Phase I and Pharmacokinetics Study to Determine the Safety of CHS 828 in Patients With a Solid Tumor on a Single Oral Dose Repeated Every 3 Weeks
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Phase I and Pharmacokinetics Study to Determine the Safety of CHS 828 in Patients With a Solid Tumor on a Single Oral Dose Repeated Every 3 Weeks
OBJECTIVES:
- Determine the maximum tolerated dose of oral CHS 828 in patients with solid tumors.
- Determine the qualitative and quantitative toxic effects of this regimen in these
patients.
- Determine a safe dose of this regimen for phase II evaluation.
- Determine the pharmacokinetic profile of this regimen in these patients.
- Determine any antitumor activity in these patients.
OUTLINE: Patients receive oral CHS 828 every 3 weeks. Treatment continues for at least 2
courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of CHS 828 until the maximum tolerated dose
(MTD) is reached. The MTD is defined as the dose at which 2 of 6 patients experience dose
limiting toxicity.
Patients are followed for up to 4 weeks.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 12 months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed solid tumor not amenable to standard
therapy
- No symptomatic brain or leptomeningeal involvement
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- WHO 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- WBC at least 4,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin less than 1.5 mg/dL
- Other liver function tests no greater than 2 times upper limit of normal (unless
related to liver metastases)
Renal:
- Creatinine no greater than 1.4 mg/dL
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No active bacterial infection
- No other nonmalignant disease
- No alcoholism, drug addiction, or psychiatric disorders
- Able to take oral medication
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior immunotherapy
Chemotherapy:
- At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas)
- No other concurrent chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 4 weeks since prior radiotherapy (6 weeks since extensive radiotherapy)
- No concurrent radiotherapy (except palliative radiotherapy)
Surgery:
- Not specified
Other:
- No other concurrent investigational drugs
- No other concurrent antitumor drugs
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Thomas Cerny, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Kantonsspital St. Gallen
Authority:
United States: Federal Government
Study ID:
EORTC-16985
NCT ID:
NCT00003979
Start Date:
April 1999
Completion Date:
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- Neoplasms
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