Phase II Study of Irinotecan Followed by Gemcitabine in NSCLC Following Failure of Platinum Based Therapy
18 Years
N/A
Both
Lung Cancer
Trial Information
Phase II Study of Irinotecan Followed by Gemcitabine in NSCLC Following Failure of Platinum Based Therapy
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.
Inclusion 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
- Not specified
Chemotherapy
- See Disease Characteristics
- At least 3 weeks since prior chemotherapy
- Prior irinotecan allowed
- No prior gemcitabine
- No more than 1 prior chemotherapy regimen for NSCLC, excluding gefitinib
- No other concurrent chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery
- Not specified
Other
- More than 1 month since prior participation in another clinical trial using an
investigational agent
- No other concurrent investigational agents
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Objective response (complete, partial, and stable disease)
Safety Issue:
No
Principal Investigator
Nithya Ramnath, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Roswell Park Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000441226
NCT ID:
NCT00182806
Start Date:
September 2004
Completion Date:
July 2008
Related Keywords:
- Lung Cancer
- recurrent non-small cell lung cancer
- stage IIIA non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- stage IV non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
