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

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ClinicalTrials.gov Identifier: NCT00387660
Recruitment Status : Completed
First Posted : October 13, 2006
Results First Posted : May 1, 2017
Last Update Posted : January 10, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Pfizer
Information provided by (Responsible Party):
University of California, Davis

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.


Condition or disease Intervention/treatment Phase
Lung Cancer Drug: carboplatin Drug: irinotecan Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Irinotecan and Carboplatin in Metastatic or Relapsed Small-Cell Lung Cancer
Study Start Date : October 2001
Actual Primary Completion Date : August 2008
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
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
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: Relapsed SCLC
Irinotecan 150 mg/m2 (intravenous), every 21 days + Carboplatin AUC = 5 mg/ml x min (intravenous, every 21 days for 6 cycles
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00387660


Locations
United States, California
University of California Davis Cancer Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
National Cancer Institute (NCI)
Pfizer
Investigators
Study Chair: Derick H. Lau, MD University of California, Davis

Publications of Results:
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00387660     History of Changes
Obsolete Identifiers: NCT00462800
Other Study ID Numbers: UCDCC-124
200210637 ( Other Identifier: UC Davis )
PFIZER-Z1000752 ( Other Grant/Funding Number: Pfizer )
P30CA093373 ( U.S. NIH Grant/Contract )
First Posted: October 13, 2006    Key Record Dates
Results First Posted: May 1, 2017
Last Update Posted: January 10, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, Davis:
extensive stage small cell lung cancer
limited stage small cell lung cancer
recurrent 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
Camptothecin
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action