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Irinotecan With Docetaxel in Treating Patients With Recurrent or Metastatic Non-small Cell Lung Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Irinotecan With Docetaxel in Treating Patients With Recurrent or Metastatic Non-small Cell Lung Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Irinotecan With Docetaxel in Treating Patients With Recurrent or Metastatic Non-small Cell Lung Cancer Clinical research trials and Irinotecan With Docetaxel in Treating Patients With Recurrent or Metastatic Non-small Cell Lung Cancer healthcare trials happen in many 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 drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Irinotecan With Docetaxel in Treating Patients With Recurrent or Metastatic Non-small Cell Lung Cancer. Irinotecan With Docetaxel in Treating Patients With Recurrent or Metastatic Non-small Cell Lung Cancer Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Irinotecan With Docetaxel in Treating Patients With Recurrent or Metastatic Non-small Cell Lung Cancer clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Irinotecan With Docetaxel in Treating Patients With Recurrent or Metastatic Non-small Cell Lung Cancer condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > Irinotecan With Docetaxel in Treating Patients With Recurrent or Metastatic Non-small Cell Lung Cancer  Irinotecan With Docetaxel in Treating Patients With Recurrent or Metastatic Non-small Cell Lung Cancer
Irinotecan With Docetaxel in Treating Patients With Recurrent or Metastatic Non-small Cell Lung Cancer
For Condition: stage 4 non-small cell lung cancer,recurrent non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , North Central Cancer Treatment Group
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining irinotecan and docetaxel in treating patients who have recurrent or metastatic non-small cell lung cancer.
Details: OBJECTIVES: I. Evaluate the response rate of previously treated patients with recurrent non-small cell lung cancer after treatment with irinotecan and docetaxel. II. Determine the toxicity of this regimen in these patients. III. Determine the overall survival in this patient population. PROTOCOL OUTLINE: Patients receive irinotecan IV over 90 minutes immediately followed by docetaxel IV over 60 minutes on day 1. Treatment is repeated every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 5 years or until death. PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study within 24 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed non-small cell lung cancer (NSCLC); Reconfirmation of NSCLC required only if complete response for greater than 1 year - Measurable or evaluable disease - Tumor shrinkage or stability for at least 4 weeks on initial chemotherapy - CNS metastases allowed, if symptoms controlled for greater than 8 weeks after surgery or radiotherapy --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: See Disease Characteristics; No greater than 1 prior NSCLC chemotherapy regimen, excluding low dose cisplatin as a radiosensitizer; No prior irinotecan or docetaxel; At least 4 weeks since prior chemotherapy - Endocrine therapy: Not specified - Radiotherapy: See Disease Characteristics; At least 4 weeks since prior radiotherapy No prior radiotherapy to greater than 25% of bone marrow - Surgery: See Disease Characteristics - Other: No concurrent phenytoin, phenobarbital, or other anticonvulsants --Patient Characteristics-- - Age: 18 and over - Performance status: 0-1 - Life expectancy: At least 12 weeks - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin normal; AST no greater than 2 times upper limit of normal (ULN) - Renal: Creatinine no greater than 2.5 times ULN - Cardiovascular: No New York Heart Association class III or IV heart disease - Other: No active infection; At least 5 years since any other prior malignancy except curatively treated basal or squamous cell skin cancer, carcinoma in situ, or other cancers; No grade 2 or worse peripheral neuropathy; No uncontrolled diabetes mellitus; No other serious underlying disease; Not pregnant or nursing; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AlexAdjei, Study Chair, North Central Cancer Treatment Group
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57105-1080
United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
United States
Saskatchewan Cancer Agency
Regina, Saskatchewan, S4S 6X3
Canada
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68131
United States
CentraCare Clinic
St. Cloud, Minnesota, 56303
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
Quain & Ramstad Clinic, P.C.
Bismark, North Dakota, 58501
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
Altru Health Systems
Grand Forks, North Dakota, 58201
United States
Additional Information:
Study ID Numbers: CDR0000067071; NCCTG-982453
Study Start Date: October 1999
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003900
Other Recurrent Non-Small Cell Lung Cancer Studies:
1. Carboplatin and Paclitaxel in Treating Older Patients With Metastatic or Recurrent Unresectable Non-small Cell Lung Cancer
2. Antineoplaston Therapy in Treating Patients With Recurrent or Stage IV Lung Cancer
3. Combination Chemotherapy in Treating Patients With Advanced Non-Small Cell Lung Cancer
4. Paclitaxel in Treating Patients With Lung Cancer
5. R115777 in Treating Patients With Recurrent or Metastatic Non-small Cell Lung Cancer
Related Studies:
Other recurrent non-small cell lung cancer Clinical Trials
Other Minnesota Clinical Trials
Other Duluth Clinical Trials
Irinotecan With Docetaxel in Treating Patients With Recurrent or Metastatic Non-small Cell Lung Cancer
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