A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Stage IIIb or Stage IV Non-Small Cell Lung Cancer as First Line Therapy
18 Years
N/A
Both
Lung Cancer
Trial Information
A Phase II Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Patients With Stage IIIb or Stage IV Non-Small Cell Lung Cancer as First Line Therapy
OBJECTIVES: I. Determine the antitumor activity of DX-8951f in previously untreated patients
with stage IIIB or IV non-small cell lung cancer. II. Evaluate the quantitative and
qualitative toxic effects of this regimen in these patients. III. Evaluate the
pharmacokinetics of this regimen in these patients. IV. Assess the time to progression and
survival status of these patients.
OUTLINE: This is a multicenter study. Patients receive DX-8951f IV over 30 minutes daily for
5 days. Treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease
progression or unacceptable toxicity. Patients are followed every 3 months for survival.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed unresectable,
metastatic, or recurrent non-small cell lung cancer Stage IIIB or IV Measurable disease No
known brain metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet
count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT or SGPT
no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if liver
metastases present) Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No active
congestive heart failure Other: Not pregnant or nursing Negative pregnancy test Fertile
patients must use effective contraception No concurrent serious infection No other
malignancy within past 5 years except nonmelanomatous skin cancer No overt psychosis,
mental disability, or incompetence No life threatening illness
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy:
No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified
Radiotherapy: No prior radiotherapy to greater than 25% of the bone marrow No concurrent
radiotherapy Surgery: No concurrent surgery Other: At least 28 days since prior
investigational drugs No other concurrent investigational drugs during or within 28 days
after final dose of study drug No concurrent drugs that induce or inhibit CYP3A enzyme
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Nick Thatcher, PhD, FRCP
Investigator Role:
Study Chair
Investigator Affiliation:
Christie Hospital NHS Foundation Trust
Authority:
United States: Federal Government
Study ID:
DAIICHI-8951E-PRT017
NCT ID:
NCT00005091
Start Date:
February 1999
Completion Date:
August 2003
Related Keywords:
- Lung Cancer
- recurrent non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- stage IV non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|
