CHS 828 in Treating Patients With Solid Tumors

European Organisation for Research and Treatment of Cancer (EORTC)

Status and phase: Withdrawn; Phase 1

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Treatments: Drug: CHS 828

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00003979

EORTC-16985

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of CHS 828 in treating patients who have solid tumors.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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