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

NCT ID: NCT00004924

Last Updated: 2009-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-03-31
• Study Completion Date: 2006-02-28

Brief 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.

Detailed Description

OBJECTIVES:

• Determine the antitumor activity and toxicities of irinotecan and paclitaxel in patients with advanced non-small cell lung cancer.

OUTLINE: Patients receive paclitaxel IV over 1 hour followed immediately by irinotecan IV over 30 minutes. Treatment continues weekly for 2 weeks followed by one week of rest. Courses are repeated every 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year, then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 11-22 patients will be accrued for this study over 12 months.

Conditions

Lung Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

irinotecan hydrochloride

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Principal Investigators

John R. Murren, MD

Role: STUDY_CHAIR

Yale University

Locations

Yale Comprehensive Cancer Center

New Haven, Connecticut, United States

Northwestern Connecticut Oncology-Hematology Associates - Torrington

Torrington, Connecticut, United States

Countries

United States

Other Identifiers

YALE-HIC-10740

Identifier Type: -

Identifier Source: secondary_id

NCI-G00-1701

Identifier Type: -

Identifier Source: secondary_id

CDR0000067608

Identifier Type: -

Identifier Source: org_study_id