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

Lung Cancer Clinical Trial

Official title:

Phase II Trial of Irinotecan Plus Paclitaxel in Patients With Advanced Nonsmall Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004924
• Other study ID #: CDR0000067608
• Secondary ID: YALE-HIC-10740NC
• Status: Completed
• Phase: Phase 2
• First received: March 7, 2000
• Last updated: August 21, 2009
• Start date: March 1999
• Est. completion date: February 2006

Study information

• Verified date: August 2009
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• irinotecan hydrochloride

• paclitaxel

Locations

Country	Name	City	State
United States	Yale Comprehensive Cancer Center	New Haven	Connecticut
United States	Northwestern Connecticut Oncology-Hematology Associates - Torrington	Torrington	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,