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Phase I Study of R(+)-XK469 (NSC 698215) Given Daily, Days 1-5, Repeated Every Three Weeks in Patients With Advanced Malignancies


Phase 1
16 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Study of R(+)-XK469 (NSC 698215) Given Daily, Days 1-5, Repeated Every Three Weeks in Patients With Advanced Malignancies


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Patricia M. LoRusso, DO

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000069103

NCT ID:

NCT00028548

Start Date:

January 2002

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201