- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00006257
SU5416 and Paclitaxel in Treating Patients With Advanced Cancer
Phase I Trial of SU5416 in Combination With Weekly Paclitaxel in Patients With Advanced Malignancies
RATIONALE: Drugs such as SU5416 may stop the growth of cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining SU5416 with chemotherapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining SU5416 and paclitaxel in treating patients who have advanced cancer.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES:
- Determine the maximum tolerated dose of SU5416 when combined with paclitaxel in patients with advanced malignancies.
- Determine the toxicities and pharmacokinetics of this regimen in these patients.
- Determine the effects of this regimen on a variety of histological and molecular biomarkers of angiogenesis, including in vitro activity assays of endothelial cell proliferation, migration, and invasion.
OUTLINE: This is a dose escalation study of SU5416.
Patients receive SU5416 IV over 1 hour twice weekly during the first week. During subsequent courses, SU5416 is administered on days 1, 4, 8, 11, 15, 18, 22, and 25. Paclitaxel begins on the second week of therapy and is administered IV over 1 hour on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of SU5416 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 24 patients will be accrued for this study within 12-18 months.
Undersøgelsestype
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
California
-
Duarte, California, Forenede Stater, 91010-3000
- Cancer Center and Beckman Research Institute, City of Hope
-
Los Angeles, California, Forenede Stater, 90033-0804
- USC/Norris Comprehensive Cancer Center and Hospital
-
Sacramento, California, Forenede Stater, 95817
- University of California Davis Cancer Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
DISEASE CHARACTERISTICS:
- Histologically or cytologically proven advanced malignancy for which no satisfactory treatment exists
Must have tumor accessible by biopsy
- Minimum of 1 baseline biopsy required
- No brain metastases or primary CNS tumor
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- WHO 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
Hepatic:
- SGOT and SGPT less than 2 times upper limit of normal unless due to presence of tumor
- Bilirubin normal
Renal:
- Creatinine no greater than 1.5 mg/dL
- Creatinine clearance greater than 60 mL/min
Cardiovascular:
- No uncompensated coronary artery disease by ECG or physical examination
- No myocardial infarction or severe unstable/angina within the past 6 months
- No severe peripheral vascular disease associated with diabetes mellitus
- No severe deep vein or arterial thrombosis within the past 3 months
Pulmonary:
- No pulmonary embolism within the past 3 months
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No unstable or severe concurrent medical condition
- No active uncontrolled infection
- No history of allergic reaction to paclitaxel or Cremophor
- No greater than grade 1 peripheral neuropathy
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior SU5416
Chemotherapy:
- No prior paclitaxel
- Greater than 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered
Endocrine therapy:
- Not specified
Radiotherapy:
- Greater than 4 weeks since prior radiotherapy and recovered
Surgery:
- See Disease Characteristics
Other:
- Recovered from any prior investigational agents
- No other concurrent investigational agents
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Przemyslaw W. Twardowski, MD, City of Hope Comprehensive Cancer Center
Datoer for undersøgelser
Studer store datoer
Studiestart
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
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Antineoplastiske midler, fytogene
- Angiogenese-hæmmere
- Angiogenesemodulerende midler
- Vækststoffer
- Væksthæmmere
- Proteinkinasehæmmere
- Paclitaxel
- Semaxinib
Andre undersøgelses-id-numre
- CDR0000068191
- P30CA033572 (U.S. NIH-bevilling/kontrakt)
- U01CA062505 (U.S. NIH-bevilling/kontrakt)
- CHNMC-PHI-30
- CHNMC-IRB-99098
- NCI-T99-0086
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