Mode
Text Size
Log in / Sign up
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.

Back to search