XK469 in Treating Patients With Advanced Solid Tumors

Barbara Ann Karmanos Cancer Institute22 enrolled

Overview

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 XK469 in treating patients who have advanced solid tumors.

OBJECTIVES: * Determine the maximum tolerated dose, dose-limiting toxicity, and recommended phase II dose of XK469 in patients with advanced solid tumors. * Determine the safety of this drug in these patients. * Determine the pharmacokinetics of this drug in these patients. * Determine, preliminarily, any anti-tumor activity of this drug in these patients. * Determine the drug metabolism, drug interaction potential, molecular and cellular predictors of efficacy and toxicity, and clinical confirmation of molecular responses in patients treated with this drug. OUTLINE: This is a dose-escalation study. Patients receive XK469 IV over 20 minutes on days 1-5. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of XK469 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of the first 6 patients experience dose-limiting toxicity. Once the MTD is determined, up to 15 patients are treated at that dose. Patients in the expanded MTD cohort also receive oral NovaSoy® soybean extract twice daily for the study duration. Patients are followed every 4 weeks. PROJECTED ACCRUAL: Approximately 25-40 patients will be accrued for this study within 12-15 months.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

R(+)XK469DRUG

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-hematological cancer that is unresponsive to available therapies or for which there is no known effective treatment * Measurable or evaluable disease * Clinical or radiological evidence of disease required * No active brain metastases PATIENT CHARACTERISTICS: Age: * 16 and over Performance status: * ECOG 0-2 Life expectancy: * At least 3 months Hematopoietic: * Absolute neutrophil count at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 mg/dL * ALT and AST no greater than 2.5 times upper limit of normal Renal: * Creatinine less than 1.5 mg/dL Cardiovascular: * Ejection fraction at least 50% * No significant arrhythmias * No congestive heart failure Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No dementia or altered mental status * No known HIV infection * No active infection * No other serious uncontrolled medical disorder that would preclude study participation * No known allergies to soy products, rice flour, or gelatin (if receiving study dietary soy supplementation) PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy * No concurrent prophylactic colony-stimulating factors Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) * Prior taxanes allowed * No other concurrent chemotherapy Endocrine therapy: * No concurrent hormonal therapy except hormone replacement therapy or medication used to maintain castrate status for patients with progressive hormone-refractory prostate cancer Radiotherapy: * At least 4 weeks since prior radiotherapy * No prior radiotherapy to more than 25% of bone marrow-containing areas * No concurrent radiotherapy Surgery: * Not specified Other: * At least 4 weeks since prior investigational agents * No other concurrent experimental anticancer therapy

Locations (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Data from ClinicalTrials.gov

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