- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00087217
17-N-Allylamino-17-Demethoxygeldanamycin and Paclitaxel in Treating Patients With Metastatic or Unresectable Solid Tumor
Phase I Study of 17- Allylamino-17 Demethoxygeldanamycin (17-AAG) in Combination With Paclitaxel in Advanced Solid Malignancies
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
OBJECTIVES:
I. Determine the maximum tolerated dose and recommended phase II dose of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) when administered with paclitaxel in patients with metastatic or unresectable solid malignancy.
II. Determine the dose-limiting and non-dose-limiting toxic effects of this regimen in these patients.
III. Determine the pharmacokinetics of this regimen in these patients. IV. Determine tumor response in patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG). Patients receive 17-AAG IV over 1 hour on days 1*, 4, 8, 11, 15 and 18 and paclitaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
NOTE: *17-AAG is not administered on day 1 of course 1. Cohorts of 3-6 patients receive escalating doses of 17-AAG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 6-12 patients are treated at the recommended phase II dose.
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
- University of Pennsylvania Medical Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
Histologically confirmed solid malignancy
- Metastatic or unresectable disease
- Not amenable to standard curative or palliative therapy
- No known brain metastases
- Performance status - ECOG 0-2
- More than 12 weeks
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- WBC ≥ 3,000/mm^3
- AST and ALT ≤ 2.5 times upper limit of normal
- Bilirubin normal
- Creatinine normal
- Creatinine clearance ≥ 60 mL/min
- QTc < 450 msec for male patients (470 msec for female patients)
- LVEF > 40% by MUGA
- No history of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
- No myocardial infarction within the past year
- No New York Heart Association class III or IV congestive heart failure
- No poorly controlled angina
- No history of uncontrolled dysrhythmia or requirement for antiarrhythmic drugs
- No history of congenital long QT syndrome
- No active ischemic heart disease within the past year
- No left bundle branch block
- No other significant cardiac disease
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective double barrier contraception for at least 1 week before, during, and for at least 2 weeks after study participation
- No prior allergy to eggs
- No prior allergic reaction to compounds of similar chemical or biologic composition to 17-AAG or paclitaxel
- No peripheral neuropathy > grade 1
- No concurrent uncontrolled illness
- No active or ongoing infection
- No psychiatric illness or social situation that would preclude study compliance
- No concurrent granulocyte colony-stimulating factors
- Prior paclitaxel allowed
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- No prior 17-N-allylamino-17-demethoxygeldanamycin (17-AAG)
- More than 4 weeks since prior radiotherapy
- No prior radiotherapy that included the heart in the field (e.g., mantle radiotherapy)
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No concurrent therapeutic-dose warfarin for anticoagulation
- No concurrent medications that may prolong QTc interval
- No other concurrent investigational agents
- No other concurrent anticancer agents or therapies
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Treatment (tanespimycin, paclitaxel)
Patients receive 17-AAG IV over 1 hour on days 1*, 4, 8, 11, 15 and 18 and paclitaxel IV over 1 hour on days 1, 8, and 15.
Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
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Korrelative studier
Korrelative studier
Andre navn:
Gitt IV
Andre navn:
Gitt IV
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Phase 2 recommended doses of tanespimycin
Tidsramme: 28 days
|
Tabulated according to the NCI CTC.
|
28 days
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Suresh Ramalingam, University of Pennsylvania Medical Center
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NCI-2012-02610
- U01CA099168 (U.S. NIH-stipend/kontrakt)
- U01CA062502 (U.S. NIH-stipend/kontrakt)
- PCI-03-152
- CDR0000373824 (Registeridentifikator: PDQ (Physician data Query))
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