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Phase 1 Completed N=19 Treatment

Benzoylphenylurea in Treating Patients With Advanced Solid Tumors

Unspecified Adult Solid Tumor, Protocol Specific
Source: ClinicalTrials.gov NCT00016354 ↗
Enrolled (actual)
19
Serious AEs
5.3%
Results posted
Aug 2012
Primary outcomePrimary: Determine Maximum Tolerated Dose of BPU — 150 milligrams (mg)

Summary

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 benzoylphenylurea in treating patients who have advanced solid tumors.

Outcome Measures

OutcomeResultp-value
PRIMARY
Determine Maximum Tolerated Dose of BPU
150
SECONDARY
Number of Patients With Adverse Events
SECONDARY
Area Under the Plasma Concentration Versus Time Curve (AUC) of BPU
SECONDARY
Test for Antitumor Activity in Blood and Tissue

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed malignancy
  • Metastatic or unresectable
  • No effective standard curative or palliative measures exist
  • No known CNS or brain metastasis

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin normal
  • SGOT/SGPT normal

Renal:

  • Creatinine normal
  • Creatinine clearance at least 60 mL/min

Cardiovascular:

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No uncontrolled ventricular arrhythmia
  • No myocardial infarction within the past 3 months
  • No superior vena cava syndrome

Neurologic:

  • No grade 1 or greater peripheral neuropathy
  • No uncontrolled major seizure disorder
  • No spinal cord compression

Other:

  • No active serious infection requiring IV antibiotics
  • No concurrent uncontrolled illness
  • No concurrent unstable or serious medical condition
  • No chronic diarrhea or malabsorption
  • No history of allergic reactions to compounds similar in chemical or biological composition to benzoylphenylurea
  • No psychiatric illness or social situation that would preclude study compliance
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent immunotherapy
  • No concurrent growth factors during first 2 courses of study
  • Concurrent epoetin alfa allowed

Chemotherapy:

  • At least 28 days since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent hormonal therapy

Radiotherapy:

  • At least 28 days since prior large-field radiotherapy
  • Prior palliative radiotherapy for painful bone metastases allowed
  • No concurrent radiotherapy, including palliative or whole-brain radiotherapy for CNS disease

Surgery:

  • At least 28 days since prior major surgery

Other:

  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational or commercial agents or therapies for the malignancy
  • No other concurrent investigational agents
  • Concurrent bisphosphonates allowed if bone metastases are not only site of measurable or evaluable disease
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00016354). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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