Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

XK469 in Treating Patients With Advanced Solid Tumors

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Completed 16 and over NCI WSU-C-2346 NCI-4550, WSU-T-2001, 4550, NCT00028548

Objectives

1. Determine the maximum tolerated dose, dose-limiting toxicity, and recommended phase II dose of XK469 in patients with advanced solid tumors.
2. Determine the safety of this drug in these patients.
3. Determine the pharmacokinetics of this drug in these patients.
4. Determine, preliminarily, any anti-tumor activity of this drug in these patients.
5. 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.

Entry 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

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

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/mm³
• Platelet count at least 100,000/mm³

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)

Expected Enrollment

Approximately 25-40 patients will be accrued for this study within 12-15 months.

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.

Trial Contact Information

Trial Lead Organizations

Barbara Ann Karmanos Cancer Institute

Patricia LoRusso, DO, Protocol chair		Ph: 313-576-8716; 800-527-6266

Registry Information
Official Title		Phase I Study of R(+)-XK469 (NSC 698215) Given Daily, Days 1-5, Repeated Every Three Weeks in Patients With Advanced Malignancies
Trial Start Date		2002-01-28
Registered in ClinicalTrials.gov		NCT00028548
Date Submitted to PDQ		2001-10-31
Information Last Verified		2004-07-26
NCI Grant/Contract Number		CA62487

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