Irinotecan and Carboplatin in Treating Patients With Metastatic or Recurrent Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00387660
First received: October 12, 2006
Last updated: December 16, 2011
Last verified: December 2011

October 12, 2006
December 16, 2011
October 2001
August 2008   (final data collection date for primary outcome measure)
Overall response rate [ Time Frame: Evidence of disease progression during the study ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00387660 on ClinicalTrials.gov Archive Site
  • Median survival of patients treated with this regimen [ Time Frame: Survival data collected during the study ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: During study treatment ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Irinotecan and Carboplatin in Treating Patients With Metastatic or Recurrent Small Cell Lung Cancer
Phase II Study of Irinotecan and Carboplatin in Metastatic or Relapsed Small-Cell Lung Cancer

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 in treating patients with metastatic or recurrent small cell lung cancer.

OBJECTIVES:

  • Determine the response rates in patients with metastatic or recurrent small cell lung cancer treated with irinotecan hydrochloride and carboplatin.
  • Determine the median survival of patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy (yes vs no) and disease stage (metastatic vs relapsed).

Patients receive irinotecan hydrochloride IV over 90 minutes and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
  • Drug: carboplatin
    Patients receive carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
    Other Names:
    • Paraplatin
    • Paraplatin-AQ
  • Drug: irinotecan hydrochloride
    Patients receive irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
    Other Names:
    • Camptosar®
    • Camptothecin-11
    • CPT-11
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
January 2009
August 2008   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed small cell lung cancer, meeting 1 of the following criteria:

    • Previously untreated metastatic or extensive disease

      • Malignant pleural effusion or multifocal lung disease is considered metastatic or extensive disease
      • Prior radiotherapy allowed
    • Recurrent disease

      • Limited, metastatic, or extensive disease
      • Relapsed after prior chemotherapy, excluding irinotecan hydrochloride

        • At least 90 days since prior chemotherapy
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 1 cm by physical examination or radiographic techniques
  • Known brain metastases allowed

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 3 months
  • WBC > 3,000/mm³
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9.0 g/dL
  • Bilirubin ≤ 1.5 mg/dL
  • SGOT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of study treatment
  • No medical disease that, in the opinion of the investigator, would preclude study treatment

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 10 days since prior radiotherapy (including brain)
  • No prior irinotecan hydrochloride
  • At least 2 weeks since prior and no concurrent anticonvulsants
  • No concurrent radiotherapy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00387660
CDR0000505840, P30CA093373, UCDCC-124, UCDCC-200210637-5, PFIZER-Z1000752
No
University of California, Davis
University of California, Davis
National Cancer Institute (NCI)
Study Chair: Derick H. Lau, MD University of California, Davis
University of California, Davis
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP