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Capecitabine and Irinotecan in Treating Patients With Locally Advanced, Recurrent, or Metastatic Colorectal Cancer

16 mars 2016 uppdaterad av: Hoffmann-La Roche

A Phase II Study of Oral Xeloda (Capecitabine) in Combination With Intravenous Irinotecan for Patients With Locally Advanced and/or Metastatic Colorectal Cancer

PURPOSE: Phase II trial to study the effectiveness of combining capecitabine and irinotecan in treating patients who have locally advanced, recurrent, or metastatic colorectal cancer.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

OBJECTIVES:

Primary:

  • Determine the overall objective response rate in patients with locally advanced, locally recurrent, or metastatic colorectal cancer treated with capecitabine and irinotecan.

Secondary:

  • Determine the time to treatment failure, time to overall response, duration of overall response, duration of overall complete response, and time to progression in patients treated with this regimen.
  • Determine the 1-year survival and overall survival of patients treated with this regimen.
  • Determine the toxicity and safety profile of this regimen in these patients.
  • Determine the feasibility of predicting responses to this regimen by the molecular profile of tumor tissue in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral capecitabine twice daily on days 2-15 and irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Patients maintaining a response or stable disease after 12 courses may continue treatment at the discretion of the investigator.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 9 months.

Studietyp

Interventionell

Inskrivning (Faktisk)

67

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Alabama
      • Birmingham, Alabama, Förenta staterna, 35294-3300
        • University of Alabama at Birmingham Comprehensive Cancer Center
    • California
      • Loma Linda, California, Förenta staterna, 92354
        • Loma Linda University Cancer Institute at Loma Linda University Medical Center
    • Connecticut
      • Norwich, Connecticut, Förenta staterna, 06360
        • Eastern Connecticut Hematology and Oncology Associates
    • District of Columbia
      • Washington, District of Columbia, Förenta staterna, 20007
        • Lombardi Cancer Center at Georgetown University Medical Center
      • Washington, District of Columbia, Förenta staterna, 20037
        • George Washington University Medical Center
    • Florida
      • Jacksonville, Florida, Förenta staterna, 32209
        • University of Florida Health Science Center - Jacksonville
    • Kentucky
      • Lexington, Kentucky, Förenta staterna, 40536-0084
        • Markey Cancer Center at University of Kentucky Chandler Medical Center
    • Missouri
      • Saint Louis, Missouri, Förenta staterna, 63110-0250
        • St. Louis University Hospital Cancer Center
    • New York
      • Bronx, New York, Förenta staterna, 10451
        • Lincoln Medical and Mental Health Center
      • Brooklyn, New York, Förenta staterna, 11235
        • HemOnCare, P.C.
    • Pennsylvania
      • Philadelphia, Pennsylvania, Förenta staterna, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, Förenta staterna, 19107-5541
        • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
    • South Carolina
      • Charleston, South Carolina, Förenta staterna, 29403
        • Charleston Hematology-Oncology, P.A.
    • Virginia
      • Charlottesville, Virginia, Förenta staterna, 22908
        • Cancer Center at the University of Virginia
    • Washington
      • Seattle, Washington, Förenta staterna, 98104
        • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
      • Spokane, Washington, Förenta staterna, 99202
        • Rockwood Clinic P.S.
    • West Virginia
      • Morgantown, West Virginia, Förenta staterna, 26506-9300
        • West Virginia University Hospitals

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

DISEASE CHARACTERISTICS:

  • Histologically confirmed locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma

  • At least 1 measurable lesion

    • At least 10 mm by spiral CT scan
    • At least 20 mm by conventional techniques
    • Bone metastases, ascites, or pleural effusions are not considered measurable disease
  • No evidence of CNS metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 80-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • Neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.25 times upper limit of normal (ULN)
  • ALT and AST no greater than 2.5 times ULN (5 times ULN if liver metastases present)
  • Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN if liver metastases present or 10 times ULN if bone metastases present)
  • No known Gilbert's disease

Renal:

  • Creatinine no greater than 1.5 times ULN
  • Creatinine clearance at least 50 mL/min

Cardiovascular:

  • No clinically significant cardiac disease
  • No congestive heart failure
  • No symptomatic coronary artery disease
  • No cardiac arrhythmias uncontrolled with medication
  • No myocardial infarction within the past 12 months

Gastrointestinal:

  • Able to swallow tablets
  • No lack of physical integrity of the upper gastrointestinal tract
  • No malabsorption syndrome

Other:

  • No prior unanticipated severe reaction to fluoropyrimidine therapy
  • No hypersensitivity to fluorouracil
  • No history of uncontrolled seizures or CNS disorders
  • No psychological illness or condition that would preclude study entry
  • No other malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix
  • No serious infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 12 months since prior neoadjuvant or adjuvant, active or passive immunotherapy
  • No concurrent active or passive immunotherapy (e.g., 17-1A antibody) for colon cancer
  • No concurrent prophylactic hematopoietic growth factors

Chemotherapy:

