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Home > "U" Clinical Trials Conditions > UCN-01 and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer  UCN-01 and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer
UCN-01 and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer
For Condition: stage 2 pancreatic cancer,stage 4B pancreatic cancer,stage 4A pancreatic cancer,recurrent pancreatic cancer,adenocarcinoma of the pancreas,stage 3 pancreatic cancer
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: 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. PURPOSE: Phase I trial to study the effectiveness of combining UCN-01 with gemcitabine in treating patients who have unresectable or metastaticpancreatic cancer.
Details: OBJECTIVES: - Determine the safety, toxicity profile, and maximum tolerated dose of UCN-01 and gemcitabine in patients with unresectable or metastatic adenocarcinoma of the pancreas. - Characterize the pharmacokinetic profile of this regimen in these patients. - Correlate various surrogate measurements of UCN-01 with intracellular concentrations in these patients. - Determine the recommended phase II dose of this regimen in these patients. - Determine the frequency, extent, and duration of any tumor responses in patients treated with this regimen. - Correlate serum alpha-1 acid glycoprotein levels in these patients with the pharmacokinetics and toxicity of UCN-01. OUTLINE: This is a dose-escalation study. 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. PROJECTED ACCRUAL: Approximately 6-30 patients will be accrued for this study within 2-15 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed unresectable or metastatic adenocarcinoma of the pancreas - Unidimensionally measurable disease - At least 20 mm by conventional techniques OR - 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 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 greater than 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 mg/dL - ALT and AST no greater than 2.5 times upper limit of normal Renal: - Creatinine normal OR - Creatinine clearance at least 60 mL/min Cardiovascular: - 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 Pulmonary: - No symptomatic pulmonary dysfunction Other: - 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 PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent over-the-counter biologics - No concurrent growth factors during the first study course Chemotherapy: - 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 Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - 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 Surgery: - See Disease Characteristics - At least 4 weeks since prior major surgery Other: - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LinusHo, Study Chair, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Linus Ho 713-792-2828
Additional Information:
Study ID Numbers: CDR0000069380; NCI-5510,MDA-DM-01553
Study Start Date:
Record last reviewed: July 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00039403
Other Stage 3 Pancreatic Cancer Studies:
1. Bevacizumab With or Without Docetaxel in Treating Patients With Previously Treated Metastatic Pancreatic Cancer
2. Glufosfamide With or Without Hydration in Treating Patients With Advanced Pancreatic Cancer
3. Gemcitabine and Monoclonal Antibody Therapy in Treating Patients With Metastatic Cancer of the Pancreas
4. Gemcitabine With or Without Exatecan Mesylate in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
5. Gemcitabine With or Without Erlotinib in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer
Related Studies:
Other stage 3 pancreatic cancer Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
UCN-01 and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer
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