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Home > "P" Clinical Trials Conditions > Paclitaxel in Treating Patients With Lung Cancer  Paclitaxel in Treating Patients With Lung Cancer
Paclitaxel in Treating Patients With Lung Cancer
For Condition: stage 3B non-small cell lung cancer,recurrent non-small cell lung cancer,adenocarcinoma of the lung,stage 4 non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): EORTC Lung Cancer Cooperative Group ,
Synopsis: 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.
Details: OBJECTIVES: I. Assess the therapeutic activity of paclitaxel in patients with bronchoalveolar carcinoma (BAC). II. Assess the duration of response in patients presenting with an objective response. III. Characterize the acute side effects of paclitaxel in patients with BAC. IV. Assess the role of some biological parameters in the natural history and the response to therapy of BAC; evaluate the expression of Ki67, p53, and K-ras mutation. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/75 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically proven bronchoalveolar carcinoma (BAC) based on these criteria: - absence of primary adenocarcinoma elsewhere - absence of a demonstrable central bronchogenic origin - a peripheral location in the lung parenchyma - intact interstitial framework of the lung - a histological appearance setting it apart from other tumors, with a characteristic pattern of growth: cuboidal or cylindrical cells lining up the alveolar septa with preservation of basic pulmonary architecture Must be unresectable Stage IIIB, IV, or recurrent BAC Evidence of multinodular lesions involving the lungs bilaterally or unilaterally (in the latter the lesions must involve more than one lobe) At least one target lesion bidimensionally measurable that has not undergone prior irradiation No CNS disease --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: - At least 4 weeks since radiotherapy - Must have at least one bidimensional lesion outside the irradiated fields Surgery: Fully recovered from any prior major surgery --Patient Characteristics-- Age: 18 to 75 (inclusive) Performance status: ECOG 0-2 Life expectancy: Greater than 3 months Hematopoietic: ANC at least 1,500/mm3 Hepatic: - Bilirubin less than 2 times upper limit of normal - SGOT, SGPT, and alkaline phosphatase less than 2 times upper limit of normal Renal: Creatinine less than 1.5 times upper limit of normal Cardiovascular: - No history of ischemic or congestive heart disease - No arrhythmia requiring chronic cardiopulmonary medications - No history of clinically or electrographically documented myocardial infarction Other: - No preexisting motor or other serious sensory neurotoxicity - No active or prior second primary cancer except basal cell carcinoma of the skin or carcinoma in situ of the cervix - No clinical evidence of uncontrolled infection - Not pregnant or nursing - Negative pregnancy test 72 hours prior to start of study medication - Adequate contraception required of all fertile patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GiorgioScagliotti, Study Chair, EORTC Lung Cancer Cooperative Group
University Thomayers' Hospital
Krhanice, , 257 42
Czech Republic
Vrije Universiteit Medisch Centrum
Amsterdam, , 1001HV
Netherlands
Centre Hospitalier Regional de la Citadelle
Liege (Luik), , 4000
Belgium
Universitaetsklinik und Strahlenklinik - Essen
ESSEN, , D-45122
Germany
Azienda Ospedale S. Luigi - Universita Di Torino
Orbassano, (Torino), , 10043
Italy
Additional Information:
Study ID Numbers: CDR0000065481; EORTC-08956
Study Start Date: January 1997
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002972
Other Stage 3b Non-Small Cell Lung Cancer Studies:
1. Combination Chemotherapy With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
2. Prognostic Study of Metastases in Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer That Can Be Removed by Surgery
3. Paclitaxel With or Without Carboplatin in Treating Patients With Advanced Non-small Cell Lung Cancer
4. Combination Chemotherapy Plus Radiation Therapy With or Without AE-941 in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery
5. Erlotinib and Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer
Related Studies:
Other stage 3B non-small cell lung cancer Clinical Trials
Other Clinical Trials
Other Krhanice Clinical Trials
Paclitaxel in Treating Patients With Lung Cancer
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