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Phase II Study of Weekly Irinotecan and Carboplatin in Extensive-Stage Small-Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

Phase II Study of Weekly Irinotecan and Carboplatin in Extensive-Stage Small-Cell Lung Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response

Safety Issue:

No

Principal Investigator

Tadashi Mio, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Kyoto University

Authority:

United States: Federal Government

Study ID:

JMTO-LC02-02

NCT ID:

NCT00104793

Start Date:

June 2003

Completion Date:

November 2008

Related Keywords:

  • Lung Cancer
  • extensive stage small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

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