Clinical trial NCT00002972: Paclitaxel in Treating Patients With Lung Cancer
Official title: Phase II Study on TAXOL in Bronchioalveolar Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
adenocarcinoma of the lung
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
First posted: 2003-04-17
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Liege (Luik)
country: Belgium
facility: Centre Hospitalier Regional de la Citadelle
city: Krhanice
country: Czech Republic
facility: University Thomayers' Hospital
city: Essen
country: Germany
facility: Universitaetsklinik und Strahlenklinik - Essen
city: Orbassano, (Torino)
country: Italy
facility: Azienda Ospedale S. Luigi - Universita Di Torino
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Medisch Centrum
Study officials:
affiliation: Azienda Ospedale S. Luigi at University of Torino
name: Giorgio Scagliotti, MD, PhD
role: STUDY_CHAIR
References:
citation: Scagliotti GV, Smit E, Bosquee L, O'Brien M, Ardizzoni A, Zatloukal P, Eberhardt W, Smid-Geirnaerdt M, de Bruin HG, Dussenne S, Legrand C, Giaccone G; European Organisation for Research and Treatment of Cancer (EORTC) Lung Cancer Group (LCG). A phase II study of paclitaxel in advanced bronchioloalveolar carcinoma (EORTC trial 08956). Lung Cancer. 2005 Oct;50(1):91-6. doi: 10.1016/j.lungcan.2005.05.012.