S-3304 in Treating Patients With Advanced Solid Tumors

NCT ID: NCT00033566

Last Updated: 2011-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-10-31
• Study Completion Date: 2003-01-31

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.

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Primary Study Purpose: TREATMENT

Interventions

S-3304

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Roswell Park Cancer Institute

Principal Investigators

Patrick J. Creaven, MBBS, PhD

Role: STUDY_CHAIR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 17404091 (View on PubMed)

Other Identifiers

RPCI-DS-0120

Identifier Type: -

Identifier Source: secondary_id

CDR0000069301

Identifier Type: -

Identifier Source: org_study_id