- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00093496
Gemcitabine Hydrochloride and Tanespimycin in Treating Patients With Recurrent Advanced Ovarian Epithelial or Peritoneal Cavity Cancer
A Phase II Trial Of Gemcitabine in Combination With 17-Allylaminogeldamycin (17-AAG) In Advanced Epithelial Ovarian And Primary Peritoneal Carcinoma
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
OBJECTIVES:
I. Determine the response rate, time to progression, and survival of patients with recurrent advanced ovarian epithelial or primary peritoneal cavity cancer treated with gemcitabine hydrochloride and 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) (tanespimycin).
II. Determine the toxicity of this regimen in these patients. III. Correlate the effect of 17-AAG alone on chaperone and client proteins in tumor samples and peripheral blood mononuclear cells with response, time to progression, and survival of these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to gemcitabine hydrochloride therapy (gemcitabine hydrochloride-naive/no prior exposure to gemcitabine hydrochloride vs gemcitabine hydrochloride-resistant/prior exposure to gemcitabine hydrochloride as a single agent with disease progression while on treatment). Patients receive tanespimycin intravenously (IV) over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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Minnesota
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Rochester, Minnesota, Vereinigte Staaten, 55905
- Mayo Clinic
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
Diagnosis of ovarian epithelial or primary peritoneal cavity cancer
- Relapsed disease
- Persistent disease
Platinum-resistant disease, defined as having evidence of disease that would be expected to be non-responsive to additional platinum-containing regimens or contraindication to platinum-based chemotherapy and 1 of the following:
- Failure to obtain a complete response to initial platinum therapy
- Recurrence < 6 months after completing a platinum-containing regimen for initial or recurrent disease
- Any of the above situations and following treatment with additional chemotherapy regimens (e.g., non-platinum containing regimens)
- Relative or absolute contraindication to platinum-based chemotherapy regimens (e.g., platinum allergy) as determine by the investigator
Measurable or evaluable disease
- Patients with a rising CA 125 level, even in the absence of other indicators of disease, allowed provided CA 125 is ≥ 2 times upper limit of normal (ULN)
- Patients with accessible disease must be willing to undergo tumor biopsies
- No CNS metastases
- Performance status - ECOG 0-2
- WBC ≥ 3,000/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9.0 g/dL
- Bilirubin normal
- Alkaline phosphatase ≤ 2.5 times ULN
- AST ≤ 2.5 times ULN
- Creatinine ≤ 1.5 times ULN
- Ejection fraction > 40% by ECHO for patients with prior anthracycline therapy
No significant cardiac disease including any of the following:
- New York Heart Association class III or IV heart disease
- History of myocardial infraction within the past year
- Uncontrolled dysrhythmias or requirement for antiarrhythmic drugs
- Poorly controlled angina
- No history of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
- No history of QTc ≥ 500 msec
- No active ischemic heart disease within the past 12 months
- No congenital long QT syndrome
- No left bundle branch block
- No cardiac symptoms ≥ grade 2
- No history of cardiac toxicity after receiving anthracyclines (e.g., doxorubicin hydrochloride, daunorubicin hydrochloride, mitoxantrone, bleomycin, or carmustine)
- Does not meet the medicare criteria for home oxygen
- No pulse oximetry at rest and exercise < 88%
No symptomatic pulmonary disease requiring medication including any of the following:
- Dyspnea on or off exertion
- Paroxysmal nocturnal dyspnea
- Oxygen requirement
- Significant pulmonary disease (e.g., chronic obstructive/restrictive pulmonary disease)
- No pulmonary symptoms ≥ grade 2
- No history of pulmonary toxicity after receiving anthracyclines (e.g., doxorubicin hydrochloride, daunorubicin hydrochloride, mitoxantrone, bleomycin, or carmustine)
- K+, Mg ++, and Ca ++ normal
- No seizure disorder
- No uncontrolled infection
- No history of serious allergic reaction to eggs
- More than 4 weeks since prior immunotherapy
- More than 4 weeks since prior biologic therapy
- No concurrent immunotherapy
- No concurrent routine or prophylactic colony-stimulating factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF])
- See Disease Characteristics
- More than 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered
Prior gemcitabine hydrochloride allowed provided 1 of the following criteria is met:
- Patients have no prior exposure to gemcitabine hydrochloride
- Patients who have prior exposure to gemcitabine hydrochloride as a single agent have experienced progressive disease while on treatment
- No other concurrent chemotherapy
- No prior radiotherapy to > 25% of bone marrow
No history of radiotherapy that potentially included the heart in the field (e.g., mantle)
- Chest wall irradiation or other radiotherapy techniques that do not include the heart in the radiation field area allowed
- More than 4 weeks since prior radiotherapy
- More than 4 weeks since prior radiopharmaceuticals
- No concurrent radiotherapy
- No other concurrent investigational therapy
- No concurrent medications that may prolong QTc
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Treatment (chemotherapy)
Patients are stratified according to gemcitabine hydrochloride therapy (gemcitabine hydrochloride-naive/no prior exposure to gemcitabine hydrochloride vs gemcitabine hydrochloride-resistant/prior exposure to gemcitabine hydrochloride as a single agent with disease progression while on treatment).
