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SU5416 in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer

31. maj 2013 opdateret af: National Cancer Institute (NCI)

Phase II Trial of SU5416 (NSC #696819) in Patients With Advanced Colorectal Cancer

Phase II trial to study the effectiveness of SU5416 in treating patients who have metastatic or locally recurrent colorectal cancer. SU5416 may stop the growth of colorectal cancer by stopping blood flow to the tumor.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

I. Determine the objective response rate and disease stabilization rates of patients with previously treated metastatic or locally recurrent colorectal cancer treated with SU5416.

II. Determine the median and overall survival and time to progression in this patient population receiving this treatment.

III. Determine the toxicity of SU5416 in these patients.

OUTLINE: This is a multicenter study.

Patient receive SU5416 IV over 60 minutes twice weekly for 4 weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression.

Patients are followed every 2 weeks for 4 weeks.

PROJECTED ACCRUAL: A total of 17-37 patients will be accrued for this study within 12-18 months.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

37

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • University of Illinois at Chicago
      • Chicago, Illinois, Forenede Stater, 60640
        • Louis A. Weiss Memorial Hospital
      • Chicago, Illinois, Forenede Stater, 60637
        • University of Chicago Cancer Research Center
      • Decatur, Illinois, Forenede Stater, 62526
        • Cancer Care Specialists of Central Illinois, S.C.
      • Evanston, Illinois, Forenede Stater, 60201
        • Evanston Northwestern Health Care
      • Park Ridge, Illinois, Forenede Stater, 60068
        • Division of Hematology/Oncology
      • Peoria, Illinois, Forenede Stater, 61602
        • Oncology/Hematology Associates of Central Illinois, P.C.
      • Springfield, Illinois, Forenede Stater, 62701
        • Central Illinois Hematology Oncology Center
    • Indiana
      • Fort Wayne, Indiana, Forenede Stater, 46885-5099
        • Fort Wayne Medical Oncology and Hematology, Inc.
      • South Bend, Indiana, Forenede Stater, 46617
        • Michiana Hematology/Oncology P.C.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Histologically confirmed metastatic or locally recurrent adenocarcinoma of the colon or rectum
  • Progressive disease as defined by new or progressive radiologic lesions
  • Measurable disease at least 1 dimension as at least 20 mm with conventional techniques or at least 10 mm with spiral CT scan
  • Lesions seen on colonoscopic examination or barium studies, bone metastases, CNS lesions, CEA levels and ascites are not considered measurable
  • Lesion accessible for biopsy which is not within prior radiation port
  • Known history of CNS metastasis allowed if patients have had treatment, are neurologically stable, and do not require oral or intravenous steroids or anticonvulsants, provided brain scan (CT or MRI) shows absence of active or residual disease
  • If neurologic signs or symptoms suggestive of CNS metastasis, negative brain scan required

PATIENT CHARACTERISTICS:

  • Age: 18 and over
  • Performance status: WHO 0-2
  • Life expectancy: At least 12 weeks
  • WBC at least 3,000/mm3
  • Platelet count at least 75,000/mm3
  • Bilirubin no greater than 1.5 mg/dL
  • Transaminases no greater than 2.5 times upper limit of normal
  • Creatinine no greater than 1.5 mg/dL OR creatinine clearance at least 60 mL/min
  • No uncompensated coronary artery disease
  • No history of myocardial infarction or severe/unstable angina within past 6 months
  • No severe peripheral vascular disease associated with diabetes mellitus
  • No deep venous or arterial thrombosis within past 3 months
  • No pulmonary embolism within past 3 months
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other significant uncontrolled underlying medical or psychiatric illness
  • No serious active infections
  • No concurrent second malignancy except for nonmelanoma skin cancer or carcinoma in situ of the cervix unless completed therapy and considered to be at less than 30% risk of relapse
  • No history of severe allergic or anaphylactic reactions to paclitaxel or docetaxel

PRIOR CONCURRENT THERAPY:

  • No more than 2 prior chemotherapy regimens for metastatic disease
  • At least 4 weeks since prior chemotherapy
  • No concurrent chemotherapy
  • No other concurrent investigational antineoplastic drugs
  • No prior radiotherapy to only site of measurable disease
  • At least 4 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy
  • At least 30 days since other prior investigational drugs

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm I
Patient receive SU5416 IV over 60 minutes twice weekly for 4 weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2000

Primær færdiggørelse (Faktiske)

1. februar 2007

Studieafslutning (Faktiske)

1. august 2009

Datoer for studieregistrering

Først indsendt

5. juli 2000

Først indsendt, der opfyldte QC-kriterier

25. maj 2004

Først opslået (Skøn)

26. maj 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

3. juni 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. maj 2013

Sidst verificeret

1. februar 2009

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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