- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00782275
Avastin and Temsirolimus Following Tyrosine Kinase Inhibitor Failure in Patients With Advanced Renal Cell Carcinoma
A Phase II Trial of Avastin and Temsirolimus Following Tyrosine Kinase Inhibitor Failure in Patients With Advanced Renal Cell Carcinoma
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Avastin, a humanized IgG1 monoclonal antibody (MAb), inhibits vascular endothelial growth factor (VEGF). VEGF is one of the most potent and specific proangiogenic factors and has been identified as a crucial regulator of both normal and pathological angiogenesis. Temsirolimus specifically inhibits the mammalian target of rapamycin (mTOR), a highly conserved serine/threonine kinase which regulates cell growth and metabolism in response to environmental factors. The combination avastin and temsirolimus has already demonstrated efficacy in the phase I setting
STATISTICAL CONSIDERATIONS:
The primary endpoint is 4-month PFS. The null and alternative hypotheses are 50% vs. 70%. Assuming 2 ineligible patients, the target sample size is 41 patients (39 eligible patients). The probability of concluding that the treatment is effective was >0.90 if the true rate is at least 70%. The probability of concluding that the treatment is effective was ≤ 0.10 if the true rate was 50% or less. If 24 or more patients are alive and progression-free at 4 months, then this regimen would be considered for further study.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02115
- Dana-Farber Cancer Institute
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Boston, Massachusetts, Stati Uniti, 02115
- Beth Israel Deaconess Medical Center
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Tennessee
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Nashville, Tennessee, Stati Uniti, 37232
- Vanderbilt Univeristy Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Histologically confirmed renal cell carcinoma in either primary or metastatic lesions. Non-clear histology will be allowed.
- Disease progression on a VEGF-targeted tyrosine kinase inhibitor as the most recent therapy or have experienced intolerable toxicity so as require discontinuation. Only one prior VEGF-targeted tyrosine kinase inhibitor.
- Must be off of VEGF-targeted tyrosine kinase inhibitor for 2 weeks or greater.
- One measurable lesion which is not curable by standard radiation therapy or surgery.
- The enrolling site must agree to obtain paraffin-embedded tumor blocks or at least 10 unstained, paraffin-embedded slides for submission for correlative studies.
- 18 years of age or older
- ECOG Performance Status of 0 or 1
- Baseline laboratory values as outlined in the protocol
- Life expectancy of greater than 3 months
- No prior malignancy diagnosed within the past three years, other than superficial basal cell and superficial squamous cell, or carcinoma in situ of the cervix.
Exclusion Criteria:
- Known CNS disease, except for treated brain metastases
- Previously treated with avastin or mTOR inhibitors
- Other then VEFG-targeted TKI, patients may only have had prior immunotherapy or chemotherapy for stage IV disease
- History of allergic reaction to Chinese hamster ovary cell products, other recombinant antibodies, or compounds of similar chemical or biologic composition to avastin or temsirolimus
- History of bleeding diathesis or coagulopathy. Therapeutic anticoagulants are allowed
- Patients with clinically significant cardiovascular disease
- Patients receiving enzyme-inducing antiepileptic drugs or any other CYP3A4 inducer such as rifampin or St. John's wort
- No serious non-healing wound, ulcer or bone fracture
- No uncontrolled intercurrent illness including , but not limited to, ongoing active infection requiring parental antibiotics or psychiatric illness/social situations that would limit compliance with study requirements
- HIV-positive receiving combination anti-retroviral therapy
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study
- Core biopsy or other minor surgical procedure, excluding placement of vascular access device, within 7 days prior to enrollment on study
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
- Known hypersensitivity to any component of avastin or temsirolimus
- Life expectancy of less than 12 weeks
- History of hemoptysis within 1 month prior to day 1
Piano di studio
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: bevacizumab and temsirolimus
bevacizumab: given intravenously at a dose of 10mg/kg every 2 weeks (days 1 and 15) temsirolimus: given intravenously at a dose of 25mg weekly on days 1, 8, 15, and 22 1 cycle=28-days There were no dose reductions for bevacizumab allowed. If bevacizumab was held, the same dose would be used if treatment were resumed. If temsirolimus was held, the same or a reduced dose (15mg IV weekly) could be used upon resumption of therapy. Treatment was continued until the development of unacceptable toxicity or progression. |
Altri nomi:
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
4-month Progression-Free Survival Rate
Lasso di tempo: Disease evaluations occurred every 8 weeks (+/- 1 wk) on treatment. Relevant for this endpoint was disease status at 4 months.
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4-month progression-free survival rate was defined as the percentage of participants absent death or progression based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST) before 4 months.
Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.
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Disease evaluations occurred every 8 weeks (+/- 1 wk) on treatment. Relevant for this endpoint was disease status at 4 months.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Objective Response Rate
Lasso di tempo: Disease evaluations occurred every 8 weeks (+/- 1 wk) on treatment; Treatment continued until disease progression or unacceptable toxicity. Median (range) of treatment duration for this study cohort was 5 cycles (1-39) [1 cycle=28days].
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Objective response (OR) rate is the percentage of participants achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment.
Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD.
To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met.
PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
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Disease evaluations occurred every 8 weeks (+/- 1 wk) on treatment; Treatment continued until disease progression or unacceptable toxicity. Median (range) of treatment duration for this study cohort was 5 cycles (1-39) [1 cycle=28days].
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Overall Survival
Lasso di tempo: Median follow-up for survival in this study cohort is 56 months.
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Overall survival (OS) is defined from the date of registration to date of death, or censored at the date the participant was last known alive.
OS is estimated based on the Kaplan-Meier method.
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Median follow-up for survival in this study cohort is 56 months.
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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: David McDermott, MD, Beth Israel Deaconess Medical Center
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Neoplasie per tipo istologico
- Neoplasie
- Neoplasie urologiche
- Neoplasie urogenitali
- Neoplasie per sede
- Malattie renali
- Malattie urologiche
- Adenocarcinoma
- Neoplasie, ghiandolari ed epiteliali
- Neoplasie renali
- Carcinoma, cellule renali
- Carcinoma
- Effetti fisiologici delle droghe
- Agenti antinfettivi
- Agenti antineoplastici
- Agenti immunosoppressivi
- Fattori immunologici
- Agenti antineoplastici, immunologici
- Inibitori dell'angiogenesi
- Agenti di modulazione dell'angiogenesi
- Sostanze per la crescita
- Inibitori della crescita
- Agenti antibatterici
- Antibiotici, Antineoplastici
- Agenti antimicotici
- Bevacizumab
- Sirolimo
Altri numeri di identificazione dello studio
- 08-184
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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