Clinical trial · Interventional
UCN-01 and Fluorouracil in Treating Patients With Metastatic Pancreatic Cancer
Phase II Study of UCN-01 in Combination With Fluorouracil in Advanced Pancreatic Cancer
NCT00045747CI-TRIAL-00010963completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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: UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining UCN-01 with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining UCN-01 with fluorouracil in treating patients who have metastatic pancreatic cancer that has not responded to treatment with gemcitabine.
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 |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
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 or cytologically confirmed adenocarcinoma of the pancreas * Progressive disease after gemcitabine-based chemotherapy for metastatic disease * At least 1 unidimensionally measurable metastatic lesion * At least 20 mm by conventional techniques OR * At least 10 mm by spiral CT scan * Primary disease site is not considered a measurable lesion * No known brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 OR * Karnofsky 70-100% Life expectancy * More than 8 weeks Hematopoietic * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin normal * AST/ALT no greater than 2.5 times upper limit of normal Renal * Creatinine normal OR * Creatinine clearance at least 60 mL/min Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac tachyarrhythmia Pulmonary * No symptomatic chronic obstructive pulmonary disease * No pulmonary embolism within the past 6 months Other * No prior allergic reactions to compounds of similar chemical or biological composition to UCN-01 or other agents used in this study * No diabetes mellitus uncontrolled by insulin or oral hypoglycemic agents * No uncontrolled concurrent illness * No ongoing or active infection * No psychiatric illness or social situation that would preclude study * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception before, during, and for 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent immunotherapy Chemotherapy * See Disease Characteristics * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * No more than 1 prior chemotherapy regimen for metastatic or recurrent disease * No prior fluorouracil in the adjuvant or inoperable, locally advanced setting (except as a radiosensitizer) * No other concurrent chemotherapy Endocrine therapy * Not specified Radiotherapy * More than 4 weeks since prior radiotherapy and recovered * No prior mediastinal irradiation * No concurrent radiotherapy Surgery * Not specified Other * No prior UCN-01 or other cyclin-dependent kinase inhibitors * No concurrent combination antiretroviral therapy for HIV-positive patients * No other concurrent investigational or commercial anticancer agents or therapies * No concurrent anticonvulsant medications
References
Publications (0)
Data not yet available
No reference posted for this study.