Paclitaxel in Treating Patients With Lung Cancer

NCT ID: NCT00002972

Last Updated: 2012-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-01-31

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

paclitaxel

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giorgio Scagliotti, MD, PhD

Role: STUDY_CHAIR

Azienda Ospedale S. Luigi at University of Torino

Locations

University Thomayers' Hospital

Krhanice, , Czechia

Universitaetsklinik und Strahlenklinik - Essen

Essen, , Germany

Azienda Ospedale S. Luigi - Universita Di Torino

Orbassano, (Torino), , Italy

Vrije Universiteit Medisch Centrum

Amsterdam, , Netherlands

Centre Hospitalier Regional de la Citadelle

Liege (Luik), , Belgium

Countries

Belgium; Czechia; Germany; Italy; Netherlands

References

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.

Reference Type: RESULT

PMID: 16019107 (View on PubMed)

Other Identifiers

EORTC-08956

Identifier Type: -

Identifier Source: secondary_id

EORTC-08956

Identifier Type: -

Identifier Source: org_study_id