Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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.

Further Study Information

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.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Barbara Ann Karmanos Cancer Institute

Patricia M. LoRusso

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00028548
Information obtained from ClinicalTrials.gov on December 14, 2011

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