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S-3304 in Treating Patients With Advanced Solid Tumors
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Roswell Park Cancer Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00033566
  Purpose

RATIONALE: S-3304 may stop or slow the growth of solid tumors by stopping blood flow to the tumor.

PURPOSE: Phase I trial to study the effectiveness of S-3304 in treating patients who have solid tumors.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: S-3304
Phase I

MedlinePlus related topics: Cancer
Drug Information available for: S 3304
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I Study of S-3304 in Patients With Solid Tumors

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 2001
Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose and safety profile of S-3304 in patients with advanced solid tumors.
  • Determine the pharmacokinetic profile of this drug in these patients.
  • Estimate the starting dose of this drug for subsequent phase II efficacy studies.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive oral S-3304 twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 6-8 patients receive escalating doses of S-3304 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 3 of 8 patients experience dose-limiting toxicity.

Patients are followed at 30 days.

PROJECTED ACCRUAL: A total of 6-28 patients will be accrued for this study within 1 year.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed solid tumor that failed to respond or relapsed after prior therapy or for which no standard therapy exists
  • Biopsy-accessible lesion
  • No brain metastasis unless clinically stable and off therapy

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • More than 6 weeks

Hematopoietic:

  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9.0 g/dL

Hepatic:

  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • Transaminases less than 2.5 times ULN

Renal:

  • Creatinine less than 2.0 mg/dL

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 30 days after study
  • Able to tolerate oral medication
  • HIV negative
  • No AIDS
  • No serious underlying gastrointestinal disorders (e.g., recurrent vomiting or inflammatory bowel disease)
  • No other serious concurrent illness

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior immunotherapy
  • Concurrent stable doses of epoetin alfa are allowed during the second and subsequent courses
  • No other concurrent immunotherapy

Chemotherapy:

  • At least 4 weeks since prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy:

  • At least 4 weeks since prior hormonal therapy
  • Concurrent stable doses of steroids for prostate cancer are allowed during the second and subsequent courses
  • No concurrent hormonal therapy

Radiotherapy:

  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery:

  • No prior significant gastric resection

Other:

  • Recovered from prior therapy
  • At least 4 weeks since other prior investigational antitumor drugs
  • No other concurrent investigational antitumor drugs
  • Concurrent stable doses of bisphosphonates, cyclo-oxygenase-2 inhibitors, and non-steroidal anti-inflammatory drugs are allowed during the second and subsequent study courses
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00033566

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Study Chair: Patrick J. Creaven, MBBS, PhD Roswell Park Cancer Institute
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Study ID Numbers: CDR0000069301, RPCI-DS-0120, SHIONOGI-0110P1416, NCI-G02-2058
Study First Received: April 9, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00033566  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

ClinicalTrials.gov processed this record on January 16, 2009