- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00100828
Irinotecan in Treating Patients With Metastatic or Inoperable Thyroid Cancer
Phase II Trial of Irinotecan for Treatment of Metastatic Medullary Thyroid Cancer
RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well irinotecan works in treating patients with metastatic or inoperable thyroid cancer.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES:
Primary
- Determine the response rate in patients with metastatic or inoperable locoregional medullary thyroid cancer treated with irinotecan.
Secondary
- Determine the safety and tolerability of this drug in these patients.
OUTLINE: Patients receive irinotecan IV on days 1 and 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Response is assessed after completion of 4 courses. Patients achieving complete response (CR) or partial response (PR) receive 2 additional courses beyond CR or PR. Patients who have stable disease receive up to 12 total courses.
PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Maryland
-
Baltimore, Maryland, Forenede Stater, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
-
-
Michigan
-
Ann Arbor, Michigan, Forenede Stater, 48109-0942
- University of Michigan Comprehensive Cancer Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion
- Histologically confirmed medullary thyroid cancer
- Metastatic or inoperable locoregional disease
- Measurable disease by CT scan
- 18 years and over
- ECOG PS 0-1
Adequate lab functions including:
- Granulocyte count > 1,000/mm^3
- Platelet count > 100,000/mm^3
- Bilirubin < 1.5 mg/dL
- ALT and AST < 2.5 times upper limit of normal
- No unstable or uncompensated hepatic disease
- Creatinine clearance > 60 mL/min
- No unstable or uncompensated renal disease
- Negative pregnancy test
- More than 3 months since prior biologic therapy
- More than 3 months since prior chemotherapy
- No prior radiotherapy to > 25% of bone marrow
- More than 3 months since prior radiotherapy
- Recovered from prior oncologic or other major surgery
- More than 30 days since prior non-approved or investigational drugs
Exclusion:
- Patients with elevated calcitonin levels as the only measurement of disease are not eligible
- Unstable or uncompensated cardiovascular disease
- Unstable or uncompensated respiratory disease
- Pregnant or nursing
- Diarrhea ≥ grade 2 (antidiarrheals allowed)
- Other severe or uncontrolled systemic disease
- Other malignancy within the past 5 years except squamous cell or basal cell skin cancer or cervical cancer
- Illness that would preclude study participation
- Significant clinical disorder or laboratory finding that would preclude study participation
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Irinotecan
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Response Rate
Tidsramme: Every 2 cycles
|
To determine the response rate of this regimen of irinotecan in patients with metastatic MTC
|
Every 2 cycles
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer
- Neoplasmer efter sted
- Sygdomme i det endokrine system
- Neoplasmer i endokrine kirtler
- Skjoldbruskkirtelsygdomme
- Neoplasmer i hoved og hals
- Thyroidneoplasmer
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antineoplastiske midler
- Topoisomerasehæmmere
- Topoisomerase I-hæmmere
- Irinotecan
Andre undersøgelses-id-numre
- J0459
- P30CA006973 (U.S. NIH-bevilling/kontrakt)
- P50CA096784 (U.S. NIH-bevilling/kontrakt)
- JHOC-J0459
- JHOC-04080402
- CDR0000409567 (Anden identifikator: other)
- 04-08-04-02 (Anden identifikator: JHM IRB)
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