- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00407407
ABI-007 With Carboplatin as First-Line Therapy in Patients With Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Carcinoma
16 oktober 2019 uppdaterad 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.
Studieöversikt
Status
Avslutad
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
6
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Texas
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Houston, Texas, Förenta staterna, 77230-1439
- University of Texas, MD Anderson Cancer Center
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Primary: Safety/tolerability endpoints are the maximum tolerated dose and dose-limiting toxicities
Tidsram: 18 months
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18 months
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Sekundära resultatmått
Resultatmått |
Tidsram |
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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
Tidsram: Patient progression or until discontinuation
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Patient progression or until discontinuation
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Robert Coleman, MD, Univeristy of Texas, MD Anderson Cancer Center
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 november 2006
Primärt slutförande (Faktisk)
1 februari 2008
Avslutad studie (Faktisk)
1 februari 2008
Studieregistreringsdatum
Först inskickad
1 december 2006
Först inskickad som uppfyllde QC-kriterierna
1 december 2006
Första postat (Uppskatta)
5 december 2006
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
18 oktober 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 oktober 2019
Senast verifierad
1 oktober 2019
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Neoplasmer efter histologisk typ
- Urogenitala neoplasmer
- Neoplasmer efter plats
- Neoplasmer, körtel och epitel
- Peritoneala sjukdomar
- Genitala neoplasmer, hona
- Sjukdomar i det endokrina systemet
- Ovariella sjukdomar
- Adnexala sjukdomar
- Gonadal sjukdomar
- Neoplasmer i matsmältningssystemet
- Neoplasmer i endokrina körtel
- Äggledarsjukdomar
- Neoplasmer i buken
- Neoplasmer
- Carcinom
- Ovariella neoplasmer
- Äggledarneoplasmer
- Peritoneala neoplasmer
- Antineoplastiska medel
- Karboplatin
- Albuminbundet paklitaxel
Andra studie-ID-nummer
- CA034
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Ovariella neoplasmer
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Ann & Robert H Lurie Children's Hospital of ChicagoOkändCystektomi | Godartade cystor Ovarian | Torsion | Maligna cystor OvarianFörenta staterna
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Universitair Ziekenhuis BrusselRekrytering
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Royal Surrey County Hospital NHS Foundation TrustOkändÄggstockscancer | Äggledarcancer | Peritoneal cancer | Ovarial neoplasm | Ovarian Neoplasm EpitelialStorbritannien
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Assistance Publique - Hôpitaux de ParisAktiv, inte rekryterandeOkomplicerad Tubo Ovarian AbscessFrankrike
-
Universitair Ziekenhuis BrusselRekrytering
-
Royal Surrey County Hospital NHS Foundation TrustRekryteringÄggledarneoplasmer | Äggstockscancer | Äggledarcancer | Peritoneal cancer | Ovarial neoplasm | Ovarian Neoplasm EpitelialStorbritannien
-
Leiden University Medical CenterUniversity Medical Center Groningen; Erasmus Medical CenterRekryteringBRCA1-mutation | BRCA2-mutation | Homolog rekombinationsbrist | Ovarian Neoplasm EpitelialNederländerna
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Wake Forest University Health SciencesNational Cancer Institute (NCI)AvslutadMetastatisk malign neoplasm | Ooperbar malign neoplasm | Avancerad malign neoplasmFörenta staterna
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Massachusetts General HospitalRekryteringMalign neoplasm | Benign neoplasmFörenta staterna
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Zhejiang Cancer HospitalAvslutadOvarian Neoplasm Epitelial
Kliniska prövningar på ABI-007
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CelgeneIndragenFast tumörFörenta staterna
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National Research Council, SpainHospital Universitario 12 de OctubreAvslutad
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CelgeneAvslutadBukspottskörtelcancerFörenta staterna, Kanada, Spanien, Australien, Frankrike, Tyskland, Österrike, Italien, Ukraina
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CelgeneAvslutadMelanom | MetastaserFörenta staterna
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Celgene CorporationAvslutadBröstneoplasmer | Metastaser, NeoplasmFörenta staterna
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Celgene CorporationAvslutadNeoplasmer | Metastaser, NeoplasmFörenta staterna
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Celgene CorporationAvslutadBröstneoplasmer | Metastaser, NeoplasmFörenta staterna
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University Health Network, TorontoCelgene CorporationAvslutad
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Gynecologic Oncology GroupNational Cancer Institute (NCI)AvslutadÅterkommande äggstockscancer | Fallopian Tube Carcinom | Primärt peritonealt karcinomFörenta staterna