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Phase II Study of RFS 2000 in Relapsed NSCLC


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

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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