UCN-01 and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer
Completed · Phase 1
Conditions studied: Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage II Pancreatic Cancer, Stage III Pancreatic Cancer, Stage IV Pancreatic Cancer
In brief
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
Key facts
- Study ID
- NCT00039403
- Run by
- National Cancer Institute (NCI)
- People needed
- 30
- Starts
- 2002-04-01
- Last updated by the study team
- 2013-01-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- M D Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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