A Phase II Trial of Carboplatin and Irinotecan (CPT-11) as First-Line Therapy for Patients With Extensive Stage Small Cell Lung Cancer
18 Years
N/A
Both
Lung Cancer
Trial Information
A Phase II Trial of Carboplatin and Irinotecan (CPT-11) as First-Line Therapy for Patients With Extensive Stage Small Cell Lung Cancer
OBJECTIVES:
Primary
- To examine the anti-tumor efficacy of the combination of Irinotecan (CPT-11) and
Carboplatin as first-line therapy as assessed by response rate in patients with
chemo-naïve extensive stage small cell lung cancer.
Secondary
- Determine the safety, tolerability, and feasibility of this regimen in these patients.
- Determine the time to progression in patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter, open-label study.
Patients receive irinotecan IV over 30-90 minutes on days 1 and 8 and carboplatin IV on day
1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression
or unacceptable toxicity.
After completion of study treatment, patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.
Inclusion Criteria:
- Histologically or cytologically confirmed small cell lung cancer (SCLC)
- Extensive stage small cell lung cancer
- Must have ≥ 1 unidimensionally measurable lesion (longest diameter to be recorded) ≥
20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
- Lesion cannot be from a previously irradiated area
- Lesions that are considered nonmeasurable include the following:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Lymphangitis cutis/pulmonis
- Abdominal masses not confirmed and followed by imaging techniques
- Cystic lesions
- Tumor lesions in a previously irradiated area
- No brain metastasis or carcinomatous meningitis unless stable and asymptomatic
PATIENT CHARACTERISTICS
- ECOG performance status 0-2
- Life expectancy ≥ 3 months
- ANC ≥ 1,500/mm³
- Platelet count > 100,000/mm³
- Serum bilirubin ≤ 1.5 mg/dL
- AST/SGOT ≤ 2.5 times upper limit of normal (ULN) (or ≤ 5 times ULN if liver
metastases present)
- Serum creatinine ≤ 2.0 mg/dl
- Hemoglobin ≥ 9.0 g/dl
Exclusion Criteria:
- CNS metastasis excluded unless: stable and asymptomatic
- Coexisting medical condition that would preclude study compliance
- Patients with Gilbert's disease
- Uncontrolled diabetes mellitus, defined as random blood sugar ≥ 300 mg/dl or > 16.6
mmol/L
- Patients who do not discontinue phenytoin, phenobarbitol, carbamazipine, or other
enzyme-inducing anticonvulsant drugs at least 7 days prior to first treatment dose on
study. Gabapentin is permitted
- Patients who do not discontinue St. John's Wort prior to first treatment dose on
study.
- Patients who are pregnant or breast feeding
- Concomitant second active malignancy except for any in situ cancer or adequately
treated basal cell or squamous cell skin cancer or any cancer from which the patients
has been disease-free for at least 2 years
- No administration of any prior systemic anticancer therapy for extensive stage SCLC
such as: chemotherapy, antibody therapy, immunotherapy, gene therapy, vaccine
therapy, cytokine therapy, or other experimental agents. Concurrent use of other
anticancer therapy including inhibitors of vascular endothelial or epidermal growth
factor pathways is prohibited. Prior radiation is allowed
- Symptomatic brain metastasis or carcinomatous meningitis
PRIOR CONCURRENT THERAPY:
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Patient Response
Outcome Description:
Patient response to treatment: Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started Complete response (CR): disappearance of all target lesions Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD
Outcome Time Frame:
1.66 months (average duration, on treatment date to best response date)
Safety Issue:
No
Principal Investigator
Leora Horn, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Vanderbilt-Ingram Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
VICC THO 0321
NCT ID:
NCT00469898
Start Date:
December 2003
Completion Date:
July 2010
Related Keywords:
- Lung Cancer
- extensive stage small cell lung cancer
- Lung Neoplasms
- Small Cell Lung Carcinoma
Name | Location |
|---|---|
| Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
| MBCCOP - Meharry Medical College - Nashville | Nashville, Tennessee 37208-3599 |
| West Tennessee Cancer Center at Jackson-Madison County General Hospital | Jackson, Tennessee 38301 |
| Owensboro Medical Health System | Owensboro, Kentucky 42303 |
| Memorial Health Care System | Chattanooga, Tennessee 37404 |
| Tennessee Cancer Specialists | Knoxville, Tennessee 37920 |
| St. Thomas Health Services | Nashville, Tennessee 37205 |
