Paclitaxel in Treating Patients With Lung Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

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