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Erlotinib Combined With Gemcitabine in Treating Patients With Newly Diagnosed Locally Advanced or Metastatic Pancreatic Cancer or Other Solid Tumors Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Erlotinib Combined With Gemcitabine in Treating Patients With Newly Diagnosed Locally Advanced or Metastatic Pancreatic Cancer or Other Solid Tumors conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Erlotinib Combined With Gemcitabine in Treating Patients With Newly Diagnosed Locally Advanced or Metastatic Pancreatic Cancer or Other Solid Tumors Clinical research trials and Erlotinib Combined With Gemcitabine in Treating Patients With Newly Diagnosed Locally Advanced or Metastatic Pancreatic Cancer or Other Solid Tumors health trials occur in hundreds of cities 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 assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Erlotinib Combined With Gemcitabine in Treating Patients With Newly Diagnosed Locally Advanced or Metastatic Pancreatic Cancer or Other Solid Tumors. Erlotinib Combined With Gemcitabine in Treating Patients With Newly Diagnosed Locally Advanced or Metastatic Pancreatic Cancer or Other Solid Tumors Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Erlotinib Combined With Gemcitabine in Treating Patients With Newly Diagnosed Locally Advanced or Metastatic Pancreatic Cancer or Other Solid Tumors clinical trial. Participants oftentimes recieve the most expert healthcare available for their Erlotinib Combined With Gemcitabine in Treating Patients With Newly Diagnosed Locally Advanced or Metastatic Pancreatic Cancer or Other Solid Tumors condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Erlotinib Combined With Gemcitabine in Treating Patients With Newly Diagnosed Locally Advanced or Metastatic Pancreatic Cancer or Other Solid Tumors  Erlotinib Combined With Gemcitabine in Treating Patients With Newly Diagnosed Locally Advanced or Metastatic Pancreatic Cancer or Other Solid Tumors
Erlotinib Combined With Gemcitabine in Treating Patients With Newly Diagnosed Locally Advanced or Metastatic Pancreatic Cancer or Other Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific,stage 4B pancreatic cancer,stage 4A pancreatic cancer,stage 3 pancreatic cancer,recurrent pancreatic cancer,stage 2 pancreatic cancer
Status: Completed
Sponsor(s): OSI Pharmaceuticals ,
Synopsis: RATIONALE: Erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib with gemcitabine may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining erlotinib with gemcitabine in treating patients who have newly diagnosed locally advanced or metastatic pancreatic cancer or other solid tumors.
Details: OBJECTIVES: - Determine the maximum tolerated dose of erlotinib in combination with gemcitabine in patients with recently diagnosed, gemcitabine-naive, locally advanced or metastatic pancreatic carcinoma or other potentially responsive solid tumor. - Determine the safety and tolerability of this regimen in these patients. - Determine the pharmacokinetics of this regimen in these patients. - Determine the objective antitumor response rate and response duration in patients treated with this regimen. - Determine the time to disease progression and duration of overall survival in patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of erlotinib. Patients receive gemcitabine IV over 30 minutes on day 1 of weeks 1-7 and oral erlotinib once daily beginning on day 3 of week 1 and continuing for 8 weeks (course 1). Patients receive subsequent courses of therapy comprising gemcitabine once weekly for 3 weeks and erlotinib once daily. Courses repeat every 4 weeks 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, 12 additional patients are accrued and treated at the MTD as above. Patients are followed at 30 days. PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study within 3 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed locally advanced or metastatic epithelial carcinoma of the pancreas or other malignancy considered to be potentially responsive to gemcitabine - Newly diagnosed or gemcitabine naive - Measurable or evaluable disease - Not amenable to surgical intervention due to medical contraindications or non-resectability of the tumor - No islet cell tumors or other non-epithelial cell carcinomas of the pancreas - No active CNS metastases or leptomeningeal disease - Treated or asymptomatic brain metastases are allowed if on a stable dose of corticosteroids and/or there is no change in brain disease status for at least 4 weeks after related therapy (e.g., whole-brain radiotherapy) PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 70-100% Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 