SU5416 and Paclitaxel in Treating Patients With Advanced Cancer

NCT00006257 | Completed Phase 1

• 6 other identifiers: CDR0000068191U01CA062505P30CA033572CHNMC-PHI-30CHNMC-IRB-99098NCI-T99-0086
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

paclitaxel DRUG

semaxanib DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Cancer Center and Beckman Research Institute, City of Hope

Duarte, California, 91010-3000, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033-0804, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Interventions

Paclitaxel; Semaxinib

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Przemyslaw W. Twardowski, MD

  City of Hope Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 11, 2000
• First Posted: October 8, 2003
• Study Start: November 1, 2000
• Last Updated: January 13, 2010

Record last verified: 2010-01

Locations

US (3)