Phase II Study of RFS 2000 in Relapsed NSCLC
18 Years
N/A
Both
Lung Cancer
Trial Information
Phase II Study of RFS 2000 in Relapsed NSCLC
OBJECTIVES: I. Determine the response rate, time to progression and overall survival of
patients with recurrent non-small cell lung cancer when treated with nitrocamptothecin. II.
Assess the toxicities and pharmacokinetics of this regimen in these patients.
OUTLINE: Patients receive oral nitrocamptothecin daily on days 1-5. Treatment continues
weekly in the absence of disease progression or unacceptable toxicity. Patients are followed
for survival.
PROJECTED ACCRUAL: A total of 20-55 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed recurrent non-small
cell lung cancer No more than one prior chemotherapy treatment Bidimensionally measurable
disease No prior radiotherapy to target lesion OR Progression since prior radiotherapy
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL ALT/AST no greater than
3 times upper limit of normal (ULN) (no greater than 5 times ULN in case of liver
metastases) Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least
50 mL/min Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use
effective contraception No uncontrolled serious medical or psychiatric illness
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics At least 3 weeks since prior chemotherapy and recovered No prior
camptothecin Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At
least 3 weeks since prior radiotherapy and recovered Surgery: At least 2 weeks since prior
major surgery
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Show-Li Sun, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Astex Pharmaceuticals
Authority:
United States: Federal Government
Study ID:
CDR0000067908
NCT ID:
NCT00005872
Start Date:
May 1999
Completion Date:
Related Keywords:
- Lung Cancer
- recurrent non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| SuperGen, Incorporated | Dublin, California 94568 |
