|
Erlotinib, Gemcitabine, and Radiation Therapy in Treating Patients With Locally Advanced Unresectable Pancreatic Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Erlotinib, Gemcitabine, and Radiation Therapy in Treating Patients With Locally Advanced Unresectable Pancreatic Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Erlotinib, Gemcitabine, and Radiation Therapy in Treating Patients With Locally Advanced Unresectable Pancreatic Cancer Clinical research trials and Erlotinib, Gemcitabine, and Radiation Therapy in Treating Patients With Locally Advanced Unresectable Pancreatic Cancer healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Erlotinib, Gemcitabine, and Radiation Therapy in Treating Patients With Locally Advanced Unresectable Pancreatic Cancer. Erlotinib, Gemcitabine, and Radiation Therapy in Treating Patients With Locally Advanced Unresectable Pancreatic Cancer Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Erlotinib, Gemcitabine, and Radiation Therapy in Treating Patients With Locally Advanced Unresectable Pancreatic Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their Erlotinib, Gemcitabine, and Radiation Therapy in Treating Patients With Locally Advanced Unresectable Pancreatic Cancer condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "E" Clinical Trials Conditions > Erlotinib, Gemcitabine, and Radiation Therapy in Treating Patients With Locally Advanced Unresectable Pancreatic Cancer  Erlotinib, Gemcitabine, and Radiation Therapy in Treating Patients With Locally Advanced Unresectable Pancreatic Cancer
Erlotinib, Gemcitabine, and Radiation Therapy in Treating Patients With Locally Advanced Unresectable Pancreatic Cancer
For Condition: recurrent pancreatic cancer,stage 2 pancreatic cancer,adenocarcinoma of the pancreas,stage 3 pancreatic cancer
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as gemcitabine, work in 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. Combining erlotinib with gemcitabine may make the tumor cells more sensitive to radiation therapy and may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining erlotinib with gemcitabine and radiation therapy in treating patients who have locally advancedunresectablepancreatic cancer.
Details: OBJECTIVES: - Determine the maximum tolerated dose of erlotinib given concurrently with gemcitabine and radiotherapy in patients with locally advanced unresectable pancreatic cancer. - Determine the toxicity of this regimen in these patients. - Determine, preliminarily, the antitumor efficacy of this regimen, in terms of response rate, in these patients. - Determine the time to tumor progression and overall survival of patients treated with this regimen. OUTLINE: This is a non-randomized, open-label, dose-escalation study of erlotinib. - Patients undergo radiotherapy 5 days a week for 5.5 weeks. Beginning on day 1 and continuing concurrently with radiotherapy, patients receive gemcitabine IV over 30 minutes twice weekly and oral erlotinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of erlotinib 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, an additional 10 patients receive treatment at that dose. Patients are radiologically restaged 3-4 weeks after completion of radiotherapy. Patients with stable or responsive disease proceed to maintenance therapy. Patients whose imaging studies suggest a potential for curative resection are referred for a surgical evaluation before initiating maintenance therapy. - Maintenance therapy: Beginning 4-7 weeks after the completion of chemoradiotherapy, patients receive maintenance chemotherapy comprising gemcitabine IV over 30 minutes on days 1 and 8 and oral erlotinib once daily. Treatment repeats every 21 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 19-28 patients will be accrued for this study.
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 - Locally advanced, unresectable disease, defined by all of the following: - Obvious encasement of the celiac, hepatic, or superior mesenteric artery - Encasement of the portal or superior mesenteric vein not amenable to surgical resection - Extrapancreatic extension with or without regional lymph node involvement - No evidence of distant metastatic disease by staging laparoscopy* NOTE: *Patients determined to be unsuitable for this procedure (e.g., prior abdominal surgery, adhesions, etc.) by a surgeon are allowed to participate provided all other eligibility criteria are met - Locally recurrent disease after prior curative surgery allowed provided the following are true: - No prior chemotherapy or radiotherapy - No evidence of distant metastatic disease by staging laparoscopy* NOTE: *Patients determined to be unsuitable for this procedure (e.g., prior abdominal surgery, adhesions, etc.) by a surgeon are allowed to participate provided all other eligibility criteria are met - No islet cell pancreatic cancer or lymphoma or sarcoma of the pancreas - Measurable or evaluable disease - Primary pancreatic tumor is considered evaluable and not measurable disease - Lymph node mass considered measurable disease - No known brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - More than 12 weeks Hematopoietic - WBC 3,000/mm^3 - Absolute neutrophil count 1,500/mm^3 - Platelet count 100,000/mm^3 Hepatic - Bilirubin 1.5 mg/dL - AST and ALT 2.5 times upper limit of normal Renal - Creatinine 2.0 mg/dL OR - Creatinine clearance 60 mL/min Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Ophthalmic - No abnormalities of the cornea based on history (e.g., dry eye syndrome or Sjögren's syndrome) - No congenital abnormality (e.g., Fuch's dystrophy) - No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose) - No abnormal corneal sensitivity test (Schirmer test or similar tear production test) Gastrointestinal - No Crohn's disease or inflammatory bowel disease that would preclude undergoing external beam radiotherapy - Able to tolerate oral medication - No requirement for IV alimentation Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No ongoing or active infection - No other concurrent uncontrolled illness - No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics - No prior gemcitabine Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics Surgery - See Disease Characteristics Other - No prior epidermal growth factor receptor-targeting therapy - No prior therapy for pancreatic cancer (except surgery) - No concurrent commercial or other investigational agents or therapies intended to treat the malignancy - 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, 10021-0009
United States
Recruiting Eileen O'Reilly 212-639-6672
Additional Information:
Study ID Numbers: CDR0000305855; NCI-5441,MSKCC-03031
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00063947
Other Adenocarcinoma Of The Pancreas Studies:
1. Two Chemotherapy Regimens Compared With Observation in Treating Patients With Completely Resected Pancreatic Cancer
2. Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
3. Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Unresectable Pancreatic Adenocarcinoma
4. UCN-01 and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer
5. Gene Therapy Combined With Chemotherapy and Radiation Therapy in Treating Patients With Pancreatic Cancer That Cannot Be Surgically Removed
Related Studies:
Other adenocarcinoma of the pancreas Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Erlotinib, Gemcitabine, and Radiation Therapy in Treating Patients With Locally Advanced Unresectable Pancreatic Cancer
|
|
|
|
|
|
|
|
