Phase II Study on TAXOL in Bronchioalveolar Carcinoma
paclitaxel
Adenocarcinoma+12
+ Bronchial Neoplasms
+ Carcinoma
Treatment Study
Summary
Study start date: January 1, 1997
Actual date on which the first participant was enrolled.OBJECTIVES: Assess the therapeutic activity of paclitaxel in patients with bronchoalveolar carcinoma (BAC). Assess the duration of response in patients presenting with an objective response. Characterize the acute side effects of paclitaxel in patients with BAC. 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. 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.25 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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 PATIENT CHARACTERISTICS: Age: 18 to 75 (inclusive) Performance status: ECOG 0-2 Life expectancy: Greater than 3 months Hematopoietic: ANC at least 1,500/mm^3 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 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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 5 locations
Centre Hospitalier Regional de la Citadelle
Liege (Luik), BelgiumOpen Centre Hospitalier Regional de la Citadelle in Google MapsUniversity Thomayers' Hospital
Krhanice, CzechiaUniversitaetsklinik und Strahlenklinik - Essen
Essen, GermanyAzienda Ospedale S. Luigi - Universita Di Torino
Orbassano, (Torino), Italy