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


Condition Intervention Phase
Lung Cancer Drug: carboplatin Drug: irinotecan Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Phase II Study of Irinotecan and Carboplatin in Metastatic or Relapsed Small-Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 80
Study Start Date: October 2001
Study Completion Date: January 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00387660     History of Changes
Obsolete Identifiers: NCT00462800
Other Study ID Numbers: UCDCC-124
P30CA093373 ( US NIH Grant/Contract Award Number )
PFIZER-Z1000752 ( Other Grant/Funding Number: Pfizer )
Study First Received: October 12, 2006
Results First Received: January 13, 2017
Last Updated: March 20, 2017

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
Camptothecin
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 23, 2017