S-3304 in Treating Patients With Advanced Solid Tumors

NCT00033566 | Completed Phase 1 DMC

• 2 other identifiers: CDR0000069301RPCI-DS-0120
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

S-3304 DRUG

Eligibility Criteria

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

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

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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Related Publications (1)

• Chiappori AA, Eckhardt SG, Bukowski R, Sullivan DM, Ikeda M, Yano Y, Yamada-Sawada T, Kambayashi Y, Tanaka K, Javle MM, Mekhail T, O'bryant CL, Creaven PJ. A phase I pharmacokinetic and pharmacodynamic study of s-3304, a novel matrix metalloproteinase inhibitor, in patients with advanced and refractory solid tumors. Clin Cancer Res. 2007 Apr 1;13(7):2091-9. doi: 10.1158/1078-0432.CCR-06-1586.

  PMID: 17404091 RESULT

MeSH Terms

Interventions

S 3304

Study Officials

• Patrick J. Creaven, MBBS, PhD

  Roswell Park Cancer Institute

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: April 9, 2002
• First Posted: January 27, 2003
• Study Start: October 1, 2001
• Primary Completion: December 1, 2002
• Study Completion: January 1, 2003
• Last Updated: March 7, 2011

Record last verified: 2011-03

Locations

US (1)