- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00003560
Docetaxel Plus Carboplatin in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
A Phase II Study of Docetaxel and Carboplatin for Suboptimally Debulked Stage III or Stage IV Ovarian and Fallopian Tube Carcinoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and carboplatin in treating patients who have stage III or stage IV ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES:
- Evaluate the response rate, duration of response, and progression-free and overall survival of previously untreated patients with suboptimally debulked stage III or stage IV ovarian carcinoma, fallopian tube carcinoma, papillary serous cancer of the uterus, or primary peritoneal carcinoma treated with docetaxel and carboplatin.
- Evaluate the feasibility and toxicity of this regimen in these patients.
- Evaluate the effect of this regimen on quality of life of these patients.
OUTLINE: This is an open-label study.
Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed prior to therapy and then after every 3 courses of chemotherapy.
PROJECTED ACCRUAL: Approximately 14-40 patients will be accrued for this study within 2.5 years.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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New York
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New York, New York, Forenede Stater, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
DISEASE CHARACTERISTICS:
Histologically confirmed previously untreated ovarian cancer, fallopian tube carcinoma, papillary serous cancer of the uterus, or primary peritoneal carcinoma
- Suboptimally debulked stage III or suboptimally or optimally debulked stage IV
Measurable or evaluable disease
- CNS lesions, lytic bone lesions, and radiated lesions (unless there is documented progression after radiotherapy) are not considered measurable
- CA 125 levels above 49 units/mL in the absence of cirrhosis or nonmalignant gross ascites are considered evaluable
- Ineligible for other high-priority national or institutional study
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- ECOG 0-1
Life expectancy:
- More than 2 months
Hematopoietic:
- WBC greater than 3,000/mm3
- Platelet count greater than 100,000/mm3
Hepatic:
- Bilirubin less than 1.5 times upper limit of normal (ULN)
- SGOT and/or SGPT less than 2.5 times ULN OR
- SGOT and/or SGPT no greater than 2.5 times ULN if alkaline phosphatase no greater than ULN OR
- Alkaline phosphatase no greater than 4 times ULN if SGOT and/or SGPT no greater than ULN
- No SGOT and/or SGPT greater than 1.5 times ULN with alkaline phosphatase greater than 2.5 times ULN
- Alkaline phosphatase less than 350 U/L
Renal:
- BUN less than 1.5 times normal
- Creatinine less than 1.5 times ULN
Other:
- No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or skin cancer
- No other serious medical or psychiatric illness
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
- No other concurrent chemotherapy
Endocrine therapy:
- No concurrent hormone therapy
Radiotherapy:
- See Disease Characteristics
- No prior radiotherapy
Surgery:
- See Disease Characteristics
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Maskning: Ingen (Åben etiket)
Samarbejdspartnere og efterforskere
Efterforskere
- Studiestol: Amy D. Tiersten, MD, Herbert Irving Comprehensive Cancer Center
Datoer for undersøgelser
Studer store datoer
Studiestart
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
- Neoplasmer
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Uterine neoplasmer
- Genitale neoplasmer, kvindelige
- Livmodersygdomme
- Adnexale sygdomme
- Æggeledersygdomme
- Æggelederneoplasmer
- Endometriale neoplasmer
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Docetaxel
- Carboplatin
Andre undersøgelses-id-numre
- CDR0000066624
- CPMC-IRB-8437
- NCI-V98-1467
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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