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XK469 in Treating Patients With Advanced Solid Tumors
This study has been completed.
First Received: January 4, 2002   Last Updated: July 23, 2008   History of Changes
Sponsor: Barbara Ann Karmanos Cancer Institute
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00028548
  Purpose

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.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: R(+)XK469
Phase I

Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Study of R(+)-XK469 (NSC 698215) Given Daily, Days 1-5, Repeated Every Three Weeks in Patients With Advanced Malignancies

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 2002
Detailed 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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00028548

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Study Chair: Patricia M. LoRusso, DO Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000069103, WSU-C-2346, NCI-4550, WSU-T-2001
Study First Received: January 4, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00028548     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

ClinicalTrials.gov processed this record on November 27, 2009