Paclitaxel and Irinotecan in Treating Patients With Advanced Non-small Cell Lung Cancer

• Status: Completed
• Trial end date: 2006-02-01
• 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. Combining more than one drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving paclitaxel together with irinotecan works in treating patients with advanced non-small cell lung cancer.

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

Details

• Lead Sponsor: Yale University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Camptothecin; Irinotecan; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed metastatic non-small cell lung cancer for which no curative therapy exists

• Stage IIIB with pleural effusion allowed

• Measurable or evaluable disease

• CNS metastases allowed if disease stable at least 4 weeks following completion of surgery and/or radiotherapy and no anticonvulsant required

PATIENT CHARACTERISTICS:

Age:

• Over 18

Performance status:

• ECOG 0-2

Life expectancy:

• At least 3 months

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count greater than 100,000/mm^3

Hepatic:

• Bilirubin less than 2.0 mg/dL

• SGOT no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN if tumor involves liver)

Renal:

• Creatinine clearance at least 70 mL/min

Other:

• No other malignancies within past 3 years except nonmelanomatous skin cancer and carcinoma in situ of the cervix

• HIV negative

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective birth control

• No active infection

• No concurrent medical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior systemic chemotherapy for lung cancer

• No prior irinotecan or paclitaxel

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

• At least 4 weeks since prior wide field radiotherapy

• No prior radiotherapy to greater than 20% of bone marrow allowed

Surgery:

• See Disease Characteristics

• Recovered from prior surgery