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Phase II Clinical and Laboratory Study of Irinotecan/Cisplatin Chemotherapy Followed by Surgery in Stage III NSCLC


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

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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 CenterNew Haven, Connecticut  06520-8028