SU5416 and Paclitaxel in Treating Patients With Advanced Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006257
Recruitment Status : Completed
First Posted : October 8, 2003
Last Update Posted : January 13, 2010
National Cancer Institute (NCI)
Information provided by:
City of Hope Medical Center

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.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: paclitaxel Drug: semaxanib Phase 1

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase I Trial of SU5416 in Combination With Weekly Paclitaxel in Patients With Advanced Malignancies
Study Start Date : November 2000

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • WHO 0-2

Life expectancy:

  • At least 3 months


  • Absolute neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3


  • SGOT and SGPT less than 2 times upper limit of normal unless due to presence of tumor
  • Bilirubin normal


  • Creatinine no greater than 1.5 mg/dL
  • Creatinine clearance greater than 60 mL/min


  • 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


  • No pulmonary embolism within the past 3 months


  • 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


Biologic therapy:

  • No prior SU5416


  • No prior paclitaxel
  • Greater than 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered

Endocrine therapy:

  • Not specified


  • Greater than 4 weeks since prior radiotherapy and recovered


  • See Disease Characteristics


  • Recovered from any prior investigational agents
  • No other concurrent investigational agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006257

United States, California
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, United States, 91010-3000
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
University of California Davis Cancer Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Study Chair: Przemyslaw W. Twardowski, MD City of Hope Comprehensive Cancer Center Identifier: NCT00006257     History of Changes
Other Study ID Numbers: CDR0000068191
U01CA062505 ( U.S. NIH Grant/Contract )
P30CA033572 ( U.S. NIH Grant/Contract )
First Posted: October 8, 2003    Key Record Dates
Last Update Posted: January 13, 2010
Last Verified: January 2010

Keywords provided by City of Hope Medical Center:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors