S-3304 in Treating Patients With Advanced Solid Tumors

This study has been completed.
Information provided by:
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
First received: April 9, 2002
Last updated: March 3, 2011
Last verified: March 2011

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 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Study of S-3304 in Patients With Solid Tumors

Resource links provided by NLM:

Further study details as provided by Roswell Park Cancer Institute:

Study Start Date: October 2001
Study Completion Date: January 2003
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


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


  • 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



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • More than 6 weeks


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


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


  • Creatinine less than 2.0 mg/dL


  • 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


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


  • 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


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


  • No prior significant gastric resection


  • 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

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

Additional Information:
Responsible Party: Patrick Creaven, MD, Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00033566     History of Changes
Other Study ID Numbers: CDR0000069301, RPCI-DS-0120
Study First Received: April 9, 2002
Last Updated: March 3, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:

ClinicalTrials.gov processed this record on April 15, 2014