Phase 1
Completed N=19
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
| Outcome | Result | p-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
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.