- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
New York
-
Bronx, New York, Forenede Stater, 10461
- Albert Einstein Comprehensive Cancer Center
-
New York, New York, Forenede Stater, 10021
- New York Presbyterian Hospital - Cornell Campus
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- VION-CLI-015
- CDR0000068591 (Registry Identifier: PDQ (Physician Data Query))
- AECM-1200012380
- NCI-V01-1658
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