- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00897806
Identifying Genetic Markers That Predict Response to Paclitaxel in Patients With Newly Diagnosed Stage III or Stage IV Ovarian Epithelial Cancer or Primary Peritoneal Cancer
Feasibility of Measuring Gene Expression Patterns Using Tissue Acquisition of Primary Stage 3 & 4 Epithelial Ovarian Cx or Primary Peritoneal Cx & Gene Expression Array Technology for Predicting Paclitaxel Chemotherapy
RATIONALE: DNA analysis of tumor tissue from patients with cancer may help doctors predict how patients respond to treatment and plan the best treatment.
PURPOSE: This laboratory study is identifying genetic markers that predict response to paclitaxel in patients with newly diagnosed stage III or stage IV ovarian epithelial cancer or primary peritoneal cancer.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
OBJECTIVES:
Primary
- Identify genetic markers of paclitaxel chemosensitivity and/or chemoresistance, using gene expression arrays, in patients with newly diagnosed stage III or IV ovarian epithelial cancer or primary peritoneal cancer treated with single-agent weekly paclitaxel followed by paclitaxel in combination with carboplatin.
- Correlate RNA expression levels with clinical response in patients treated with this regimen.
Secondary
- Determine the response rate in patients treated with this regimen.
- Determine the progression-free survival and overall survival of patients treated with this regimen.
- Compare transcriptional profiles of primary tumors vs tissue obtained at second-look surgery in patients treated with this regimen.
- Identify differential expression between pre- and post-treatment tissue in patients treated with this regimen.
OUTLINE: This is a pilot study.
Pre- and post-chemotherapy tumor samples undergo transcriptional profiling using cDNA microarrays to identify gene overexpression. The gene expression profiles of paclitaxel-sensitive tumors are compared with those that are paclitaxel resistant to identify gene markers that are associated with response to paclitaxel.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
-
-
Texas
-
Houston, Texas, Vereinigte Staaten, 77030
- UT MD Anderson Cancer Center
-
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- Patients with newly diagnosed histologically confirmed advanced stage (III & IV) epithelial ovarian cancer, fallopian tube or peritoneal cancer. --OR-- Patients with a suspected malignancy who are unsuitable candidates for surgery (i.e., those with medical co-morbidities, massive effusions, or tumor burden such that an optimal resection is unlikely) who undergo a core biopsy that is positive for malignancy.
- Patients who have undergone tumor reduction must have either stage III suboptimal (> 2 cm residual) disease or stage IV disease.
- Patients may have had no prior chemotherapeutic regimen.
- Zubrod performance status of 0, 1, or 2.
- Patients must have recovered from effects of recent surgery. They should be free of significant infection.
- Patients must have adequate: Bone marrow function: WBC >/= than 3,000/microlitre, platelets > 100,000/microlitre, absolute neutrophil (ANC) count >/= than 1.5/microlitre. Renal function: Creatinine </= 1.5 mg%. Hepatic function: Bilirubin </= 1.5 mg/dl, SGOT and alkaline phosphatase </= 3 X institutional normal.
- Patients must have adequate: Neurologic function: Pre-existing peripheral neurologic toxicity is allowed but limited to parasthesia and decreased vibratory sense without motor weakness. Intermittent constipation managed with laxatives is allowed, without evidence of bowel obstruction. Psychiatric function: Functions independently without evidence of delirium, confusion, suicidal ideation, or untreated depression.
- Patients who have signed an approved informed consent.
Exclusion Criteria:
- Patients with borderline or grade 1 (low grade) tumors.
- Patients who have received any prior cytotoxic chemotherapy or radiotherapy.
- Patients with septicemia, severe infection, acute hepatitis, or gastrointestinal bleeding at the time of protocol entry.
- Patients with unstable angina or those who have had a myocardial infarction within the past six months. Patients with evidence of abnormal cardiac conduction (e.g., bundle branch block, heart block, etc.) are eligible if their disease has been stable for the past six months.
- Patients whose circumstances do not permit completion of the study or the required follow-up.
- Patients with a history of another malignancy within 5 years. Patients who have had a prior malignancy but remain continuously free of recurrent or persistent disease for more than 5 years may be entered in the study after consultation with the study chair.
- Patients with significant pre-existing cardiac disease (NYHA class III-IV) will be excluded.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: Nur Fall
- Zeitperspektiven: Interessent
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
---|---|
Genetic Markers
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Genetic markers of paclitaxel chemosensitivity and/or chemoresistance
Zeitfenster: 2 years
|
2 years
|
Correlation of RNA expression levels with clinical response
Zeitfenster: 2 years
|
2 years
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Response rate to weekly paclitaxel in chemotherapy naive patients
Zeitfenster: Every 3 months post treatment
|
Resonse measured by clinical assessments every 3 months post treatment.
|
Every 3 months post treatment
|
Progression-free survival
Zeitfenster: Every 3 months post treatment
|
Influence of weekly paclitaxel followed by paclitaxel in combination with carboplatin on progression-free survival by clinical assessments every 3 months post treatment
|
Every 3 months post treatment
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: David M. Gershenson, MD, M.D. Anderson Cancer Center
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
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
Schlüsselwörter
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
- Eierstocktumoren
- Karzinom, Eierstockepithel
Andere Studien-ID-Nummern
- ID00-408
- P30CA016672 (US NIH Stipendium/Vertrag)
- P50CA083639 (US NIH Stipendium/Vertrag)
- MDA-ID-00408 (Andere Kennung: UT MD Anderson Cancer Center)
- CDR0000355794 (Registrierungskennung: NCI PDQ)
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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