Phase II Study on TAXOL in Bronchioalveolar Carcinoma
18 Years
75 Years
Both
Lung Cancer
Trial Information
Phase II Study on TAXOL in Bronchioalveolar Carcinoma
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Giorgio Scagliotti, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Azienda Ospedale S. Luigi at University of Torino
Authority:
United States: Federal Government
Study ID:
EORTC-08956
NCT ID:
NCT00002972
Start Date:
January 1997
Completion Date:
Related Keywords:
- Lung Cancer
- recurrent non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- stage IV non-small cell lung cancer
- adenocarcinoma of the lung
- Adenocarcinoma, Bronchiolo-Alveolar
- Lung Neoplasms
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