Clinical trial NCT00004924: Paclitaxel and Irinotecan in Treating Patients With Advanced Non-small Cell Lung Cancer
Official title: Phase II Trial of Irinotecan Plus Paclitaxel in Patients With Advanced Nonsmall Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Comprehensive Cancer Center
state: Connecticut
city: Torrington
country: United States
facility: Northwestern Connecticut Oncology-Hematology Associates - Torrington
state: Connecticut
Study officials:
affiliation: Yale University
name: John R. Murren, MD
role: STUDY_CHAIR
References: