- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00072267
UCN-01 and Topotecan in Treating Patients With Recurrent, Persistent, or Progressive Advanced Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
A Phase II Study of UCN-01 in Combination With Topotecan in Patients With Advanced Ovarian Cancer
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining UCN-01 with topotecan may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining UCN-01 with topotecan in treating patients who have recurrent, persistent, or progressive advanced ovarian epithelial, primary peritoneal, or fallopian tube cancer.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
OBJECTIVES:
Primary
- Determine the antitumor activity of UCN-01 and topotecan, in terms of complete and partial objective response rates, in patients with recurrent, persistent, or progressive advanced ovarian epithelial, primary peritoneal, or fallopian tube cancer.
Secondary
- Determine the antitumor activity of this regimen, in terms of stable disease rates and duration of response, in these patients.
- Determine the progression-free, median, and overall survival of patients treated with this regimen.
- Determine the safety and tolerability of this regimen in these patients.
- Determine the relationship between clinical and pharmacodynamic effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive UCN-01 IV over 3 hours on day 1 and topotecan IV over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 19-33 patients will be accrued for this study within 5-11 months.
Studietype
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
Ontario
-
Hamilton, Ontario, Canada, L8V 5C2
- Margaret and Charles Juravinski Cancer Centre
-
London, Ontario, Canada, N6A 4L6
- Cancer Care Ontario-London Regional Cancer Centre
-
Ottawa, Ontario, Canada, K1H 8L6
- Ottawa Regional Cancer Centre
-
Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital
-
-
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 ovarian epithelial, primary peritoneal, or fallopian tube cancer
- Progressive, persistent, or recurrent disease
- Measurable disease outside prior radiotherapy field unless disease progression occurred after radiotherapy
Tumor lesions accessible for biopsy
- Patients with a medical contraindication to tumor biopsy may be allowed at the discretion of the principal investigator
No more than 2 prior chemotherapy regimens
- At least 1 regimen must have contained a platinum agent (i.e., carboplatin or cisplatin)
- No known brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2 OR
- Karnofsky 60-100%
Life expectancy
- More than 12 weeks
Hematopoietic
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than upper limit of normal (ULN)
- AST/ALT no greater than 2.5 times ULN
Renal
- Creatinine no greater than ULN OR
- Creatinine clearance at least 50 mL/min
Cardiovascular
- No history of coronary artery disease
- No symptomatic cardiac dysfunction
- No cardiac pathology by electrocardiogram* NOTE: *Patients with symptomatic coronary artery disease must undergo an electrocardiogram
Pulmonary
- No symptomatic pulmonary dysfunction
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 8 weeks after study participation
- No prior allergic reaction attributed to compounds of similar chemical or biological composition to UCN-01 or other study agents
No insulin-dependent diabetes mellitus
- Diabetes controlled by diet or oral hypoglycemic agents allowed at the discretion of the investigator
- No other concurrent uncontrolled illness
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 4 weeks since prior biologic therapy and recovered
Chemotherapy
- See Disease Characterisitcs
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- No prior topotecan
- No other prior topoisomerase I inhibitors
Endocrine therapy
- More than 4 weeks since prior hormonal therapy and recovered
Radiotherapy
- See Disease Characteristics
- More than 4 weeks since prior radiotherapy and recovered
- No prior radiotherapy to more than 40% of bone marrow
- No prior mediastinal irradiation
Surgery
- More than 4 weeks since prior surgery and recovered
Other
- No other concurrent anticancer therapy
- No other concurrent investigational agents
- No concurrent combination antiretroviral therapy for HIV-positive patients
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Masking: Ingen (Open Label)
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Hal W. Hirte, MD, FRCP(C), Margaret and Charles Juravinski Cancer Centre
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (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
- Neoplasmer etter histologisk type
- Neoplasmer
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Karsinom
- Neoplasmer, kjertel og epitel
- Genitale neoplasmer, kvinnelige
- Sykdommer i det endokrine systemet
- Sykdommer i eggstokkene
- Adnexal sykdommer
- Gonadal lidelser
- Neoplasmer i endokrine kjertel
- Eggledersykdommer
- Neoplasmer i eggstokkene
- Egglederneoplasmer
- Karsinom, ovarieepitel
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Antineoplastiske midler
- Topoisomerasehemmere
- Proteinkinasehemmere
- Topoisomerase I-hemmere
- Topotekan
- 7-hydroksystaurosporin
Andre studie-ID-numre
- PMH-PHL-019
- CDR0000339563 (Registeridentifikator: PDQ (Physician Data Query))
- NCI-6402
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