SU5416 and Paclitaxel in Treating Patients With Advanced Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: City of Hope Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel; Semaxinib

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