Clinical trial NCT00469898: Irinotecan and Carboplatin as First-Line Therapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Official title: A Phase II Trial of Carboplatin and Irinotecan (CPT-11) as First-Line Therapy for Patients With Extensive Stage Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: extensive stage small cell lung cancer
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-05-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: The general results of combining irinotecan and platin-based chemotherapies have been very encouraging. As the toxicity profile associated with carboplatin is preferable over cisplatin it is our expectation that patients and physicians would prefer to use this combination if it is equally or more efficacious. To date there has been no agreement regarding the optimal combination of these agents. Based on the trials described in the protocol and our experience with carboplatin/irinotecan in the treatment of non-small cell lung cancer the present trial will utilize a 21-day cycle of irinotecan 50 mg/m2 given on days 1 and 8 and carboplatin AUC 5 (based on the Calvert formula) on day 1.

PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin works as first-line therapy in treating patients with extensive-stage small cell lung cancer.

Detailed description: 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.

Eligibility criteria: 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:

Primary outcomes:
measure: Patient Response
timeFrame: 1.66 months (average duration, on treatment date to best response date)
Secondary outcomes:
measure: Number of Patients With Adverse Events
timeFrame: date off treatment or progression of disease, up to 18 weeks
measure: Time to Progression
timeFrame: 9.9 months (on study date to progression)
measure: Overall Survival
timeFrame: On study date to death
Other outcomes:
Locations:
city: Owensboro
country: United States
facility: Owensboro Medical Health System
state: Kentucky
city: Chattanooga
country: United States
facility: Memorial Health Care System
state: Tennessee
city: Jackson
country: United States
facility: West Tennessee Cancer Center at Jackson-Madison County General Hospital
state: Tennessee
city: Knoxville
country: United States
facility: Tennessee Cancer Specialists
state: Tennessee
city: Nashville
country: United States
facility: St. Thomas Health Services
state: Tennessee
city: Nashville
country: United States
facility: MBCCOP - Meharry Medical College - Nashville
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency - Vancouver Cancer Centre
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Leora Horn, MD
role: PRINCIPAL_INVESTIGATOR
References: