Phase I Trial of SU5416 in Combination With Weekly Paclitaxel in Patients With Advanced Malignancies
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Phase I Trial of SU5416 in Combination With Weekly Paclitaxel in Patients With Advanced Malignancies
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Przemyslaw W. Twardowski, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Beckman Research Institute
Authority:
United States: Federal Government
Study ID:
CDR0000068191
NCT ID:
NCT00006257
Start Date:
November 2000
Completion Date:
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
Name | Location |
|---|---|
| Cancer Center and Beckman Research Institute, City of Hope | Duarte, California 91010-3000 |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
| University of California Davis Cancer Center | Sacramento, California 95817 |
