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Flavopiridol Plus Radiation Therapy Followed By Gemcitabine in Treating Patients With Locally Advanced, Unresectable Pancreatic Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Flavopiridol Plus Radiation Therapy Followed By Gemcitabine in Treating Patients With Locally Advanced, Unresectable Pancreatic Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Flavopiridol Plus Radiation Therapy Followed By Gemcitabine in Treating Patients With Locally Advanced, Unresectable Pancreatic Cancer Clinical research trials and Flavopiridol Plus Radiation Therapy Followed By Gemcitabine in Treating Patients With Locally Advanced, Unresectable Pancreatic Cancer medical trials occur in many of places across 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 generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Flavopiridol Plus Radiation Therapy Followed By Gemcitabine in Treating Patients With Locally Advanced, Unresectable Pancreatic Cancer. Flavopiridol Plus Radiation Therapy Followed By Gemcitabine in Treating Patients With Locally Advanced, Unresectable Pancreatic Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Flavopiridol Plus Radiation Therapy Followed By Gemcitabine in Treating Patients With Locally Advanced, Unresectable Pancreatic Cancer clinical trial. Participants oftentimes recieve the finest healthcare available for their Flavopiridol Plus Radiation Therapy Followed By Gemcitabine in Treating Patients With Locally Advanced, Unresectable Pancreatic Cancer condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "F" Clinical Trials Conditions > Flavopiridol Plus Radiation Therapy Followed By Gemcitabine in Treating Patients With Locally Advanced, Unresectable Pancreatic Cancer  Flavopiridol Plus Radiation Therapy Followed By Gemcitabine in Treating Patients With Locally Advanced, Unresectable Pancreatic Cancer
Flavopiridol Plus Radiation Therapy Followed By Gemcitabine in Treating Patients With Locally Advanced, Unresectable Pancreatic Cancer
For Condition: recurrent pancreatic cancer,adenocarcinoma of the pancreas,stage 4A pancreatic cancer,stage 3 pancreatic cancer,stage 2 pancreatic cancer
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy work different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Flavopiridol may make the tumor cells more sensitive to radiation therapy. PURPOSE: Phase I trial to study the effectiveness of combining flavopiridol with radiation therapy followed by gemcitabine in treating patients who have locally advanced, unresectablepancreatic cancer.
Details: OBJECTIVES: - Determine the maximum tolerated dose of flavopiridol in combination with radiotherapy followed by gemcitabine in patients with locally advanced, unresectable pancreatic cancer. - Determine the toxicity of this regimen in these patients. - Determine the pharmacokinetics of flavopiridol in these patients. - Determine, preliminarily, the therapeutic activity of this regimen in these patients. OUTLINE: This is a dose-escalation study of flavopiridol. Patients receive flavopiridol IV over 1 hour twice weekly (on days 1 and 4 or days 2 and 5) for 6 weeks. Concurrently, patients undergo radiotherapy once daily 5 days a week for 5.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Four weeks after the completion of radiotherapy, patients are re-evaluated*. Beginning within 4-7 weeks after the completion of radiotherapy, patients receive gemcitabine IV over 30 minutes weekly for 3 weeks. Treatment repeats every 4 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. NOTE: *Patients whose imaging studies suggest potential curative resection are referred for a surgical evaluation before initiating gemcitabine therapy. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 10 additional patients are treated at the recommended phase II dose. Patients are followed at 4 weeks and then every 8 weeks thereafter. PROJECTED ACCRUAL: Approximately 3-46 patients will be accrued for this study within 2 years.
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 - No non-adenocarcinoma of the pancreas (i.e., islet cell, lymphoma, or sarcoma) - Locally advanced and unresectable disease defined as the following: - Obvious encasement of the celiac, hepatic, or superior mesenteric artery - Encasement of the portal or superior mesenteric vein not amenable to resection - Extrapancreatic extension with or without regional lymph node involvement - No distant metastases - Measurable or evaluable disease - Primary pancreatic tumor is considered evaluable, not measurable - A lymph node mass is considered measurable PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - More than 12 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 no greater than 1.5 mg/dL - AST and ALT no greater than 2.5 times upper limit of normal Renal - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance at least 60 mL/min Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Gastrointestinal - No Crohn's disease or inflammatory bowel disease that would preclude study participation - No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation Other - No other uncontrolled concurrent illness that would preclude study participation - No ongoing or active infection - No psychiatric illness or social situation that would preclude study participation - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy for this disease - No prior flavopiridol or other cyclin-dependent kinase therapies Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy for this disease Surgery - Prior curative surgery with local recurrence allowed Other - No other concurrent investigational therapy - No concurrent combination antiretroviral therapy for HIV-positive patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JeremyKortmansky, 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: CDR0000257662; MSKCC-02057,NCI-5764
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00047307
Other Stage 3 Pancreatic Cancer Studies:
1. Nitrocamptothecin Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer
2. Gemcitabine With or Without Capecitabine in Treating Patients With Advanced Pancreatic Cancer
3. UCN-01 and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer
4. Combination Chemotherapy in Treating Patients With Stage III or Stage IV Pancreatic Cancer That Cannot Be Removed by Surgery
5. Gemcitabine With or Without Cetuximab as First-Line Therapy in Treating Patients With Locally Advanced Unresectable or Metastatic Adenocarcinoma of the Pancreas
Related Studies:
Other stage 3 pancreatic cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Flavopiridol Plus Radiation Therapy Followed By Gemcitabine in Treating Patients With Locally Advanced, Unresectable Pancreatic Cancer
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