Irinotecan and Carboplatin as First-Line Therapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Leora Horn, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00469898
First received: May 3, 2007
Last updated: July 20, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: Carboplatin
Drug: irinotecan hydrochloride
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • Patient Response [ Time Frame: 1.66 months (average duration, on treatment date to best response date) ] [ Designated as safety issue: No ]

    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



Secondary Outcome Measures:
  • Number of Patients With Adverse Events [ Time Frame: date off treatment or progression of disease, up to 18 weeks ] [ Designated as safety issue: Yes ]
    Number of participants with adverse events, according to grade of event, using the NCI Common Toxicity Criteria (version 2.0) grading system to assign a grade to each event

  • Time to Progression [ Time Frame: 9.9 months (on study date to progression) ] [ Designated as safety issue: No ]
    Time to progression in months

  • Overall Survival [ Time Frame: On study date to death ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: December 2003
Study Completion Date: July 2010
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Therapeutic Intervention
Lung cancer patients will be treated for four 3-week cycles (12 weeks) in the absence of progressive disease, unacceptable toxicity, or withdrawal of patient consent. Up to two additional cycles may be administered at the discretion of the treating physician. If at treatment withdrawal the disease has responded or is stable, the patient will continue to be followed for efficacy (i.e. until progressive disease)at 8 week intervals. Following the diagnosis of progressive disease, patients will be followed every two months for survival.
Drug: Carboplatin

Carboplatin dosage calculation to be given on day 1, every 21 days:

Carboplatin (mg) = (AUC of 5) x (GFR + 25)

*up to 6 cycles at physician's discretion

Other Name: Paraplatin
Drug: irinotecan hydrochloride

50 mg/m2 IV on days 1 and 8 every 21 days

Should be infused IV over 30- 90 minutes.

Other Names:
  • Irinotecan
  • Camptosar
  • CPT-11

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00469898

Locations
United States, Kentucky
Owensboro Medical Health System
Owensboro, Kentucky, United States, 42303
United States, Tennessee
Memorial Health Care System
Chattanooga, Tennessee, United States, 37404
West Tennessee Cancer Center at Jackson-Madison County General Hospital
Jackson, Tennessee, United States, 38301
Tennessee Cancer Specialists
Knoxville, Tennessee, United States, 37901
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
St. Thomas Health Services
Nashville, Tennessee, United States, 37205
MBCCOP - Meharry Medical College - Nashville
Nashville, Tennessee, United States, 37208
Canada
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, Canada, V52 4
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Principal Investigator: Leora Horn, MD Vanderbilt-Ingram Cancer Center
  More Information

No publications provided

Responsible Party: Leora Horn, MD, Assistant Professor of Medicine; Assistant Director, Educator Development Program; Clinical Director, Thoracic Oncology Program; Medical Oncologist, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00469898     History of Changes
Other Study ID Numbers: VICC THO 0321, VU-VICC-THO-0321
Study First Received: May 3, 2007
Results First Received: October 11, 2010
Last Updated: July 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt-Ingram Cancer Center:
extensive stage small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Irinotecan
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014