Phase II Clinical and Laboratory Study of Irinotecan/Cisplatin Chemotherapy Followed by Surgery in Stage III NSCLC
18 Years
N/A
Both
Lung Cancer
Trial Information
Phase II Clinical and Laboratory Study of Irinotecan/Cisplatin Chemotherapy Followed by Surgery in Stage III NSCLC
OBJECTIVES:
- Evaluate the efficacy of irinotecan based chemotherapy in patients with stage IIIA
non-small cell lung cancer.
- Investigate the phenotypic changes induced in the tumor by this treatment.
OUTLINE: Patients receive IV cisplatin over 30 minutes followed by IV irinotecan over 30
minutes on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for 3 courses until
disease progression. Once potential candidates for resectability are determined, patients
undergo thoracotomy or concurrent chemotherapy/radiation therapy within 6 weeks of
completing the last course of chemotherapy. Following resection, patients responding to
chemotherapy receive 3 additional courses of IV carboplatin and paclitaxel over 3 hours.
Patients may undergo local irradiation beginning with the second course of carboplatin and
paclitaxel. Chemotherapy ceases if disease remains stable after 8 weeks.
Patients are followed every 3 months for the first year after treatment, then every 6 months
thereafter for survival.
PROJECTED ACCRUAL: This study will accrue 20 patients over 18 months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed, previously untreated stage IIIa (T1-2 N2 M0) non-small cell
lung cancer
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Total bilirubin no greater than 1.5 mg/dL
Renal:
- Creatinine clearance at least 55 mL/min
Other:
- Not HIV positive
- No active infections
- Not pregnant or lactating
- Effective contraception required of fertile patients during study participation
- No coexisting medical condition
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
- No concurrent chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiation therapy
- No concurrent radiation therapy
Surgery:
- Not specified
Other:
- No concurrent use of investigational agents during study participation
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
John R. Murren, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Yale University
Authority:
United States: Federal Government
Study ID:
CDR0000065855
NCT ID:
NCT00003111
Start Date:
April 1997
Completion Date:
April 2004
Related Keywords:
- Lung Cancer
- stage IIIA non-small cell lung cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Yale Comprehensive Cancer Center | New Haven, Connecticut 06520-8028 |
