SU5416 and Paclitaxel in Treating Patients With Advanced Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00006257
First received: September 11, 2000
Last updated: January 11, 2010
Last verified: January 2010
  Purpose

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 Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: paclitaxel
Drug: semaxanib
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Trial of SU5416 in Combination With Weekly Paclitaxel in Patients With Advanced Malignancies

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Study Start Date: November 2000
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006257

Locations
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
Investigators
Study Chair: Przemyslaw W. Twardowski, MD Beckman Research Institute
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00006257     History of Changes
Other Study ID Numbers: CDR0000068191, U01CA062505, P30CA033572, CHNMC-PHI-30, CHNMC-IRB-99098, NCI-T99-0086
Study First Received: September 11, 2000
Last Updated: January 11, 2010
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014