Clinical trial · Interventional
UCN-01 and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer
A Phase I Study Of UCN-01 In Combination With Gemcitabine In Unresectable Or Metastatic Pancreatic Carcinoma
NCT00039403CI-TRIAL-00009043completedPhase 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)
Phase I trial to study the effectiveness of combining UCN-01 with gemcitabine in treating patients who have unresectable or metastatic pancreatic cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. UCN-01 may help gemcitabine kill more cancer cells by making tumor cells more sensitive to the drug
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Pancreas | Pancreatic Adenocarcinoma | ALIAS | 0.90 |
| Recurrent Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 7-hydroxystaurosporine | Drug | — | UNRESOLVED |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (UCN-01, gemcitabine hydrochloride)
- description
- Patients receive gemcitabine IV over 1-2 hours on days 1 and 8 followed by UCN-01 IV over 3 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Sequential dose escalation of UCN-01 is followed by sequential dose escalation of gemcitabine. Cohorts of 3-6 patients receive escalating doses of UCN-01 and then gemcitabine until the maximum tolerated dose (MTD) of the combination is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, at least 6 patients are treated at the recommended phase II dose.
- interventionNames
- Drug: 7-hydroxystaurosporine
- Drug: gemcitabine hydrochloride
- Other: pharmacological study
- Other: laboratory biomarker analysis
Primary outcomes (3)
- measure
- Incidence of toxicity
- timeFrame
- Up to 4 years
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed unresectable or metastatic adenocarcinoma of the pancreas * Unidimensionally measurable disease * At least 20 mm by conventional techniques * At least 10 mm by spiral CT scan * Tumor lesions in a previously irradiated area are not considered measurable * No known brain metastases * Patients with signs or symptoms of CNS metastasis at any time during screening must have a negative CT scan or MRI of the brain * Performance status - ECOG 0-2 * Performance status - Karnofsky 60-100% * More than 3 months * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count greater than 100,000/mm\^3 * Bilirubin no greater than 1.5 mg/dL * ALT and AST no greater than 2.5 times upper limit of normal * Creatinine normal * Creatinine clearance at least 60 mL/min * No prior coronary artery disease * No symptomatic cardiac dysfunction * No prior myocardial infarction * No active angina (even if controlled by medication) * No positive stress test * No uncontrolled arrhythmia * Left ventricular ejection fraction at least 45% * Patients with symptoms suggestive of coronary artery disease or arrhythmia must have no evidence of cardiac pathology * No symptomatic pulmonary dysfunction * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation * No prior allergic reactions attributed to compounds of similar chemical or biological composition to UCN-01 or other study agents * No insulin-dependent diabetes mellitus * No other concurrent uncontrolled illness * No ongoing or active infections * No concurrent psychiatric illness * No other active malignancy * No other solid tumor within the past 5 years except neoplasia in situ or nonmelanomatous skin cancer * No social situations that would preclude study compliance * No concurrent over-the-counter biologics * No concurrent growth factors during the first study course * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * No more than 2 prior chemotherapy regimens (e.g., gemcitabine and/or experimental agents) alone or in combination with radiotherapy as neoadjuvant or adjuvant therapy for resectable, unresectable, or metastatic disease * See Chemotherapy * At least 6 weeks since prior radiotherapy and recovered * Prior radiotherapy directed only at the primary tumor bed allowed * No prior radiotherapy to the mediastinum, pelvis, lower spine, or more than 20% of bone marrow * At least 4 weeks since prior major surgery * At least 4 weeks since prior investigational agents * Concurrent enrollment in non-therapy trials (e.g., quality of life) allowed * No concurrent herbal remedies * No concurrent treatment for another active malignancy * No concurrent warfarin for anticoagulation * No concurrent combination antiretroviral therapy for HIV-positive patients * No other concurrent investigational or commercial anticancer agents or therapies
References
Publications (0)
Data not yet available
No reference posted for this study.