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Gemcitabine Hydrochloride and Tanespimycin in Treating Patients With Recurrent Advanced Ovarian Epithelial or Peritoneal Cavity Cancer

2 maggio 2014 aggiornato da: National Cancer Institute (NCI)

A Phase II Trial Of Gemcitabine in Combination With 17-Allylaminogeldamycin (17-AAG) In Advanced Epithelial Ovarian And Primary Peritoneal Carcinoma

Phase II trial to study the effectiveness of gemcitabine hydrochloride and tanespimycin in treating patients who have recurrent advanced ovarian epithelial or primary peritoneal cavity cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride and tanespimycin, work in different ways to stop tumor cells from dividing so they stop growing or die.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

29

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Minnesota
      • Rochester, Minnesota, Stati Uniti, 55905
        • Mayo Clinic

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Dato IV
Altri nomi:
  • Gemzar
  • gemcitabina
  • dFdC
  • difluorodeossicitidina cloridrato
Dato IV
Altri nomi:
  • 17-AA

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of Patients Who Experience a Confirmed Response According to Modified RECIST Criteria.
Lasso di tempo: Participants were evaluated every 6 weeks on treatment, with median treatment length of 12 weeks (3 week minimum and 42 week maximum).

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).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Times to Progression
Lasso di tempo: Participants were evaluated every 6 weeks on treatment (maximum 42 weeks), and followed up to 5 years from registration.
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
Participants were evaluated every 6 weeks on treatment (maximum 42 weeks), and followed up to 5 years from registration.
Overall Survival
Lasso di tempo: Every 3 months until disease progression and then every 6 months for up to 5 years.
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.
Every 3 months until disease progression and then every 6 months for up to 5 years.
Toxicity
Lasso di tempo: Participants were evaluated every 6 weeks on treatment (maximum 42 weeks)
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.
Participants were evaluated every 6 weeks on treatment (maximum 42 weeks)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Paul Haluska, Mayo Clinic

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 ottobre 2007

Completamento primario (Effettivo)

1 aprile 2010

Completamento dello studio (Effettivo)

1 marzo 2012

Date di iscrizione allo studio

Primo inviato

6 ottobre 2004

Primo inviato che soddisfa i criteri di controllo qualità

7 ottobre 2004

Primo Inserito (Stima)

8 ottobre 2004

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

20 maggio 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 maggio 2014

Ultimo verificato

1 ottobre 2011

Maggiori informazioni

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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