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

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Pfizer
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00387660
First received: October 12, 2006
Last updated: March 20, 2017
Last verified: March 2017
October 12, 2006
March 20, 2017
October 2001
August 2008   (Final data collection date for primary outcome measure)
Overall Response Rate [ Time Frame: Up to 36 months ]
Per Response Evaluation Criteria In Solid Tumors Criteria for target lesions and assessed by radiographic techniques. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
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: Up to 36 months ]
    The length of time from the start of treatment that half of the patients in a group of patients diagnosed with the disease are still alive.
  • Number of Participants With Toxicity [ Time Frame: Up to 36 months ]
    All adverse events were graded according to the National Cancer InstituteCommon Toxicity Criteria, version 2.0. All 80 patients were assessable for toxicity at least for the first cycle.
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.

Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
    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
  • 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
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.
 
Completed
80
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
  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00387660
UCDCC-124
P30CA093373 ( U.S. NIH Grant/Contract )
PFIZER-Z1000752 ( Other Grant/Funding Number: Pfizer )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
University of California, Davis
University of California, Davis
  • National Cancer Institute (NCI)
  • Pfizer
Study Chair: Derick H. Lau, MD University of California, Davis
University of California, Davis
March 2017

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