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Gemcitabine, Capecitabine, and Oxaliplatin as Second-Line Therapy in Treating Patients With Advanced Colorectal Cancer Previously Treated With Irinotecan

20. august 2009 opdateret af: Yonsei University

A Phase I/II Study to Determine the Safety and Efficacy of Second-Line Treatment With XELOX Plus Gemcitabine in Irinotecan Pre-Treated Advanced Colorectal Cancer Patients

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, capecitabine, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of gemcitabine when given together with capecitabine and oxaliplatin as second-line therapy and to see how well it works in treating patients with advanced colorectal cancer previously treated with irinotecan.

Studieoversigt

Detaljeret beskrivelse

OBJECTIVES:

Primary

  • Define the dose-limiting toxicity and maximum tolerated dose of gemcitabine hydrochloride when administered with capecitabine and oxaliplatin as second-line therapy in patients with advanced colorectal cancer previously treated with irinotecan hydrochloride. (Phase I)
  • Determine the recommended phase II dose of gemcitabine hydrochloride in these patients. (Phase I)
  • Assess overall response rate in patients treated with this regimen. (Phase II)

Secondary

  • Assess the progression-free survival of patients treated with this regimen. (Phase II)
  • Assess the time to treatment failure, duration of response, and time to response in patients treated with this regimen. (Phase II)
  • Assess the overall survival of patients treated with this regimen. (Phase II)
  • Assess the safety of this regimen in these patients. (Phase II)

OUTLINE: This is a multicenter, phase I, dose-escalation study of gemcitabine hydrochloride, followed by a phase II, open-label study.

  • Phase I: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, oral capecitabine twice daily on days 1-14, and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days.

Cohorts of 3-6 patients receive escalating doses of gemcitabine hydrochloride until the maximum tolerated dose (MTD) is determined.

  • Phase II: Patients receive gemcitabine hydrochloride at the MTD determined in phase I and capecitabine and oxaliplatin as in phase I.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

56

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

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

Studiesteder

      • Seoul, Korea, Republikken, 120-752
        • Rekruttering
        • Yonsei Cancer Center at Yonsei University Medical Center
        • Kontakt:
          • Joong B. Ahn, MD
          • Telefonnummer: 82-2-2228-8134

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 advanced colorectal adenocarcinoma
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
  • Must have received prior irinotecan hydrochloride with a progression-free interval of < 3 months
  • No symptomatic brain metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 3 months
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9 g/dL
  • Total bilirubin ≤ 2 times upper limit of normal (ULN)
  • AST and ALT ≤ 3 times ULN (5 times ULN if liver metastases are present)
  • Creatinine ≤ 1.5 times ULN
  • No significant cardiac abnormalities by ECG
  • No known hypersensitivity to the study drugs or any of their components
  • No myocardial infarction within the past 12 months
  • No uncontrolled congestive heart failure
  • No cardiovascular disorder ≥ grade 3 despite treatment
  • No other malignancies or invasive carcinomas diagnosed within the past 5 years, except for adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix
  • No significant disease, that in the opinion of the investigator, would preclude study treatment (e.g., active infections, interstitial lung disease, or peripheral neuropathy)
  • No history of significant neurological or psychiatric disorder (e.g., dementia, seizures, or bipolar disorder)
  • No legal incapacity or limited legal capacity that would preclude study participation

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from all prior therapy
  • More than 30 days since prior participation in another clinical trial
  • No concurrent warfarin, phenprocoumon, phenytoin, or sorivudine

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
  • Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Overall response rate as assessed by RECIST criteria

Sekundære resultatmål

Resultatmål
Tid til behandlingssvigt
Progressionsfri overlevelse
Samlet overlevelse
Varighed af svar
Tid til at svare

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Joong B. Ahn, MD, Yonsei University

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. januar 2007

Primær færdiggørelse (Forventet)

1. august 2009

Datoer for studieregistrering

Først indsendt

3. juli 2007

Først indsendt, der opfyldte QC-kriterier

3. juli 2007

Først opslået (Skøn)

4. juli 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

21. august 2009

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. august 2009

Sidst verificeret

1. august 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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