- ICH GCP
- Registr klinických studií v USA
- Klinická 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
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 2
Kontakty a umístění
Studijní místa
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Minnesota
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Rochester, Minnesota, Spojené státy, 55905
- Mayo Clinic
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: 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.
|
Vzhledem k tomu, IV
Ostatní jména:
Vzhledem k tomu, IV
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Proportion of Patients Who Experience a Confirmed Response According to Modified RECIST Criteria.
Časové okno: 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).
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Times to Progression
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Paul Haluska, Mayo Clinic
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Nemoci trávicího systému
- Novotvary podle histologického typu
- Novotvary
- Urogenitální novotvary
- Novotvary podle místa
- Karcinom
- Novotvary, žlázové a epiteliální
- Peritoneální onemocnění
- Genitální novotvary, ženy
- Onemocnění endokrinního systému
- Onemocnění vaječníků
- Adnexální onemocnění
- Gonadální poruchy
- Novotvary trávicího systému
- Novotvary endokrinních žláz
- Novotvary břicha
- Novotvary vaječníků
- Peritoneální novotvary
- Karcinom, ovariální epiteliální
- Fyziologické účinky léků
- Molekulární mechanismy farmakologického působení
- Antiinfekční látky
- Antivirová činidla
- Inhibitory enzymů
- Antimetabolity, Antineoplastika
- Antimetabolity
- Antineoplastická činidla
- Imunosupresivní látky
- Imunologické faktory
- Gemcitabin
Další identifikační čísla studie
- NCI-2009-00052 (Identifikátor registru: CTRP (Clinical Trial Reporting Program))
- P30CA015083 (Grant/smlouva NIH USA)
- N01CM62205 (Grant/smlouva NIH USA)
- 6307 (Jiný identifikátor: CTEP)
- CDR0000388036
- NCI-6307
- MAYO-MC0362
- MC0362 (Jiný identifikátor: Mayo Clinic)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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