- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00022698
Capecitabine and Irinotecan in Treating Patients With Locally Advanced, Recurrent, or Metastatic Colorectal Cancer
A Phase II Study of Oral Xeloda (Capecitabine) in Combination With Intravenous Irinotecan for Patients With Locally Advanced and/or Metastatic Colorectal Cancer
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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Alabama
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Birmingham, Alabama, Vereinigte Staaten, 35294-3300
- University of Alabama at Birmingham Comprehensive Cancer Center
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California
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Loma Linda, California, Vereinigte Staaten, 92354
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
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Connecticut
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Norwich, Connecticut, Vereinigte Staaten, 06360
- Eastern Connecticut Hematology and Oncology Associates
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District of Columbia
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Washington, District of Columbia, Vereinigte Staaten, 20007
- Lombardi Cancer Center at Georgetown University Medical Center
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Washington, District of Columbia, Vereinigte Staaten, 20037
- George Washington University Medical Center
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Florida
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Jacksonville, Florida, Vereinigte Staaten, 32209
- University of Florida Health Science Center - Jacksonville
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Kentucky
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Lexington, Kentucky, Vereinigte Staaten, 40536-0084
- Markey Cancer Center at University of Kentucky Chandler Medical Center
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Missouri
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Saint Louis, Missouri, Vereinigte Staaten, 63110-0250
- St. Louis University Hospital Cancer Center
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New York
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Bronx, New York, Vereinigte Staaten, 10451
- Lincoln Medical and Mental Health Center
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Brooklyn, New York, Vereinigte Staaten, 11235
- HemOnCare, P.C.
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Pennsylvania
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19111
- Fox Chase Cancer Center
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19107-5541
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
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South Carolina
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Charleston, South Carolina, Vereinigte Staaten, 29403
- Charleston Hematology-Oncology, P.A.
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Virginia
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Charlottesville, Virginia, Vereinigte Staaten, 22908
- Cancer Center at the University of Virginia
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Washington
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Seattle, Washington, Vereinigte Staaten, 98104
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
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Spokane, Washington, Vereinigte Staaten, 99202
- Rockwood Clinic P.S.
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West Virginia
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Morgantown, West Virginia, Vereinigte Staaten, 26506-9300
- West Virginia University Hospitals
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 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).
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Experimental: 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).
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Tumor Response Rate Based on Tumor Measurement as Per Response Evaluation Criteria In Solid Tumors Version 1.0 (RECIST 1.0)
Zeitfenster: 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.
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Approximately 43 Months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Time to Disease Progression
Zeitfenster: 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.
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Approximately 43 Months
|
Time to Treatment Failure
Zeitfenster: 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.
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Approximately 43 Months
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Percentage of Participants With One-year Survival
Zeitfenster: Up to Month 12
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Survival was measured as the time from start of treatment to the date of death or till one year whichever occurred first.
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Up to Month 12
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Overall Survival
Zeitfenster: Approximately 43 Months
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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.
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Approximately 43 Months
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Time To Objective Response
Zeitfenster: Approximately 43 Months
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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.
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Approximately 43 Months
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Duration of Overall Response
Zeitfenster: Approximately 43 Months
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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.
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Approximately 43 Months
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Duration of Overall Complete Response
Zeitfenster: Approximately 43 Months
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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.
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Approximately 43 Months
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Number of Participants With Any Adverse Events, Serious Adverse Events and Deaths
Zeitfenster: 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.
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Approximately 43 Months
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Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Meropol NJ, Gold PJ, Diasio RB, Andria M, Dhami M, Godfrey T, Kovatich AJ, Lund KA, Mitchell E, Schwarting R. Thymidine phosphorylase expression is associated with response to capecitabine plus irinotecan in patients with metastatic colorectal cancer. J Clin Oncol. 2006 Sep 1;24(25):4069-77. doi: 10.1200/JCO.2005.05.2084.
- Carlini LE, Meropol NJ, Bever J, Andria ML, Hill T, Gold P, Rogatko A, Wang H, Blanchard RL. UGT1A7 and UGT1A9 polymorphisms predict response and toxicity in colorectal cancer patients treated with capecitabine/irinotecan. Clin Cancer Res. 2005 Feb 1;11(3):1226-36.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Verdauungssystems
- Neubildungen
- Neubildungen nach Standort
- Gastrointestinale Neubildungen
- Neoplasmen des Verdauungssystems
- Magen-Darm-Erkrankungen
- Darmerkrankungen
- Darmerkrankungen
- Darmtumoren
- Rektale Erkrankungen
- Kolorektale Neubildungen
- Molekulare Mechanismen der pharmakologischen Wirkung
- Enzym-Inhibitoren
- Antimetaboliten, antineoplastisch
- Antimetaboliten
- Antineoplastische Mittel
- Topoisomerase-Inhibitoren
- Topoisomerase I-Inhibitoren
- Capecitabin
- Irinotecan
Andere Studien-ID-Nummern
- ML16323
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