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A Phase I Study of S-3304 in Patients With Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I Study of S-3304 in Patients With Solid Tumors


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Patrick J. Creaven, MBBS, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000069301

NCT ID:

NCT00033566

Start Date:

October 2001

Completion Date:

January 2003

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263