Lung Cancer Clinical Trial

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

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

28

Study ID:

NCT00004924

Recruitment Status:

Completed

Sponsor:

Yale University

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 2 Locations for this study

See Locations Near You

Yale Comprehensive Cancer Center
New Haven Connecticut, 06520, United States
Northwestern Connecticut Oncology-Hematology Associates - Torrington
Torrington Connecticut, 06790, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

28

Study ID:

NCT00004924

Recruitment Status:

Completed

Sponsor:


Yale University

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider