SU5416 and Paclitaxel in Treating Patients With Advanced Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00006257
• Date of registration: 11/09/2000
• Primary sponsor: City of Hope Medical Center
• Public title: SU5416 and Paclitaxel in Treating Patients With Advanced Cancer
• Scientific title: Phase I Trial of SU5416 in Combination With Weekly Paclitaxel in Patients With Advanced Malignancies
• Date of first enrolment: November 2000
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00006257
• Study type: Interventional
• Study design: Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Przemyslaw W. Twardowski, MD
• Affiliation: Beckman Research Institute

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Unspecified Adult Solid Tumor, Protocol Specific

Intervention(s)

Drug: paclitaxel

Drug: semaxanib

Secondary ID(s)

CDR0000068191

CHNMC-IRB-99098

CHNMC-PHI-30

NCI-T99-0086

P30CA033572

U01CA062505

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)