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Sponsored by: |
European Organization for Research and Treatment of Cancer |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002972 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have unresectable stage IIIB, stage IV or recurrent lung cancer.
Condition | Intervention | Phase |
Lung Cancer |
Drug: paclitaxel |
Phase II |
MedlinePlus related topics: | Cancer Lung Cancer |
ChemIDplus related topics: | Paclitaxel |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control |
Official Title: | Phase II Study on TAXOL in Bronchioalveolar Carcinoma |
Estimated Enrollment: | 25 |
Study Start Date: | January 1997 |
OBJECTIVES:
OUTLINE: This is an open label, nonrandomized, multicenter study.
Paclitaxel is administered every 3 weeks as a 3 hour continuous infusion in dextrose or normal saline. Patients are treated for a minimum of 2 cycles unless serious toxicity or complication occur.
Disease is assessed every 6 weeks until documented progression; treatment side effects are assessed separately for each cycle of therapy. Treatment is given up to a maximum of 6 cycles of therapy or until disease progression, unacceptable toxicity, or patient refusal occurs.
PROJECTED ACCRUAL: 16 or 25 patients will be accrued.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven bronchoalveolar carcinoma (BAC) based on these criteria:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Belgium | |||||
Centre Hospitalier Regional de la Citadelle | |||||
Liege (Luik), Belgium, 4000 | |||||
Czech Republic | |||||
University Thomayers' Hospital | |||||
Krhanice, Czech Republic, 257 42 | |||||
Germany | |||||
Universitaetsklinik und Strahlenklinik - Essen | |||||
Essen, Germany, D-45122 | |||||
Italy | |||||
Azienda Ospedale S. Luigi - Universita Di Torino | |||||
Orbassano, (Torino), Italy, 10043 | |||||
Netherlands | |||||
Vrije Universiteit Medisch Centrum | |||||
Amsterdam, Netherlands, 1001HV |
European Organization for Research and Treatment of Cancer |
Study Chair: | Giorgio Scagliotti, MD, PhD | Azienda Ospedale S. Luigi at University of Torino |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000065481, EORTC-08956 |
First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00002972 |
Health Authority: | United States: Federal Government |
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