great promise in the treatment of advanced esophageal cancer.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Studietype

Ingrijpend

Inschrijving (Werkelijk)

28

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Illinois
      • Chicago, Illinois, Verenigde Staten, 60611
        • Northwestern University Feinberg School of Medicine
      • Chicago, Illinois, Verenigde Staten, 60612
        • Rush-Presbyterian St. Luke's Medical Center
      • Galesburg, Illinois, Verenigde Staten, 61401
        • Medical & Surgical Specialists, LLC
    • Indiana
      • Bloomington, Indiana, Verenigde Staten, 47403
        • Cancer Care Center of Southern Indiana
      • Evansville, Indiana, Verenigde Staten, 47714
        • Oncology Hematology Associates of SW Indiana
      • Fort Wayne, Indiana, Verenigde Staten, 46815
        • Fort Wayne Oncology & Hematology, Inc
      • Indianapolis, Indiana, Verenigde Staten, 46202
        • Indiana University Simon Cancer Center
      • Indianapolis, Indiana, Verenigde Staten, 46202
        • IN Onc/Hem Associates
      • Lafayette, Indiana, Verenigde Staten, 47905
        • Horizon Oncology Center
      • Lafayette, Indiana, Verenigde Staten, 47904
        • Arnett Cancer Care
      • Muncie, Indiana, Verenigde Staten, 47303
        • Medical Consultants, P.C.
      • Munster, Indiana, Verenigde Staten, 46321
        • Monroe Medical Associates
      • South Bend, Indiana, Verenigde Staten, 46601
        • Northern Indiana Cancer Research Consortium
      • Terre Haute, Indiana, Verenigde Staten, 47802
        • Providence Medical Group
    • Ohio
      • Cleveland, Ohio, Verenigde Staten, 44106
        • Ireland Cancer Center - University Hospitals of Cleveland

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.

  • 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.
Geneesmiddel: Sunitinib malate
Sunitinib malate 37.5 mg orally, daily
Geneesmiddel: Paclitaxel
Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Progression Free Survival Rate at 24 Weeks
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Response Rate
Tijdsspanne: 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
Tijdsspanne: 12 months
To determine the one year overall survival rate for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma
12 months
Progression-Free Survival
Tijdsspanne: 12 months
To determine the time to progression for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma per RECIST criteria.
12 months
Toxicity Profile
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hoosier Cancer Research Network

Medewerkers

Pfizer

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 augustus 2008

Primaire voltooiing (Werkelijk)

1 maart 2010

Studie voltooiing (Werkelijk)

1 maart 2010

Studieregistratiedata

Eerst ingediend

4 augustus 2008

Eerst ingediend dat voldeed aan de QC-criteria

6 augustus 2008

Eerst geplaatst (Schatting)

8 augustus 2008

Updates van studierecords

Laatste update geplaatst (Werkelijk)

16 maart 2017

Laatste update ingediend die voldeed aan QC-criteria

26 januari 2017

Laatst geverifieerd

1 januari 2017

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • HOG GI06-112

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

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