2.0 mg/dL (except for documented Gilbert's syndrome) - AST or ALT less than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if hepatic obstruction or metastases present) - Albumin at least 2.5 g/dL Renal: - Creatinine less than 1.5 times ULN OR - Creatinine clearance at least 60 mL/min Cardiovascular: - No significant cardiovascular disease - No history of congestive heart failure currently requiring therapy - No ventricular arrhythmia requiring anti-arrhythmic therapy - No severe conduction disturbances - No angina pectoris requiring therapy - No myocardial infarction within the past 6 months Gastrointestinal: - No significant gastrointestinal abnormalities including: - Requirement for IV alimentation - Active peptic ulcer disease Ophthalmic: - No significant ophthalmologic abnormalities including: - Severe dry eye syndrome - Keratoconjunctivitis sicca - Sjogren's syndrome - Severe exposure keratopathy - Disorders that would increase the risk for epithelium-related complications (e.g., bullous keratopathy, aniridia, severe chemical burns, or neutrophilic keratitis) - Abnormal Schirmer test (less than 2 mm) allowed provided there is no evidence of clinically significant corneal surface abnormalities Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No known or suspected hypersensitivity to gemcitabine - No uncontrolled infection - HIV negative - No other malignancy within the past 5 years except treated non-melanoma skin cancer or carcinoma in situ of the breast or cervix - No other life-threatening illness - No psychiatric disorders or altered mental status the would preclude informed consent or study PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 28 days since prior immunotherapy or biological response modified therapy for the primary malignancy - No concurrent immunotherapy or biologic response modifier therapy for the primary malignancy Chemotherapy: - See Disease Characteristics - At least 28 days since prior chemotherapy for the primary malignancy - No prior mitomycin or nitrosoureas for the primary malignancy - No more than 6 prior courses of chemotherapy with an alkylating agent for the primary malignancy - No prior gemcitabine for the primary malignancy except as a low-dose (less than 500 mg/m^2) radiosensitizer administered concurrently with or within 2 weeks after radiotherapy at least 3 months ago - No other concurrent chemotherapy for the primary malignancy Endocrine therapy: - See Disease Characteristics - At least 28 days since prior systemic hormonal therapy (except LH-RH agonists) for the primary malignancy - No concurrent systemic hormonal therapy (except LH-RH agonists) for the primary malignancy - Other concurrent endocrine therapy is allowed as follows: - Hormonal therapy (e.g., megestrol) for appetite stimulation - Nasal, ophthalmic, or topical glucocorticoids - Oral glucocorticoids for adrenal insufficiency - Low-dose maintenance steroids Radiotherapy: - See Disease Characteristics - At least 28 days since prior radiotherapy for the primary malignancy or metastases and recovered - No prior wide-field radiotherapy to 25% or more of marrow-bearing bone - No prior pelvic irradiation - No concurrent radiotherapy for the primary malignancy or metastases - No concurrent wide-field radiotherapy for pain management Surgery: - See Disease Characteristics - Recovered from any prior surgery - No prior surgical procedures affecting absorption Other: - No prior agent for the primary malignancy targeting the epidermal growth factor receptor (EGFR) or EGFR-specific tyrosine kinase activity
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PedroSantabarbara, Study Chair, OSI Pharmaceuticals
Cancer Therapy and Research Center
San Antonio, Texas, 78229-3271
United States
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, 85724
United States
Additional Information:
Study ID Numbers: CDR0000069266; NCI-V02-1694,OSI-774-155,UARIZ-HSC-01128
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00033241
Other Stage 3 Pancreatic Cancer Studies:
1. Fenretinide in Treating Patients With Solid Tumors
2. Interleukin-12 Plus Interleukin-2 in Treating Patients With Advanced Solid Tumors
3. Chemotherapy and Amifostine in Treating Patients With Recurrent or Refractory Solid Tumors
4. Chemotherapy in Treating Patients With Advanced Solid Tumors
5. Ginger in Treating Nausea in Patients Receiving Chemotherapy for Cancer
Related Studies:
Other stage 3 pancreatic cancer Clinical Trials
Other Texas Clinical Trials
Other San Antonio Clinical Trials
Erlotinib Combined With Gemcitabine in Treating Patients With Newly Diagnosed Locally Advanced or Metastatic Pancreatic Cancer or Other Solid Tumors
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