- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00401128
Gemcitabine and Irinotecan in Treating Patients With Metastatic Kidney Cancer
Phase II Study of Gemcitabine Plus Irinotecan in Patients With Metastatic Renal Cell Carcinoma
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, 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 II trial is studying the side effects and how well giving gemcitabine together with irinotecan works in treating patients with metastatic kidney cancer.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES:
- Determine the response rate in patients with epithelial (clear or nonclear cell) renal cell carcinoma (RCC) treated with gemcitabine hydrochloride and irinotecan hydrochloride.
- Compare the response in patients with clear cell RCC vs nonclear cell RCC treated with this regimen.
- Determine the toxicities of this regimen.
OUTLINE: This is an open-label study.
Patients receive gemcitabine hydrochloride IV over 30 minutes and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for at least 6 courses in the absence of unacceptable toxicity or disease progression.
After completion of study treatment, patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Ohio
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Cleveland, Ohio, Forenede Stater, 44106-5065
- Case Comprehensive Cancer Center
-
-
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 epithelial renal cell carcinoma (RCC), including either clear cell or nonclear cell RCC
- Strong clinical evidence or biopsy proof of metastases to a site or sites distant from the primary tumor
- Measurable disease
- No untreated or progressive CNS metastases
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy > 3 months
- Absolute neutrophil count > 1,500/mm³
- Platelet count > 100,000/mm³
- Hemoglobin > 9.5 g/dL
- Creatinine ≤ 1.8 mg/dL
- Bilirubin < 1.5 mg/dL
- Calcium < 11.5 mg/dL
- ALT and AST < 3 times upper limit of normal
No history of any of the following:
- Serious cardiac arrhythmia or cardiac arrhythmia requiring treatment
- Congestive heart failure
- Angina pectoris
- Other severe cardiovascular disease producing limitations of physical activity (i.e., New York Heart Association class III-IV heart disease)
No other prior malignancy except for the following:
- Basal cell or squamous cell carcinoma of the skin
- Carcinoma in situ of the uterine cervix
- Any malignancy treated with curative intent and in complete remission for > 3 years
- No active peptic ulcer disease, inflammatory bowel disease, or chronic diarrhea
- No local or systemic infections requiring IV antibiotics within the past 28 days
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- Recovered from prior hormonal therapy, radiotherapy, biologic therapy, or chemotherapy
- No more than 3 prior therapeutic regimens for metastatic disease
- No prior organ allograft
- More than 28 days since prior major surgery requiring general anesthesia
- More than 28 days since prior radiotherapy to control pain from skeletal lesions
- More than 28 days since prior hormonal treatment
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
---|
Sikkerhed og effektivitet
|
Samlet respons
|
Sekundære resultatmål
Resultatmål |
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Difference in response to therapy in patients with clear vs nonclear cell renal cell carcinoma
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neoplasmer efter histologisk type
- Neoplasmer
- Urologiske neoplasmer
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Nyresygdomme
- Urologiske sygdomme
- Adenocarcinom
- Karcinom
- Neoplasmer, kirtel og epitel
- Nyre-neoplasmer
- Karcinom, nyrecelle
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Antivirale midler
- Enzymhæmmere
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Topoisomerasehæmmere
- Topoisomerase I-hæmmere
- Gemcitabin
- Irinotecan
Andre undersøgelses-id-numre
- CASE-CCF-6695
- P30CA043703 (U.S. NIH-bevilling/kontrakt)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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-
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