XK469 in Treating Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00028548
First received: January 4, 2002
Last updated: July 23, 2008
Last verified: July 2004

January 4, 2002
July 23, 2008
January 2002
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Complete list of historical versions of study NCT00028548 on ClinicalTrials.gov Archive Site
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XK469 in Treating Patients With Advanced Solid Tumors
Phase I Study of R(+)-XK469 (NSC 698215) Given Daily, Days 1-5, Repeated Every Three Weeks in Patients With Advanced Malignancies

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.

Interventional
Phase 1
Primary Purpose: Treatment
Unspecified Adult Solid Tumor, Protocol Specific
Drug: R(+)XK469
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00028548
CDR0000069103, WSU-C-2346, NCI-4550, WSU-T-2001
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Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Study Chair: Patricia M. LoRusso, DO Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
July 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP