- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00107315
Bevacizumab and Capecitabine as First-Line Therapy in Treating Older Patients With Metastatic Colorectal Cancer
A Phase II Study of Capecitabine and Bevacizumab in Elderly Patients With Metastatic Colorectal Cancer
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with capecitabine may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with capecitabine works as first-line therapy in treating older patients with metastatic colorectal cancer.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES:
Primary
- Determine the time to disease progression in older patients with metastatic colorectal cancer treated with bevacizumab and capecitabine as first-line therapy.
Secondary
- Determine the response rate in patients treated with this regimen.
- Determine the median survival of patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
OUTLINE: This is an open-label study.
Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral capecitabine twice daily on days 1-7. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 13-16 months.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
New York
-
Buffalo, New York, Forenede Stater, 14263-0001
- Roswell Park Cancer Institute
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
DISEASE CHARACTERISTICS:
Histologically* or cytologically* confirmed colorectal cancer
- Site of primary tumor must have been confirmed by endoscopy, radiography, or surgery
- Metastatic disease NOTE: *Patients with a history of surgically treated colorectal cancer who subsequently develop recurrent metastatic disease do not require histologic or cytologic confirmation of metastatic disease unless an interval of > 5 years has elapsed between initial primary surgery and the development of metastases
Measurable disease
- At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- No known curative therapy exists
- No history or evidence of CNS disease by physical exam (e.g., primary brain tumor or brain or CNS metastases)
PATIENT CHARACTERISTICS:
Age
- 70 and over
Performance status
- ECOG 0-1
Life expectancy
- More than 3 months
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9 g/dL
- No bleeding diathesis or coagulopathy
Hepatic
- Bilirubin normal
- AST and ALT ≤ 3 times upper limit of normal (ULN)
- INR < 1.5 (unless on therapeutic anticoagulants)
- No unstable or uncompensated hepatic disease
Renal
- Creatinine < 1.2 times ULN OR
- Creatinine clearance > 60 mL/min
- No unstable or uncompensated renal disease
Cardiovascular
- No history of stroke
- No uncontrolled hypertension (i.e., blood pressure > 150/100 mm Hg on medication)
- No myocardial infarction within the past year
- No New York Heart Association class II-IV congestive heart failure
- No unstable angina
- No serious cardiac dysrhythmia requiring medication
- No other clinically significant cardiovascular disease
- No other unstable or uncompensated cardiac disease
Pulmonary
- No unstable or uncompensated respiratory disease
Other
- Fertile patients must use effective contraception
- Able to receive oral medication
- No known hypersensitivity to fluorouracil or capecitabine
- No known dihydropyrimidine dehydrogenase deficiency
- No seizures not controlled by standard medical therapy
- No serious nonhealing wound, ulcer, or bone fracture
- No other malignancy within the past 5 years except completely excised nonmelanoma skin cancer (with no evidence of recurrent disease) or carcinoma in situ of the cervix
- No other severe or uncontrolled systemic disease
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior bevacizumab
Chemotherapy
- Prior adjuvant fluorouracil and leucovorin calcium allowed provided the last treatment was administered > 6 months before the development of metastatic disease
- No prior chemotherapy for metastatic colon cancer
- No prior irinotecan or oxaliplatin
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- See Disease Characteristics
- More than 28 days since prior and no concurrent major surgery
- More than 28 days since prior open biopsy
- More than 7 days since prior fine needle aspiration or core biopsy
Other
- More than 4 weeks since prior and no concurrent participation in another experimental drug study
- More than 30 days since prior non-approved or investigational drugs
Studieplan
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 1
Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral capecitabine twice daily on days 1-7
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Time to Progression
Tidsramme: 1 year
|
1 year
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Response Rate
Tidsramme: 1 year
|
Overall Response (OR) = CR + PR.
|
1 year
|
Median Survival
Tidsramme: 1 year
|
1 year
|
|
Toxicity
Tidsramme: 1 year
|
Number of participants with an adverse event. Please refer to the adverse event reporting for more detail. |
1 year
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Marwan Fakih, MD, Roswell Park Cancer Institute
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer
- Neoplasmer efter sted
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Gastrointestinale sygdomme
- Tyktarmssygdomme
- Tarmsygdomme
- Intestinale neoplasmer
- Endetarmssygdomme
- Kolorektale neoplasmer
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Antineoplastiske midler, immunologiske
- Angiogenese-hæmmere
- Angiogenesemodulerende midler
- Vækststoffer
- Væksthæmmere
- Capecitabin
- Bevacizumab
Andre undersøgelses-id-numre
- I 22204
- RPCI-I-22204
- GENENTECH-RPCI-I-22204
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