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

NCT00387660

Last updated date
Study Location
University of California Davis Cancer Center
Sacramento, California, 95817, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Lung Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years

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Advanced Information
Descriptive Information
Brief Title  ICMJE Irinotecan and Carboplatin in Treating Patients With Metastatic or Recurrent Small Cell Lung Cancer
Official Title  ICMJE Phase II Study of Irinotecan and Carboplatin in Metastatic or Relapsed Small-Cell Lung Cancer
Brief Summary

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.

Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer
Intervention  ICMJE
  • 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
    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
Study Arms  ICMJE
  • Experimental: Metastatic SCLC
    Irinotecan 200 mg/m2, every 21 days (intravenous) + Carboplatin AUC = 5 mg/ml x min (intravenous), every 21 days for 6 cycles
    Interventions:
    • Drug: carboplatin
    • Drug: irinotecan
  • Experimental: Relapsed SCLC
    Irinotecan 150 mg/m2 (intravenous), every 21 days + Carboplatin AUC = 5 mg/ml x min (intravenous, every 21 days for 6 cycles
    Interventions:
    • Drug: carboplatin
    • Drug: irinotecan
Publications * Chen G, Huynh M, Fehrenbacher L, West H, Lara PN Jr, Yavorkovsky LL, Russin M, Goldstein D, Gandara D, Lau D. Phase II trial of irinotecan and carboplatin for extensive or relapsed small-cell lung cancer. J Clin Oncol. 2009 Mar 20;27(9):1401-4. doi: 10.1200/JCO.2008.20.2127. Epub 2009 Feb 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 20, 2017)
80
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • White Blood Cells > 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00387660
Other Study ID Numbers  ICMJE UCDCC-124
200210637 ( Other Identifier: UC Davis )
PFIZER-Z1000752 ( Other Grant/Funding Number: Pfizer )
P30CA093373 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, Davis
Study Sponsor  ICMJE University of California, Davis
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • Pfizer
Investigators  ICMJE
Study Chair:Derick H. Lau, MDUniversity of California, Davis
PRS Account University of California, Davis
Verification Date January 2018

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