Clinical trial · Interventional
Fluorouracil Plus UCN-01 in Treating Patients With Advanced or Refractory Solid Tumors
A Phase I Study of the Cyclin-Dependent Kinase (CDK)/Protein Kinase C (PKC) Inhibitor UCN-01 (NSC 638850) in Combination With 5-Fluorouracil in Patients With Advanced Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. UCN-01 may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug. PURPOSE: Phase I trial to study the effectiveness of fluorouracil plus UCN-01 in treating patients who have advanced or refractory solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 7-hydroxystaurosporine | Drug | — | UNRESOLVED |
| fluorouracil | Drug | Fluorouracil | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed solid tumor that is refractory to standard therapy or for which no standard therapy exists * Measurable or evaluable disease * No CNS metastasis or primary CNS malignancy PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * WBC greater than 3,500/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 mg/dL * SGOT and SGPT no greater than 2.5 times upper limit of normal Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance greater than 60 mL/min Cardiovascular: * No history of coronary artery disease documented by prior myocardial infarction, angiography, or coronary-artery bypass grafting * No cardiac arrhythmias or congestive heart failure within the past 6 months * Stable atrial fibrillation on standard treatment allowed at discretion of investigator Pulmonary: * DLCO at least 60% of predicted Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 2 months after study * No active serious or uncontrolled infection * HIV negative * No diabetes * No other medical condition that would preclude study PRIOR CONCURRENT THERAPY: * See Disease Characteristics Biologic therapy: * At least 4 weeks since prior immunotherapy and recovered Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered * Prior fluorouracil allowed Endocrine therapy: * Not specified Radiotherapy: * No prior mediastinal radiotherapy * At least 4 weeks since prior radiotherapy and recovered Surgery: * Not specified Other: * No concurrent anticonvulsant medications
References
Publications (0)
Data not yet available