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Irinotecan and Carboplatin as First-Line Therapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00469898
  Purpose

RATIONALE: Drugs used in chemotherapy, such as irinotecan and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

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 II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Carboplatin Irinotecan Irinotecan hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Designated as safety issue: Yes ]
  • Tolerability [ Designated as safety issue: Yes ]
  • Feasibility [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 54
Study Start Date: December 2003
Estimated Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the antitumor efficacy of irinotecan hydrochloride and carboplatin as first-line therapy 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 hydrochloride 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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed small cell lung cancer (SCLC)

    • Extensive stage disease
  • 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
  • Bilirubin ≤ 1.5 mg/dL
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
  • Creatinine ≤ 2.0 mg/dL
  • Hemoglobin ≥ 9.0 g/dL
  • No coexisting medical condition that would preclude study compliance
  • No known Gilbert's disease
  • No uncontrolled diabetes mellitus, defined as random blood sugar > 300 mg/dL or > 16.6 mmol/L
  • Not pregnant or nursing
  • Negative pregnancy test
  • No secondary active malignancy except for any in situ cancer, adequately treated basal cell or squamous cell skin cancer, or any cancer from which the patient has been disease-free for ≥ 2 years

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Prior radiotherapy therapy allowed
  • At least 7 days since prior phenytoin, phenobarbital, carbamazepine, or other enzyme-inducing anticonvulsant drugs

    • Concurrent gabapentin allowed
  • No prior systemic anticancer therapy for extensive stage SCLC, including chemotherapy, antibody therapy, immunotherapy, gene therapy, cytokine therapy, vaccine therapy, or experimental agents
  • At least 7 days since prior and no concurrent Hypericum perforatum extract (St. John's wort)
  • No concurrent inhibitors of vascular endothelial or epidermal growth factor pathways
  • No concurrent CNS radiotherapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00469898

Locations
United States, Tennessee
Baptist Regional Cancer Center at Baptist Hospital of East Tennessee
Knoxville, Tennessee, United States, 37901
MBCCOP - Meharry Medical College - Nashville
Nashville, Tennessee, United States, 37208
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
West Tennessee Cancer Center at Jackson-Madison County General Hospital
Jackson, Tennessee, United States, 38301
Canada
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, Canada, V52 4
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Principal Investigator: Alan B. Sandler, MD Vanderbilt-Ingram Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Responsible Party: Vanderbilt-Ingram Cancer Center ( Alan B. Sandler )
Study ID Numbers: CDR0000543773, VU-VICC-THO-0321
Study First Received: May 3, 2007
Last Updated: December 19, 2008
ClinicalTrials.gov Identifier: NCT00469898  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
extensive stage small cell lung cancer

Study placed in the following topic categories:
Thoracic Neoplasms
Carcinoma, Neuroendocrine
Irinotecan
Carboplatin
Camptothecin
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Neoplasms, Nerve Tissue
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009