Patients receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
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Gegeben IV
Andere Namen:
Gegeben IV
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Proportion of Patients Who Experience a Confirmed Response According to Modified RECIST Criteria.
Zeitfenster: Participants were evaluated every 6 weeks on treatment, with median treatment length of 12 weeks (3 week minimum and 42 week maximum).
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Objective response will be measured using the modified RECIST criteria. A confirmed response requires an objective status of complete or partial response on 2 consecutive evaluations occurring 4 or more weeks apart. Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers. Partial Response (PR): At least a 30% decrease in the sum of the target lesions from the baseline. |
Participants were evaluated every 6 weeks on treatment, with median treatment length of 12 weeks (3 week minimum and 42 week maximum).
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Times to Progression
Zeitfenster: Participants were evaluated every 6 weeks on treatment (maximum 42 weeks), and followed up to 5 years from registration.
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Defined as the time from registration to the date of progression or last follow-up, whichever comes first.
Estimated using the method of Kaplan-Meier
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Participants were evaluated every 6 weeks on treatment (maximum 42 weeks), and followed up to 5 years from registration.
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Overall Survival
Zeitfenster: Every 3 months until disease progression and then every 6 months for up to 5 years.
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Defined as the time from registration to date of last follow-up or death due to any cause.
Estimated using the method of Kaplan-Meier.
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Every 3 months until disease progression and then every 6 months for up to 5 years.
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Toxicity
Zeitfenster: Participants were evaluated every 6 weeks on treatment (maximum 42 weeks)
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Defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 as an adverse event classified as either possibly, probably, or definitely related to study treatment.
The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.
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Participants were evaluated every 6 weeks on treatment (maximum 42 weeks)
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Paul Haluska, Mayo Clinic
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
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Verdauungssystems
- Neubildungen nach histologischem Typ
- Neubildungen
- Urogenitale Neoplasmen
- Neubildungen nach Standort
- Karzinom
- Neubildungen, Drüsen und Epithelien
- Peritonealerkrankungen
- Genitale Neubildungen, weiblich
- Erkrankungen des endokrinen Systems
- Eierstockerkrankungen
- Adnexerkrankungen
- Gonadenstörungen
- Neoplasmen des Verdauungssystems
- Neoplasmen der endokrinen Drüse
- Abdominelle Neubildungen
- Eierstocktumoren
- Peritoneale Neubildungen
- Karzinom, Eierstockepithel
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Antiinfektiva
- Antivirale Mittel
- Enzym-Inhibitoren
- Antimetaboliten, antineoplastisch
- Antimetaboliten
- Antineoplastische Mittel
- Immunsuppressive Mittel
- Immunologische Faktoren
- Gemcitabin
Andere Studien-ID-Nummern
- NCI-2009-00052 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))
- P30CA015083 (US NIH Stipendium/Vertrag)
- N01CM62205 (US NIH Stipendium/Vertrag)
- 6307 (Andere Kennung: CTEP)
- CDR0000388036
- NCI-6307
- MAYO-MC0362
- MC0362 (Andere Kennung: Mayo Clinic)
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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