Clinical trial · Interventional
UCN-01 and Irinotecan in Treating Patients With Advanced Solid Tumors
The Pharmacokinetic and Safety Profile of UCN-01 in Combination With Irinotecan in Solid Tumors (Primarily Lung, Ovarian and GI Cancers)
NCT00047242CI-TRIAL-00003751completedPhase 1ClinicalTrials.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 I trial to study the effectiveness of combining UCN-01 with irinotecan in treating patients who have advanced 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 |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative therapy does not exist or is no longer effective * Gastrointestinal, lung, and ovarian malignancies are given priority * No brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy * More than 3 months 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 (ULN) Renal * Creatinine normal OR * Creatinine clearance at least 60 mL/min Cardiovascular * No symptomatic coronary artery disease * No symptomatic cardiac dysfunction * No symptoms suggestive of coronary artery disease * LVEF at least 50% Pulmonary * No symptomatic pulmonary dysfunction * FEV\_1 greater than 75% of predicted * DLCO greater than 75% of predicted Other * Amylase no greater than 2 times ULN * No other concurrent uncontrolled illness * No ongoing or active infection * No psychiatric illness or social situation that would preclude study compliance * No diabetes mellitus or random glucose more than 200 mg/dL * No prior allergic reaction attributed to compounds of similar biological or chemical composition to UCN-01 or irinotecan (including rash and systemic allergic reaction causing hypotension and respiratory distress) * No chronic diarrhea (more than 5 stools/day) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception for 14 days before, during, and for at least 30 days after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * Prior UCN-01 and irinotecan allowed Endocrine therapy * Not specified Radiotherapy * At least 4 weeks since prior radiotherapy and recovered * No prior mediastinal radiation Surgery * Not specified Other * At least 14 days since prior warfarin * No concurrent warfarin unless required for maintaining patency of existing, permanent IV catheters * No concurrent commercial or other investigational anticancer agents or therapies * No concurrent combination antiretroviral therapy for HIV-positive patients
References
Publications (1)
- RESULTJimeno A, Rudek MA, Purcell T, Laheru DA, Messersmith WA, Dancey J, Carducci MA, Baker SD, Hidalgo M, Donehower RC. Phase I and pharmacokinetic study of UCN-01 in combination with irinotecan in patients with solid tumors. Cancer Chemother Pharmacol. 2008 Mar;61(3):423-33. doi: 10.1007/s00280-007-0485-9. Epub 2007 Apr 12. PMID 17429623