- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00033306
BMS-247550 in Treating Patients With Metastatic Colorectal Cancer
A Phase II Study Of Epothilone Analog BMS-247550 In Patients With Metastatic Colorectal Cancer Previously Treated With A Fluoropyrimidine And Irinotecan
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating patients who have metastatic colorectal cancer.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
OBJECTIVES:
- Determine the clinical activity of BMS-247550, as measured by the tumor response rate, in patients with metastatic colorectal cancer previously treated with a fluoropyrimidine and irinotecan.
- Determine the safety of this drug in these patients.
- Determine the response duration, time to progression, and survival in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive BMS-247550 IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive up to 4 additional courses of treatment beyond CR.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 19-55 patients will be accrued for this study within 6 months.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
Alabama
-
Birmingham, Alabama, Forente stater, 35294-3300
- University of Alabama at Birmingham Comprehensive Cancer Center
-
-
Georgia
-
Atlanta, Georgia, Forente stater, 30342
- Georgia Cancer Specialists
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed metastatic colorectal adenocarcinoma
Prior treatment for metastatic disease with at least:
- One regimen of irinotecan in combination with a fluoropyrimidine OR
Two regimens comprising fluoropyrimidine-based first-line therapy and irinotecan-based second-line therapy
- May have received cetuximab and/or a fluoropyrimidine as part of second- line therapy
- Disease progression during or within 4 months of treatment with irinotecan
- At least 1 bidimensionally measurable lesion
- No known CNS metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-1
Life expectancy:
- At least 12 weeks
Hematopoietic:
- Absolute neutrophil count at least 2,000/mm^3
- Platelet count greater than 125,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- ALT no greater than 2.5 times ULN (5 times ULN if hepatic metastases present)
Renal:
- Creatinine no greater than 1.5 times ULN
Cardiovascular:
- No New York Heart Association class III or IV heart disease
- No history of unstable angina, myocardial infarction, or congestive heart failure within the past 6 months
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No known prior severe hypersensitivity reactions to agents containing Cremophor EL
- No motor or sensory neuropathy grade 2 or greater
- No concurrent serious uncontrolled infection or other nonmalignant medical illness
- No concurrent psychiatric disorders or other conditions that would preclude study compliance
- No other active malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
- No concurrent immunotherapy
- No growth factors for 24 hours before and after cytotoxic chemotherapy
Chemotherapy:
- See Disease Characteristics
- Additional prior adjuvant or neoadjuvant chemotherapy allowed
- At least 4 weeks since prior chemotherapy and recovered
- No more than 2 prior regimens of cytotoxic chemotherapy for metastatic disease
- No prior oxaliplatin
- No other concurrent chemotherapy
Endocrine therapy:
- No concurrent hormonal therapy except hormone replacement therapy
Radiotherapy:
- At least 3 weeks since prior radiotherapy and recovered
- No prior radiotherapy to target lesion unless the lesion has shown progression after completion of radiotherapy
No concurrent therapeutic radiotherapy
- Focal radiotherapy for palliation of bone symptoms may be allowed
Surgery:
- At least 1 week since prior minor surgery (3 weeks for major surgery) and recovered
Other:
- No other concurrent experimental anticancer medications
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: BMS-247550
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Determine the clinical activity of BMS-247550, as measured by the tumor response rate, in patients with metastatic colorectal cancer previously treated with a fluoropyrimidine and irinotecan.
Tidsramme: baseline to survival
|
baseline to survival
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Determine the safety of this drug in these patients.
Tidsramme: baseline to survival
|
baseline to survival
|
Determine the response duration, time to progression, and survival in patients treated with this drug.
Tidsramme: baseline to survival
|
baseline to survival
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Studiestol: Andres Forero-Torres, MD, CSU, University of Alabama at Birmingham
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Neoplasmer
- Neoplasmer etter nettsted
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Kolonsykdommer
- Tarmsykdommer
- Intestinale neoplasmer
- Rektale sykdommer
- Kolorektale neoplasmer
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Antineoplastiske midler
- Topoisomerasehemmere
- Topoisomerase I-hemmere
- Irinotekan
Andre studie-ID-numre
- CDR0000069272
- UAB-0145
- BMS-CA163-012
- UAB-F011029021
- NCI-G02-2051
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