XK469 in Treating Patients With Advanced Solid Tumors

Barbara Ann Karmanos Cancer Institute

Status and phase

Completed

Phase 1

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Treatments

Drug: R(+)XK469

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00028548

WSU-T-2001

P30CA022453 (U.S. NIH Grant/Contract)

WSU-C-2346

U01CA062487 (U.S. NIH Grant/Contract)

NCI-4550

CDR0000069103

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 XK469 in treating patients who have advanced solid tumors.

Full description

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.

Enrollment

22 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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: