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| Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00022646 |
Purpose
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.
| Condition | Intervention | Phase |
|
Lung Cancer |
Drug: gemcitabine hydrochloride Drug: pemetrexed disodium |
Phase II |
| MedlinePlus related topics: | Cancer Lung Cancer |
| ChemIDplus related topics: | Gemcitabine hydrochloride Gemcitabine Pemetrexed disodium Pemetrexed |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control |
| Official Title: | A Phase II Clinical Trial Evaluating Three Schedules Of ALIMTA Plus Gemcitabine As Frontline Chemotherapy For Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer |
| Study Start Date: | August 2001 |
OBJECTIVES:
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.
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
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Arizona | |||||
| CCOP - Scottsdale Oncology Program | |||||
| Scottsdale, Arizona, United States, 85259-5404 | |||||
| United States, Florida | |||||
| Mayo Clinic | |||||
| Jacksonville, Florida, United States, 32224 | |||||
| United States, Illinois | |||||
| CCOP - Carle Cancer Center | |||||
| Urbana, Illinois, United States, 61801 | |||||
| CCOP - Illinois Oncology Research Association | |||||
| Peoria, Illinois, United States, 61602 | |||||
| United States, Iowa | |||||
| CCOP - Cedar Rapids Oncology Project | |||||
| Cedar Rapids, Iowa, United States, 52403-1206 | |||||
| CCOP - Iowa Oncology Research Association | |||||
| Des Moines, Iowa, United States, 50309-1016 | |||||
| Siouxland Hematology-Oncology | |||||
| Sioux City, Iowa, United States, 51101-1733 | |||||
| United States, Kansas | |||||
| CCOP - Wichita | |||||
| Wichita, Kansas, United States, 67214-3882 | |||||
| United States, Michigan | |||||
| CCOP - Ann Arbor Regional | |||||
| Ann Arbor, Michigan, United States, 48106 | |||||
| United States, Minnesota | |||||
| CCOP - Duluth | |||||
| Duluth, Minnesota, United States, 55805 | |||||
| CCOP - Metro-Minnesota | |||||
| Saint Louis Park, Minnesota, United States, 55416 | |||||
| CentraCare Health Plaza | |||||
| Saint Cloud, Minnesota, United States, 56303 | |||||
| Mayo Clinic Cancer Center | |||||
| Rochester, Minnesota, United States, 55905 | |||||
| United States, Nebraska | |||||
| CCOP - Missouri Valley Cancer Consortium | |||||
| Omaha, Nebraska, United States, 68106 | |||||
| United States, North Dakota | |||||
| Altru Health Systems | |||||
| Grand Forks, North Dakota, United States, 58201 | |||||
| CCOP - Merit Care Hospital | |||||
| Fargo, North Dakota, United States, 58122 | |||||
| Medcenter One Health System | |||||
| Bismarck, North Dakota, United States, 58501 | |||||
| United States, Ohio | |||||
| CCOP - Toledo Community Hospital | |||||
| Toledo, Ohio, United States, 43623-3456 | |||||
| United States, Pennsylvania | |||||
| Allegheny General Hospital | |||||
| Pittsburgh, Pennsylvania, United States, 15212-4772 | |||||
| CCOP - Geisinger Clinic and Medical Center | |||||
| Danville, Pennsylvania, United States, 17822-2001 | |||||
| United States, South Dakota | |||||
| CCOP - Sioux Community Cancer Consortium | |||||
| Sioux Falls, South Dakota, United States, 57104 | |||||
| Rapid City Regional Hospital | |||||
| Rapid City, South Dakota, United States, 57709 | |||||
| North Central Cancer Treatment Group |
| National Cancer Institute (NCI) |
| Study Chair: | Alex A. Adjei, MD, PhD | Mayo Clinic |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
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Campbell ME, Mandrekar SJ, Hillman SL, et al.: What is the added value of actual tumor measurements (TM) in predicting overall survival (OS)? The North Central Cancer Treatment Group (NCCTG) findings. [Abstract] J Clin Oncol 26 (Suppl 15): A-6520, 2008.
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Jatoi A, Hillman S, Stella P, Green E, Adjei A, Nair S, Perez E, Amin B, Schild SE, Castillo R, Jett JR; North Central Cancer Treatment Group. Should elderly non-small-cell lung cancer patients be offered elderly-specific trials? Results of a pooled analysis from the North Central Cancer Treatment Group. J Clin Oncol. 2005 Dec 20;23(36):9113-9.
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| Study ID Numbers: | CDR0000068838, NCCTG-N0026 |
| First Received: | August 10, 2001 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00022646 |
| Health Authority: | United States: Federal Government |
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