Lurtotecan Liposome in Treating Patients With Advanced Solid Tumors
A Phase I Study of NX211 Given as an IV Infusion Days 1, 2 and 3 Every 3 Weeks in Patients With Solid Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of lurtotecan liposome in treating patients who have advanced solid tumors.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
OBJECTIVES: I. Determine the maximum tolerated dose (MTD) and the future dose of lurtotecan liposome in patients with advanced solid tumors. II. Assess the toxicity and pharmacokinetics of this treatment regimen in this patient population. III. Assess the response to this regimen by patients with measurable disease.
OUTLINE: This is a dose escalation, multicenter study. Patients receive lurtotecan liposome (NX211) IV over 30 minutes on days 1, 2, and 3. Courses are repeated every 3 weeks. Treatment continues for up to 6 courses in the absence of unacceptable toxicity or disease progression. The dose of NX211 is escalated in cohorts of 3-6 patients until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed at 4 weeks and every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 20-25 patients will be accrued for this study within 12-15 months.
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E6
- BC Cancer Agency
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Ontario
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Hamilton, Ontario, Canada, L8V 5C2
- Cancer Care Ontario-Hamilton Regional Cancer Centre
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced solid tumors that are unresponsive to existing therapy and for which no curative therapy exists Evidence of disease other than tumor marker elevation No untreated CNS metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) AST and ALT no greater than 2.5 times ULN (no greater than 5 times ULN for liver metastases) Renal: Creatinine no greater than upper limit of normal Cardiovascular: Not specified Pulmonary: Not specified Other: No prior malignancy within past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective contraception No active or uncontrolled infection No other serious illness or medical condition No known hypersensitivity to systemic liposomal formulation or any drug chemically related to study drug
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No greater than 3 prior chemotherapy regimens (adjuvant and metastatic) At least 3 weeks since prior adjuvant and metastatic chemotherapy (6 weeks for nitrosoureas or mitomycin and 4 weeks for carboplatin or other experimental anti cancer drugs) and recovered At least 1 year since prior high dose chemotherapy with bone marrow or stem cell support No other concurrent chemotherapy Endocrine therapy: Prior hormonal therapy allowed No concurrent hormonal therapy Radiotherapy: No prior radiotherapy to greater than 25% of bone marrow At least 4 weeks since prior radiotherapy, except for low dose myelosupressive radiotherapy, and recovered Concurrent palliative radiotherapy allowed Surgery: Not specified Other: At least 4 weeks since prior experimental drug or anticancer therapy No other concurrent investigational or anticancer therapy
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Goetz AD, Hammond LA, Hao D, et al.: A phase I and pharmacokinetic (PK) study of NX211 (liposomal lurtotecan) administered weekly x 4 every 6 weeks in patients with advanced solid tumors. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-388, 2002.
- Hamilton M, Wolf J, Demetri GD, et al.: Phase I pharmacokinetics of NX211 (liposomal lurtotecan) in patients with solid tumors. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-357, 2002.
- Gelmon K, Hirte H, Fisher B, Walsh W, Ptaszynski M, Hamilton M, Onetto N, Eisenhauer E. A phase 1 study of OSI-211 given as an intravenous infusion days 1, 2, and 3 every three weeks in patients with solid cancers. Invest New Drugs. 2004 Aug;22(3):263-75. doi: 10.1023/B:DRUG.0000026252.86842.e2.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
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
- I123
- CAN-NCIC-IND123 (Annen identifikator: PDQ)
- NEXSTAR-110-02 (Annen identifikator: Nexstar)
- CDR0000067060 (Annen identifikator: PDQ)
Plan for individuelle deltakerdata (IPD)
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