|
UCN-01 and Fluorouracil in Treating Patients With Metastatic Pancreatic Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on UCN-01 and Fluorouracil in Treating Patients With Metastatic Pancreatic Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. UCN-01 and Fluorouracil in Treating Patients With Metastatic Pancreatic Cancer Clinical research trials and UCN-01 and Fluorouracil in Treating Patients With Metastatic Pancreatic Cancer medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like UCN-01 and Fluorouracil in Treating Patients With Metastatic Pancreatic Cancer. UCN-01 and Fluorouracil in Treating Patients With Metastatic Pancreatic Cancer Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a UCN-01 and Fluorouracil in Treating Patients With Metastatic Pancreatic Cancer clinical trial. Participants frequently obtain the most expert healthcare available for their UCN-01 and Fluorouracil in Treating Patients With Metastatic Pancreatic Cancer condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "U" Clinical Trials Conditions > UCN-01 and Fluorouracil in Treating Patients With Metastatic Pancreatic Cancer  UCN-01 and Fluorouracil in Treating Patients With Metastatic Pancreatic Cancer
UCN-01 and Fluorouracil in Treating Patients With Metastatic Pancreatic Cancer
For Condition: adenocarcinoma of the pancreas,stage 4B pancreatic cancer,recurrent pancreatic cancer
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: 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 metastaticpancreatic cancer that has not responded to treatment with gemcitabine.
Details: OBJECTIVES: - Determine the response rate, time to progression, and overall survival of patients with gemcitabine-refractory metastatic pancreatic cancer treated with UCN-01 and fluorouracil. - Determine the toxicity of this regimen in these patients. OUTLINE: Patients receive fluorouracil IV over 24 hours on days 1, 8, 15, and 22. Patients also receive UCN-01 IV continuously over 72 hours (course 1 only) beginning on day 2. In subsequent courses, UCN-01 is infused over 36 hours. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 3-13 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GarySchwartz, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Gary Schwartz 212-639-8324
Additional Information:
Study ID Numbers: CDR0000257125; NCI-5509,MSKCC-02049
Study Start Date:
Record last reviewed: November 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00045747
Other Adenocarcinoma Of The Pancreas Studies:
1. Nitrocamptothecin Compared With Other Chemotherapy in Treating Patients With Recurrent or Refractory Cancer of the Pancreas
2. Bevacizumab With or Without Docetaxel in Treating Patients With Previously Treated Metastatic Pancreatic Cancer
3. Gemcitabine and Radiation Therapy Compared With Observation in Treating Patients Who Have Undergone Surgery for Pancreatic Cancer
4. Nitrocamptothecin or Fluorouracil in Treating Patients With Recurrent or Refractory Pancreatic Cancer
5. Fluorouracil, Gemcitabine, and Radiation Therapy in Treating Patients With Cancer of the Pancreas
Related Studies:
Other adenocarcinoma of the pancreas Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
UCN-01 and Fluorouracil in Treating Patients With Metastatic Pancreatic Cancer
|
|
|
|
|
|
|
|
