- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00028912
Bortezomib and Carboplatin in Treating Patients With Recurrent or Progressive Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
Phase I Trial of Bortezomib (NSC 681239, IND#58443) and Carboplatin in Recurrent or Progressive Epithelial Ovarian Cancer or Primary Peritoneal Cancer
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy such as carboplatin use different ways to stop tumor cells from dividing so they stop growing or die. Bortezomib may help carboplatin kill more tumor cells by making tumor cells more sensitive to the drug.
PURPOSE: Phase I trial to study the effectiveness of combining bortezomib with carboplatin in treating patients who have recurrent or progressive ovarian epithelial, primary peritoneal, or fallopian tube cancer.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
OBJECTIVES:
- Determine the maximum tolerated dose of bortezomib in combination with carboplatin in patients with recurrent or progressive ovarian epithelial, primary peritoneal, or fallopian tube cancer.
- Determine the toxicity of this regimen in these patients.
- Determine the pharmacodynamics of this regimen in these patients by measurement of 20S proteasome inhibition in whole blood.
- Correlate toxicity with 20S proteasome inhibition in a whole blood assay in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of bortezomib.
Patients receive carboplatin IV over 30 minutes on days 1 and 8 followed by 1 week of rest during the first course of treatment. Beginning with the second course, patients receive bortezomib IV on days 1, 4, 8, and 11 and carboplatin IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 8 additional patients are accrued and treated at that dose.
PROJECTED ACCRUAL: A total of 3-32 patients will be accrued for this study.
Studientyp
Phase
- Phase 1
Kontakte und Standorte
Studienorte
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New York
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New York, New York, Vereinigte Staaten, 10021
- Memorial Sloan-Kettering Cancer Center
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer
- Recurrent or progressive disease
Received at least 1 prior platinum-based chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound for primary disease
- May include high-dose therapy, consolidation, or extended therapy after surgical or non-surgical assessment
- No brain metastases or leptomeningeal involvement
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- Karnofsky 70-100%
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,000/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 8.0 g/dL
Hepatic:
- AST and ALT no greater than 2.5 times upper limit of normal
- Bilirubin no greater than 1.8 mg/dL
Renal:
- Creatinine no greater than 1.5 mg/dL
Cardiovascular:
- LVEF greater than 50% by radionuclide ventriculogram or two-dimensional echocardiogram
- No peripheral vascular disease requiring surgical management
- No prior myocardial infarction
- No congestive heart failure
- No orthostatic hypotension
- No acute ischemia or significant conduction abnormality (bifascicular block, defined as left anterior hemiblock with right bundle branch block, second or third degree AV blocks) as evidenced by electrocardiogram
- No prior cerebrovascular event
Other:
- No peripheral neuropathy grade 2 or greater
- No other serious medical or psychiatric illness
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- No more than 2 prior regimens for recurrent disease, including 1 non-platinum containing regimen
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered
Endocrine therapy:
- At least 1 week since prior hormonal therapy directed at primary tumor
- Concurrent hormone replacement therapy allowed
Radiotherapy:
- Not specified
Surgery:
- See Disease Characteristics
- At least 2 weeks since prior major surgery
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Studienstuhl: Carol Aghajanian, MD, Memorial Sloan Kettering Cancer Center
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Aghajanian C, Dizon DS, Sabbatini P, Raizer JJ, Dupont J, Spriggs DR. Phase I trial of bortezomib and carboplatin in recurrent ovarian or primary peritoneal cancer. J Clin Oncol. 2005 Sep 1;23(25):5943-9. doi: 10.1200/JCO.2005.16.006.
- Aghajanian C, Dizon D, Yan XJ, et al.: Phase I trial of PS-341 and carboplatin in recurrent ovarian cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1815, 2003.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Neubildungen nach histologischem Typ
- Neubildungen
- Urogenitale Neoplasmen
- Neubildungen nach Standort
- Karzinom
- Neubildungen, Drüsen und Epithelien
- Genitale Neubildungen, weiblich
- Erkrankungen des endokrinen Systems
- Eierstockerkrankungen
- Adnexerkrankungen
- Gonadenstörungen
- Neoplasmen der endokrinen Drüse
- Eileitererkrankungen
- Eierstocktumoren
- Eileiterneoplasmen
- Karzinom, Eierstockepithel
- Antineoplastische Mittel
- Carboplatin
- Bortezomib
Andere Studien-ID-Nummern
- CDR0000069146
- MSKCC-01097
- NCI-5326
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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