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A Phase II Trial of Carboplatin and Irinotecan (CPT-11) as First-Line Therapy for Patients With Extensive Stage Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Lung Cancer

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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



- 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.


- 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


- 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

- 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

- 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


Type of Study:


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:


Principal Investigator

Leora Horn, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

December 2003

Completion Date:

July 2010

Related Keywords:

  • Lung Cancer
  • extensive stage small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma



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