- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT00016874
3-AP Plus Cisplatin and Paclitaxel in Treating Patients With Advanced or Metastatic Cancer
A Phase I Study Of 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone (3-AP, Triapine) In Combination With Cisplatin And Paclitaxel In Patients With Advanced And Metastatic Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining 3-AP, cisplatin, and paclitaxel in treating patients who have advanced or metastatic cancer.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
OBJECTIVES:
- Determine the safety and tolerability of 3-AP, cisplatin, and paclitaxel in patients with advanced or metastatic cancer.
- Determine the toxic effects of this regimen in these patients.
- Determine the maximum tolerated dose and recommended phase II dose of this regimen in these patients.
- Determine the pharmacokinetic parameters of this regimen in these patients.
- Determine the tumor response in patients treated with this regimen.
OUTLINE: This is a dose-escalation study.
Patients receive 3-AP IV continuously over 96 hours on days 1-4 and paclitaxel IV over 3 hours followed by cisplatin IV over 1 hour on day 3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 1 additional course of therapy after documented CR. Patients with partial response or stable disease may receive therapy for up to 6 months.
Cohorts of 1-6 patients receive escalating doses of 3-AP, paclitaxel, and cisplatin 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.
PROJECTED ACCRUAL: Approximately 25-30 patients will be accrued for this study.
Typ studiów
Faza
- Faza 1
Kontakty i lokalizacje
Lokalizacje studiów
-
-
New York
-
Bronx, New York, Stany Zjednoczone, 10461
- Albert Einstein Comprehensive Cancer Center
-
New York, New York, Stany Zjednoczone, 10021
- New York Presbyterian Hospital - Cornell Campus
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
DISEASE CHARACTERISTICS:
Histologically confirmed progressive advanced or metastatic cancer
- Failed 1 or more prior standard therapies for disease OR
- Unlikely to respond to any currently available therapies
- Measurable or evaluable disease
No active CNS metastases
- Previously treated CNS metastases allowed if no evidence of new CNS metastases and stable for at least 2 months
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-1
Life expectancy:
- More than 3 months
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10 g/dL (transfusion allowed)
- No active bleeding or coagulation disorder (occult blood for gastrointestinal cancer allowed)
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- ALT/AST no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
- Alkaline phosphatase no greater than 3 times ULN (5 times ULN if liver metastases present)
- Albumin at least 3.0 g/dL
- PT/PTT no greater than 1.5 times ULN
Renal:
- Creatinine no greater than 1.5 mg/dL
Cardiovascular:
- No active heart disease
- No myocardial infarction within the past 3 months
- No symptomatic coronary artery disease, heart block, or uncontrolled congestive heart failure
Pulmonary:
- No moderate to severe compromise in pulmonary function
Other:
- No mental deficits and/or psychiatric history that would preclude study
- No active infection
- No pre-existing severe hearing impairment
- No pre-existing grade 2 or greater neuropathy
- No prior severe allergic reaction to study drugs
- No other life-threatening illness
- No chronic toxic effects from prior chemotherapy greater than grade I
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 18 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Concurrent hematopoietic growth factors allowed except if used prophylactically during first course of study therapy
Chemotherapy:
- More than 3 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered
- More than 6 months since prior combination cisplatin and paclitaxel
- Prior cisplatin or paclitaxel as single agents allowed
- Prior 3-AP allowed
Endocrine therapy:
- Not specified
Radiotherapy:
- More than 3 weeks since prior radiotherapy and recovered
- Concurrent radiotherapy to a single site of progressive disease allowed if site requires treatment within the first course of study therapy
Surgery:
- Not specified
Other:
- More than 3 weeks since any therapy for malignancy and recovered
- No other concurrent investigational drugs without consent of sponsor
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- VION-CLI-015
- CDR0000068591 (Identyfikator rejestru: PDQ (Physician Data Query))
- AECM-1200012380
- NCI-V01-1658
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