Combination Chemotherapy Followed by Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003111
• Other study ID #: CDR0000065855
• Secondary ID: YALE-HIC-9317NCI
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: July 23, 2013
• Start date: April 1997
• Est. completion date: April 2004

Study information

• Verified date: August 2009
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with irinotecan and cisplatin followed by surgery in treating patients with stage IIIA non-small cell lung cancer.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2004
• Est. primary completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• carboplatin

• cisplatin

• irinotecan hydrochloride

• paclitaxel

Procedure:
• neoadjuvant therapy

• surgical procedure

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	Yale Comprehensive Cancer Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,