- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00407407
ABI-007 With Carboplatin as First-Line Therapy in Patients With Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Carcinoma
16. oktober 2019 oppdatert av: Celgene
A Phase I Dose Escalation Study of ABI-007 With Carboplatin TM as First-Line Therapy in Patients With Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Carcinoma
The primary purpose of this study is to determine the maximum tolerated dose and dose-limiting toxicities (DLTs) of weekly and every 3-weeks ABI-007 in combination with carboplatin (area under the curve [AUC]=6) in patients with ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
Studieoversikt
Status
Avsluttet
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
6
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Texas
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Houston, Texas, Forente stater, 77230-1439
- University of Texas, MD Anderson Cancer Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
Inclusion Criteria:
- Patients with a histological diagnosis of primary peritoneal carcinoma, fallopian tube or epithelial ovarian carcinoma (Stage III or IV) with either (optimal less than or equal to 1 cm) residual disease or suboptimal residual disease following initial appropriate surgery.
- Patients with the following histologically confirmed types of ovarian cancer are eligible: serous cystadenocarcinoma, mucinous cystadenocarcinoma, clear cell adenocarcinoma, adenocarcinoma (unspecified), malignant Brenner's tumor, endometrioid adenocarcinoma, undifferentiated carcinoma, mixed epithelial carcinoma and transitional cell carcinoma. Patients with extraovarian papillary serous cystadenocarcinoma are eligible.
- Patients who do not have measurable disease may be included and will be assessed for toxicity and progression-free survival only. Measurable disease is NOT required but when present will be followed to assess response. For patients to be evaluated for response of measurable disease, tumor must be greater than or equal to 2.0 cm with conventional computed tomography (CT) imaging or greater than or equal to 1.0 cm with spiral CT imaging.
- No prior chemotherapy for ovarian cancer is permitted.
- Patients must be entered no more than 12 weeks postoperatively.
- ECOG performance status 0-2.
- Age greater than or equal to 18 years.
Patient has the following blood counts at Baseline:
- ANC greater than or equal to 1.5 x 10^9 cells/L;
- Platelets greater than or equal to 100 x 10^9 cells/L;
- Hemoglobin (Hgb) greater than or equal to 9 g/dL.
Patient has the following blood chemistry levels at Baseline:
- AST (SGOT), ALT (SGPT) less than or equal to 2.5x upper limit of normal range (ULN);
- Total bilirubin less than or equal to ULN;
- Creatinine less than or equal to 1.5 mg/dL.
- Peripheral neuropathy Grade 0 or 1 by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).
- It is assumed that almost all patients already had bilateral oophorectomy. However, if a female of childbearing potential, has a negative pregnancy test (within 72 hours of the first dose of study drug), the patient must agree to use an effective method to avoid pregnancy for the duration of the study.
- Patients must have signed an approved informed consent and authorization permitting the release of personal health information.
Exclusion Criteria:
- Patients who have received any prior treatment, other than initial debulking surgery, for the cancer being treated in this study. Patients may have received adjuvant chemotherapy for localized breast cancer, if the therapy was completed greater than or equal to 3 years before registration in this study and if the patient remains free of recurrent or metastatic disease.
- Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis. Prior radiation for localized cancer of the breast, head and neck or skin is permitted if it was completed greater than or equal to 3 years before registration in this study and if the patient remains free of recurrent metastatic disease.
- Concurrent immunotherapy or hormonal therapy for ovarian cancer.
- Parenchymal brain metastases, unless documented to be clinically and radiographically stable for at least 6 months after treatment for the disease.
- Serious intercurrent medical or psychiatric illness, including serious active infection (i.e. requiring antibiotics).
- Patients with borderline or low malignant potential tumors.
- History of other malignancy within the last 5 years, which could affect the diagnosis or assessment of ovarian cancer.
- Patients who have received an investigational drug within the previous 3 weeks.
- Patient is currently enrolled in a different clinical study in which investigational procedures are performed or investigational therapies are administered. Also, a patient may not enroll in such clinical trials while participating in this study.
- Pregnant or nursing women.
- Patients with unstable angina or those who have had myocardial infarction within the past 6 months. Patients with evidence of cardiac conduction abnormalities (e.g., bundle branch block, heart block) are eligible if their cardiac status has been stable for the 6 months prior to study entry.
- Patients with prior hypersensitivity to both Taxol and Taxotere.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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Primary: Safety/tolerability endpoints are the maximum tolerated dose and dose-limiting toxicities
Tidsramme: 18 months
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18 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Safety-AEs, SAEs, Lab abnormalities, incidence of patients experiencing dose modification of those interruptions &/or premature of d/c pf study drug
Tidsramme: Patient progression or until discontinuation
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Patient progression or until discontinuation
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Robert Coleman, MD, Univeristy of Texas, MD Anderson Cancer Center
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. november 2006
Primær fullføring (Faktiske)
1. februar 2008
Studiet fullført (Faktiske)
1. februar 2008
Datoer for studieregistrering
Først innsendt
1. desember 2006
Først innsendt som oppfylte QC-kriteriene
1. desember 2006
Først lagt ut (Anslag)
5. desember 2006
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
18. oktober 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. oktober 2019
Sist bekreftet
1. oktober 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Neoplasmer etter histologisk type
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- 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
- Eggledersykdommer
- Abdominale neoplasmer
- Neoplasmer
- Karsinom
- Neoplasmer i eggstokkene
- Egglederneoplasmer
- Peritoneale neoplasmer
- Antineoplastiske midler
- Karboplatin
- Albuminbundet paklitaksel
Andre studie-ID-numre
- CA034
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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