  • At least 12 months since prior neoadjuvant or adjuvant cytotoxic chemotherapy
  • No prior chemotherapy for metastatic colorectal cancer
  • No prior therapy with irinotecan or capecitabine
  • No other concurrent cytotoxic agents

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 4 weeks since prior radiotherapy
  • No prior radiotherapy to measurable lesion (newly arising lesions in a previously irradiated area allowed)
  • No concurrent radiotherapy

Surgery:

  • At least 4 weeks since prior major surgery and recovered
  • No prior organ allograft

Other:

  • At least 4 weeks since prior participation in an investigational drug study
  • No other concurrent investigational drugs

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Cohort 1,Initial Regimen:(Capecitabine + Irinotecan )
Participants will receive capecitabine (Xeloda) 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute intravenous (IV) infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment will be administered. At the discretion of the investigator, participants who are responding or whose disease is stable will be permitted to continue capecitabine/irinotecan combination therapy until progressive disease is documented in the post-study treatment phase. Participants not participating in post-study treatment will be followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
Läkemedel: Capecitabin
Läkemedel: Irinotekan
Experimentell: Cohort 2,Amended Regimen:(Capecitabine + Irinotecan)
Participants will receive capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute intravenous (IV) infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment will be administered. At the discretion of the investigator, participants who will be responding or whose disease is stable will be permitted to continue capecitabine/irinotecan combination therapy until progressive disease is documented in the post-study treatment phase. Participants not participating in post-study treatment will be followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
Läkemedel: Capecitabin
Läkemedel: Irinotekan

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Tumor Response Rate Based on Tumor Measurement as Per Response Evaluation Criteria In Solid Tumors Version 1.0 (RECIST 1.0)
Tidsram: Approximately 43 Months
Objective Response Rate (ORR) is defined as the percentage of participants with complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST 1.0). CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level. PR is defined as a greater than or equal to (>/=) 30% decrease in the sum of the longest diameter (LD) of the target lesions, taking as reference the baseline sum of LD. Participants who did not have a post-baseline tumor measurement were considered non-responders in the assessment of ORR.
Approximately 43 Months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Time to Disease Progression
Tidsram: Approximately 43 Months
Time to disease progression was assessed as the time from start of treatment to the time the participant was first recorded as having disease progression or died due to causes other than disease progression. If a participant never progressed while being followed, he/she was censored at the date of the last tumor assessment or the date of the last dose if no post-baseline tumor measurement was available.
Approximately 43 Months
Time to Treatment Failure
Tidsram: Approximately 43 Months
Time to treatment failure was assessed as the time from start of treatment to the time the participant was withdrawn due to any of the reasons such as adverse events, progressive disease, insufficient therapeutic response, death, failure to return, or refused treatment, did not cooperate or withdrew consent.
Approximately 43 Months
Percentage of Participants With One-year Survival
Tidsram: Up to Month 12
Survival was measured as the time from start of treatment to the date of death or till one year whichever occurred first.
Up to Month 12
Overall Survival
Tidsram: Approximately 43 Months
Overall Survival is defined as the time from start of treatment to the date of death. Participants who did not die were censored at the last date the participant was known to be alive.
Approximately 43 Months
Time To Objective Response
Tidsram: Approximately 43 Months
The time to objective response is defined as the time from start of treatment to the date of first objective response. Participants who never responded during study were censored at the last tumor assessment or the date of last dose, whichever was later, or at the date of death if occurring prior to response.
Approximately 43 Months
Duration of Overall Response
Tidsram: Approximately 43 Months
Duration of overall response was assessed from the time that measurement criteria were first met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease was documented. It was analyzed for responders only. Participants without observed progressive disease after an objective response were censored at the date of the last tumor assessment.
Approximately 43 Months
Duration of Overall Complete Response
Tidsram: Approximately 43 Months
The duration of overall complete response was assessed from the time that measurement criteria were met for complete response until the first date that recurrent or progressive disease was objectively documented. Participants without observed progressive disease after an objective complete response were censored at the date of the last tumor assessment.
Approximately 43 Months
Number of Participants With Any Adverse Events, Serious Adverse Events and Deaths
Tidsram: Approximately 43 Months
An adverse event (AEs) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. A serious adverse event is defined as any event which was fatal (resulted in death), life-threatening (with immediate risk of death), resulted in a new or prolongation of a current hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly or birth defect, considered medically significant by the investigator, required intervention to prevent one or more of the outcomes listed above.
Approximately 43 Months

Samarbetspartners och utredare

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Sponsor

Hoffmann-La Roche

Publikationer och användbara länkar

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Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 maj 2001

Primärt slutförande (Faktisk)

1 december 2004

Avslutad studie (Faktisk)

1 december 2004

Studieregistreringsdatum

Först inskickad

10 augusti 2001

Först inskickad som uppfyllde QC-kriterierna

26 januari 2003

Första postat (Uppskatta)

27 januari 2003

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

15 april 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

16 mars 2016

Senast verifierad

1 februari 2005

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • ML16323

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