- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00217568
Docetaxel and Carboplatin in Treating Patients With Relapsed Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cavity Cancer
A Phase II Trial of Docetaxel and Carboplatin for First Relapsed Platinum-Sensitive Stage III and IV Advanced Ovarian Cancer or Peritoneal Carcinoma
RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, 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 how well giving docetaxel together with carboplatin works in treating patients with relapsed stage III or stage IV ovarian epithelial or primary peritoneal cavity cancer.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
OBJECTIVES:
- Determine the toxicity of docetaxel and carboplatin in patients with platinum-sensitive stage III or IV ovarian epithelial or primary peritoneal cavity cancer in first relapse.
- Determine the response rates (complete and partial response) in patients treated with this regimen.
- Determine relapse rates and event-free survival and overall survival rates in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Patients also receive pegfilgrastim subcutaneously on day 2 . Treatment repeats every 21 days for up to 6 courses.
After completion of study treatment, patients are followed at 3 weeks, every 3 months for 2 years, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4-5 years.
Studietype
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
Washington
-
Seattle, Washington, Forente stater, 98195
- University of Washington School of Medicine
-
Seattle, Washington, Forente stater, 98104
- Pacific Gynecology Specialists
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Seattle, Washington, Forente stater, 98109-1024
- Fred Hutchinson Cancer Research Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial or primary peritoneal cavity cancer
- Stage III or IV disease
- No borderline tumors
Measurable or evaluable disease
- Measurable disease, defined as evidence of disease by physical examination or radiographic evaluation
- Evaluable disease, defined as CA 125 ≥ 100 U/mL (confirmed by 2 blood tests performed ≥ 1 week apart)
In first relapse
- Platinum-sensitive disease, defined as initial relapse > 6 months after completion of a platinum-based regimen
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 60-100%
Life expectancy
- Not specified
Hematopoietic
- Platelet count ≥ 100,000/mm^3
- Absolute neutrophil count ≥ 1,500/mm^3
Hepatic
- Bilirubin normal
Meets 1 of the following criteria:
- SGOT and/or SGPT ≤ 1.5 times upper limit of normal (ULN) AND alkaline phosphatase (AP) ≤ 2.5 times ULN
- SGOT and/or SGPT ≤ 5.0 times ULN AND AP normal
Renal
- Creatinine ≤ 2.0 mg/dL
- Creatinine clearance > 50 mL/min
Cardiovascular
- LVEF ≥ 50%
- No poorly controlled arrhythmia
- No unstable coronary artery disease or myocardial infarction within the past year
Other
- HIV negative
- No pre-existing peripheral neuropathy > grade 2
- No history of allergy to study drugs
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
- At least 3 weeks since prior chemotherapy and recovered
Endocrine therapy
- Not specified
Radiotherapy
- At least 3 weeks since prior radiotherapy and recovered
Surgery
- Recovered from recent prior surgery
Other
- No concurrent myelosuppressive therapy
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Masking: Ingen (Open Label)
Hva måler studien?
Primære resultatmål
Resultatmål |
|---|
|
Giftighet
|
|
Total overlevelse
|
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Begivenhetsfri overlevelse
|
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Tilbakefallsrater
|
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Response rates (complete and partial response)
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Leona A. Holmberg, MD, PhD, Fred Hutchinson Cancer Center
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
- Sykdommer i fordøyelsessystemet
- Neoplasmer etter histologisk type
- Neoplasmer
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Karsinom
- Neoplasmer, kjertel og epitel
- Peritoneale sykdommer
- Genitale neoplasmer, kvinnelige
- Sykdommer i det endokrine systemet
- Sykdommer i eggstokkene
- Adnexal sykdommer
- Gonadal lidelser
- Neoplasmer i fordøyelsessystemet
- Neoplasmer i endokrine kjertel
- Abdominale neoplasmer
- Neoplasmer i eggstokkene
- Peritoneale neoplasmer
- Karsinom, ovarieepitel
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitosemodulatorer
- Docetaxel
- Karboplatin
Andre studie-ID-numre
- PSOC 1702
- PSOC-1702
- AVENTIS-PSOC-1702
- PSOC-IRB-4861
- CDR0000441307 (Registeridentifikator: PDQ)
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