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Pemetrexed Disodium Plus Gemcitabine in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Pemetrexed Disodium Plus Gemcitabine in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Pemetrexed Disodium Plus Gemcitabine in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Clinical research trials and Pemetrexed Disodium Plus Gemcitabine in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Pemetrexed Disodium Plus Gemcitabine in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer. Pemetrexed Disodium Plus Gemcitabine in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Pemetrexed Disodium Plus Gemcitabine in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer clinical trial. Human subjects often get the best healthcare possible for their Pemetrexed Disodium Plus Gemcitabine in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Pemetrexed Disodium Plus Gemcitabine in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer  Pemetrexed Disodium Plus Gemcitabine in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Pemetrexed Disodium Plus Gemcitabine in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
For Condition: stage 3B non-small cell lung cancer,stage 4 non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): North Central Cancer Treatment Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug and giving the drugs in different ways may kill more tumor cells. PURPOSE: Randomized phase II trial to compare the effectiveness of three different regimens of pemetrexed disodium plus gemcitabine in treating patients who have locally advanced or metastatic non-small cell lung cancer.
Details: OBJECTIVES: - Compare the tumor response rates in patients with locally advanced or metastatic non-small cell lung cancer treated with 3 different schedules of pemetrexed disodium and gemcitabine. - Compare the duration of response, time to progressive disease, time to treatment failure, and survival time in patients treated with these regimens. - Compare the quantitative and qualitative toxic effects of these regimens in these patients. OUTLINE: This is a randomized, open-label study. Patients are stratified according to stage of disease (IIIB vs IV) and ECOG performance status (0 vs 1). Patients are randomized to one of three treatment arms. - Arm I: Patients receive pemetrexed disodium IV over 10 minutes on day 1 followed by gemcitabine IV over 30 minutes on days 1 and 8. - Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by pemetrexed disodium IV over 10 minutes on day 1. - Arm III: Patients receive gemcitabine IV over 30 minutes on day 1 and pemetrexed disodium IV over 10 minutes followed by gemcitabine IV over 30 minutes on day 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive up to 6 additional courses of therapy. Patients are followed every 2 months for 1 year and then every 6 months for 4 years. PROJECTED ACCRUAL: A total of 180 patients (60 per treatment arm) will be accrued for this study within 20 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 non-small cell lung cancer - Stage IIIB disease that is ineligible for combined modality therapy OR - Stage IV disease - Measurable disease - No clinically detectable (by physical exam) third-space fluid collection (e.g., ascites or pleural effusions) that cannot be controlled by drainage or other procedures - No brain metastases (even if treated) PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 Life expectancy: - At least 12 weeks Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9 g/dL Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST and ALT no greater than 3 times ULN (5 times ULN if liver metastases present) - Alkaline phosphatase no greater than 3 times ULN (5 times ULN if liver metastases present) Renal: - Creatinine clearance at least 45 mL/min Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Able to take folic acid or cyanocobalamin (vitamin B12) supplementation - No uncontrolled infection - No concurrent chronic debilitating disease - No weight loss of 10% or more within the past 6 weeks - No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinoma PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior biologic or genetic therapy for lung cancer - No concurrent immunomodulating agents Chemotherapy: - No prior chemotherapy for lung cancer Endocrine therapy: - Not specified Radiotherapy: - At least 4 weeks since prior radiotherapy to a different site and recovered - No prior radiotherapy to 25% or more of bone marrow - No prior radiotherapy to whole pelvis - No prior radiotherapy for primary disease - No concurrent radiotherapy Surgery: - More than 4 weeks since prior major surgery Other: - No aspirin or nonsteroidal anti-inflammatory agents 2 days before, during, and for 2 days after pemetrexed disodium administration (5 days for long-acting agents such as piroxicam, naproxen, diflunisal, or nabumetone) - No other concurrent cytostatic or cytotoxic therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AlexAdjei, Study Chair, Mayo Clinic Cancer Center
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
CentraCare Health Plaza
St. Cloud, Minnesota, 56303
United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
United States
Altru Health Systems
Grand Forks, North Dakota, 58201
United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212-4772
United States
Medcenter One Health System
Bismark, North Dakota, 58501
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
United States
CCOP - Toledo Community Hospital
Toledo, Ohio, 43623-3456
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
Additional Information:
Study ID Numbers: CDR0000068838; NCCTG-N0026
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00022646
Other Stage 4 Non-Small Cell Lung Cancer Studies:
1. Paclitaxel With or Without Carboplatin in Treating Patients With Advanced Non-small Cell Lung Cancer
2. Paclitaxel and Irinotecan in Treating Patients With Advanced Non-small Cell Lung Cancer
3. Paclitaxel and Oxaliplatin in Treating Patients With Recurrent or Advanced Non-small Cell Lung Cancer
4. Irinotecan and Whole-Brain Radiation Therapy in Treating Patients With Unresectable Brain Metastases From Non-Small Cell Lung Cancer
5. Carboplatin and Paclitaxel in Treating Older Patients With Metastatic or Recurrent Unresectable Non-small Cell Lung Cancer
Related Studies:
Other stage 4 non-small cell lung cancer Clinical Trials
Other Minnesota Clinical Trials
Other St. Cloud Clinical Trials
Pemetrexed Disodium Plus Gemcitabine in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
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