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Clinical Trials/NCT00002972
NCT00002972CompletedPhase 2

Phase II Study on TAXOL in Bronchioalveolar Carcinoma

European Organisation for Research and Treatment of Cancer - EORTC10 sites in 6 countries25 target enrollmentStarted: January 1, 1997Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
25
Locations
10
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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:
  • •18 to 75 (inclusive)
  • •Performance status:
  • •Life expectancy:
  • •Greater than 3 months
  • •Hematopoietic:
  • •ANC at least 1,500/mm^3
  • •Bilirubin less than 2 times upper limit of normal
  • •SGOT, SGPT, and alkaline phosphatase less than 2 times upper limit of normal
  • •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
  • •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
  • •Fully recovered from any prior major surgery

Exclusion Criteria

  • Not provided

Investigators

Sponsor Class
Network
Responsible Party
Sponsor

Study Sites (10)

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