Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	Over 18	NCI	YALE-HIC-10740 NCI-G00-1701, NCT00004924

Objectives

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

Entry 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

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

Patient Characteristics:

Age:

• Over 18

Performance status:

• ECOG 0-2

Life expectancy:

• At least 3 months

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm³
• Platelet count greater than 100,000/mm³

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Yale Cancer Center

John Murren, MD, Protocol chair(Contact information may not be current)		Ph: 203-785-4095; 866-925-3226

Registry Information
Official Title		Phase II Trial of Irinotecan Plus Paclitaxel in Patients With Advanced Nonsmall Cell Lung Cancer
Trial Start Date		1999-03-03
Registered in ClinicalTrials.gov		NCT00004924
Date Submitted to PDQ		2000-01-13
Information Last Verified		2005-02-14
NCI Grant/Contract Number		P30-CA16359

Back to Top