Cisplatin and cisplatin and paclitaxel in Carcinoma, Non-Small-Cell Lung and Lung Neoplasms - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a Phase II study of paclitaxel administered as a 96-hour (4 day) continuous infusion with a bolus of cisplatin followed by chest radiotherapy for previously untreated patients with stage III non-small cell lung cancer (NSCLC). The non-small cell lung cancer tissue obtained prior to the start of treatment will be studied for mutations of the p53 gene. The goal of this phase II study is to determine the response rate to 4 cycles of infusional paclitaxel and bolus cisplatin for patients with stage III NSCLC. The response will again be assessed following completion of 6000 cGy of chest radiotherapy and the patients will then be followed for survival. The relationship between the presence or absence of a p53 mutation and the sensitivity of the patient's tumors to paclitaxel plus cisplatin and chest radiation will be studied. In addition, the plasma levels of paclitaxel will be measured, and the in vitro paclitaxel chemosensitivity of the tumor cells will be determined from as many patients as possible. This will allow further study of the relationship between p53 status, in vitro drug sensitivity, achievable plasma concentrations of paclitaxel, and patients' response to therapy.

Study Type

Interventional

Enrollment

50

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Maryland
  - Bethesda, Maryland, United States, 20892
    - National Cancer Institute (NCI)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

Histologically confirmed non-small cell lung cancer of the following histologies: Squamous cell carcinoma, Adenocarcinoma, Large cell carcinoma, No mixed small/non-small cell carcinoma with predominant small cell component.

Unresectable stage IIIA/B disease confined to thorax including:

Microscopic disease involvement following attempted surgery and limited to anatomic areas corresponding to stage III disease (N2-3, T3-4).

Surgically treated stage I/II disease with histologic or cytologic proof of relapse and limited to anatomic areas corresponding to stage III disease (N2-3, T3-4).

T3, N0 tumor extending directly to the chest wall considered resectable and not eligible.

No stage IIIB disease with pleural effusion visible on chest x-ray unless related to a previous thoracotomy.

No typical carcinoid or mesothelioma.

Measurable disease preferred but not required.

PRIOR/CONCURRENT THERAPY:

No prior chemotherapy or thoracic radiotherapy.

PATIENT CHARACTERISTICS:

Age: 18 and over.

Performance status: ECOG 0-2.

Hematopoietic:

AGC greater than 2,000.

Platelets greater than 100,000.

Hepatic: Bilirubin no greater than 1.5 mg/dL.

Renal: Creatinine no greater than 1.5 mg/dL.

Cardiovascular:

No symptomatic heart disease including: Less than fully compensated congestive cardiac failure, Significant arrhythmias e.g.: Greater than first-degree heart block, Uncontrolled and symptomatic atrial dysrhythmia except sinus, bradycardia or sustained ventricular tachycardia, Myocardial infarction within 3 months.

Pulmonary: No major uncontrolled active infection (unless due to obstructed bronchus).

OTHER:

No major active psychiatric problem requiring hospitalization or psychotropic medication such as phenothiazines.

No prior second malignancy within 5 years except: nonmelanomatous skin cancer, In situ carcinoma of the cervix.

No pregnant or nursing women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1996

Study Completion

June 1, 2000

Study Registration Dates

First Submitted

November 3, 1999

First Submitted That Met QC Criteria

December 9, 2002

First Posted (Estimate)

December 10, 2002

Study Record Updates

Last Update Posted (Estimate)

March 4, 2008

Last Update Submitted That Met QC Criteria

March 3, 2008

Last Verified

March 1, 2000

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

960054
96-C-0054

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Phase II Neoadjuvant Trial of a Continuous Infusion of Paclitaxel Plus Cisplatin Followed by Chest Radiotherapy for Patients With Stage III Non-Small Cell Lung Cancer