Irinotecan and Carboplatin in Treating Patients With Newly Diagnosed Extensive-Stage Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00104793
First received: March 3, 2005
Last updated: May 29, 2013
Last verified: October 2007
  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 irinotecan together with carboplatin may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin works in treating patients with newly diagnosed extensive-stage small cell lung cancer.


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

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Weekly Irinotecan and Carboplatin in Extensive-Stage Small-Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]

Estimated Enrollment: 55
Study Start Date: June 2003
Study Completion Date: November 2008
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the response rate in patients with newly diagnosed, previously untreated extensive stage small cell lung cancer treated with irinotecan and carboplatin.

Secondary

  • Determine the progression-free and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive irinotecan IV and carboplatin IV on days 1 and 8. Treatment repeats every 21 days for 6 courses.

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed small cell lung cancer

    • Extensive stage disease
  • Newly diagnosed, treatment-naive disease
  • At least 1 unidimensionally measurable lesion
  • No massive pleural or pericardial effusion by chest CT scan

    • Manageable effusions allowed

PATIENT CHARACTERISTICS:

Age

  • Over 18

Performance status

  • ECOG 0-2

Life expectancy

  • More than 3 months

Hematopoietic

  • WBC ≥ 3,000/mm^3
  • Absolute granulocyte count ≥ 1,500/mm^3
  • Hemoglobin ≥ 9.0 g/dL

Hepatic

  • ALT or AST ≤ 2 times upper limit of normal
  • Bilirubin ≤ 1.5 mg/dL

Renal

  • Creatinine normal

Cardiovascular

  • No myocardial infarction within the past year
  • No uncontrolled hypertension
  • No unstable angina
  • No congestive heart failure
  • No ventricular arrhythmia requiring medical intervention
  • No other serious cardiovascular disease

Pulmonary

  • Arterial oxygen pressure (Pa O_2) ≥ 70 mm Hg
  • No interstitial pneumonitis or pulmonary fibrosis by chest x-ray

Other

  • Not pregnant or nursing
  • No uncontrolled diabetes
  • No severe infection
  • No paralytic or obstructive ileus
  • No serious diarrhea
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix that is in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy to the chest

    • Other prior radiotherapy allowed

Surgery

  • At least 2 weeks since prior surgery and recovered
  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: NCT00104793

Locations
Japan
National Hospital Organization - Dohoku National Hospital
Asahikawa, Hokkaido, Japan, 070-0901
Fujisawa City Hospital
Fujisawa, Kanagawa, Japan, 251-8550
Kurashiki Central Hospital
Kurashiki-shi, Okayama, Japan, 710-8602
Osaka General Medical Center
Osaka-shi, Osaka, Japan, 558-0056
National Hospital Organization - Osaka National Hospital
Sakai, Osaka, Japan, 591-8555
Takatsuki Red Cross Hospital
Takatsuki, Osaka, Japan, 569-1096
Yao Tokusyu-kai General Hospital
Yao, Osaka, Japan, 561-0072
Gunma Cancer Center
Gunma, Japan, 373-8550
National Hospital Organization - Medical Center of Kure
Hiroshima, Japan, 737-0023
Osaka Kosei Nenkin Hospital
Osaka, Japan, 553-0003
Tokyo Medical and Dental University
Tokyo, Japan, 113-8519
Sponsors and Collaborators
Japan Multinational Trial Organization
Investigators
Study Chair: Tadashi Mio, MD Kyoto University
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00104793     History of Changes
Other Study ID Numbers: JMTO-LC02-02, CDR0000415703
Study First Received: March 3, 2005
Last Updated: May 29, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
extensive stage 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
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014