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| Sponsor: | European Organization for Research and Treatment of Cancer |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002972 |
Purpose
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 |
| 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.
Eligibility| 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:
Contacts and Locations| 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 | |
| Study Chair: | Giorgio Scagliotti, MD, PhD | Azienda Ospedale S. Luigi at University of Torino |
More Information
| Study ID Numbers: | CDR0000065481, EORTC-08956 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00002972 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer adenocarcinoma of the lung |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Antimitotic Agents Pharmacologic Actions Neoplasms |
Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Paclitaxel Therapeutic Uses Lung Diseases Tubulin Modulators Antineoplastic Agents, Phytogenic |