Irinotecan and Gemcitabine in Treating Patients With Recurrent or Progressive Stage III or Stage IV Non-Small Cell Lung Cancer

Roswell Park Comprehensive Cancer Center

Status and phase

Completed

Phase 2

Conditions

Lung Cancer

Treatments

Drug: gemcitabine hydrochloride

Drug: irinotecan hydrochloride

Study type

Interventional

Funder types

Other

Identifiers

NCT00182806

RPCI-I-31204

CDR0000441226

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy, such as irinotecan and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Irinotecan may also increase the effectiveness of gemcitabine. Giving irinotecan together with gemcitabine may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving irinotecan together with gemcitabine works in treating patients with recurrent or progressive stage III or stage IV non-small cell lung cancer.

Full description

OBJECTIVES:

Primary

Determine the objective response rate (complete and partial response) in patients with recurrent or progressive stage IIIA-IV non-small cell lung cancer treated with irinotecan and gemcitabine.

Secondary

Determine the median time to progression in patients treated with this regimen.

OUTLINE: This a non-randomized, open-label, multicenter study.

Patients receive irinotecan IV over 90 minutes on days 1 and 8 and gemcitabine IV over 30 minutes on days 2 and 9. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 1 month and then every 8 weeks thereafter.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 16 months.

Enrollment

38 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), meeting 1 of the following stage criteria:
- Stage IIIA or IIIB disease
  - Progressive disease
- Stage IV disease
  - Failed 1 prior platinum-based chemotherapy regimen, including adjuvant therapy
Measurable or evaluable disease, as defined by 1 of the following criteria:
- At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR > 10 mm by spiral CT scan
- Lesions apparent on CT scan that do not meet the criterion for measurability
Brain metastases allowed provided patient has received definitive therapy for metastases, is asymptomatic, and has extra-CNS metastases

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-1

Life expectancy

More than 12 weeks

Hematopoietic

WBC ≥ 3,000/mm^3
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3

Hepatic

AST and ALT ≤ 1.5 times normal
Alkaline phosphatase < 1.5 times normal
Bilirubin ≤ 1.3 mg/dL

Renal

Creatinine ≤ 1.6 mg/dL OR
Creatinine clearance ≥ 50 mL/min

Cardiovascular

No unstable angina
No congestive heart failure
No myocardial infarction within the past 3 months
No life-threatening ventricular arrhythmia requiring maintenance therapy

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment
No uncontrolled seizure disorder
No uncontrolled diabetes mellitus
No active infection requiring systemic therapy
No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
No other unstable or serious condition

PRIOR CONCURRENT THERAPY:

Biologic therapy