Paclitaxel in Treating Patients With Lung Cancer

Lung Cancer Clinical Trial

Official title:

Phase II Study on TAXOL in Bronchioalveolar Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002972
• Other study ID #: EORTC-08956
• Secondary ID: EORTC-08956
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: June 29, 2012
• Start date: January 1997

Study information

• Verified date: June 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. primary completion date: August 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• paclitaxel

Locations

Country	Name	City	State
Belgium	Centre Hospitalier Regional de la Citadelle	Liege (Luik)
Czech Republic	University Thomayers' Hospital	Krhanice
Germany	Universitaetsklinik und Strahlenklinik - Essen	Essen
Italy	Azienda Ospedale S. Luigi - Universita Di Torino	Orbassano, (Torino)
Netherlands	Vrije Universiteit Medisch Centrum	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Belgium,  Czech Republic,  Germany,  Italy,  Netherlands, 

References & Publications (1)

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 s — View Citation