Overview

Paclitaxel in Treating Patients With Extensive-Stage Small Cell Lung Cancer

Status:
Completed
Trial end date:
2008-02-01
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 extensive-stage small cell lung cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborator:
National Cancer Institute (NCI)
Treatments:
Albumin-Bound Paclitaxel
Paclitaxel
Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed extensive stage small
cell carcinoma of the bronchus Extrathoracic metastatic disease, malignant pleural
effusion, bilateral or contralateral supraclavicular adenopathy or contralateral hilar
adenopathy Measurable disease One lesion that measures at least 20 mm in diameter using
conventional techniques or at least 10 mm with spiral CT scan Lesions not considered
measurable include: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial
effusion Cystic lesions Tumor lesions situated in a previously irradiated area Abdominal
masses not confirmed and followed by imaging techniques No disease restricted to one
hemithorax with regional lymph node metastases, including hilar, ipsilateral and
contralateral mediastinal, and/or ipsilateral supraclavicular nodes

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: CTC 0-2 Life expectancy: Not
specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least
100,000/mm3 Hepatic: SGOT less than 2 times upper limit of normal Bilirubin less than 1.5
mg/dL Renal: Not specified Other: Not pregnant or nursing Fertile patients must use
effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: No concurrent hormonal therapy except steroids for renal
failure or hormones administered for nondisease related conditions Radiotherapy: At least
two weeks since prior radiotherapy No concurrent palliative radiotherapy Surgery: Not
specified