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Paclitaxel Plus Radiation Therapy in Treating Patients With Untreated Stage III Non-small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
chemotherapy
paclitaxel
radiation therapy
Sponsored by
Vanderbilt-Ingram Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically proven previously untreated non-small cell lung cancer that is not amenable to potentially curative surgery due to the following: Direct invasion of the mediastinum, heart, great vessels, trachea, esophagus, vertebral body, or carina by tumor (T4) Cytologically positive scalene or supraclavicular nodes Mediastinal or contralateral hilar nodes 3 cm or greater on CT, with or without pathological confirmation Pathologically positive mediastinal or contralateral hilar nodes on mediastinoscopy or Chamberlain procedure (N2 or N3) Medically inoperable stage IIIA disease (e.g., resection would result in insufficient pulmonary volume) allowed No distant metastases No pleural effusion (regardless of fluid cytology) Evaluable disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 0-2 Hematopoietic: WBC normal Platelet count normal Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) Transaminases no greater than 2 times ULN Alkaline phosphatase no greater than 2 times ULN Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No significant coronary artery disease No documented myocardial infarction No angina, arrhythmia, or congestive heart failure requiring medication Pulmonary: FEV1 greater than 1 liter pO2 greater than 55 mm Hg on room air pCO2 less than 45 mm Hg on room air Other: No prior severe hypersensitivity reaction to products containing Cremaphor EL No clinical evidence of pre-existing polyneuropathy Not pregnant Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior thoracic irradiation Surgery: See Disease Characteristics Other: No concurrent medications known to alter cardiac conduction or cause bradycardia (e.g., digoxin, beta blockers, or calcium channel blockers)

Sites / Locations

  • University of Pennsylvania Cancer Center
  • Sarah Cannon-Minnie Pearl Cancer Center
  • Vanderbilt Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
May 1, 2013
Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00002519
Brief Title
Paclitaxel Plus Radiation Therapy in Treating Patients With Untreated Stage III Non-small Cell Lung Cancer
Official Title
PH I Continuous Infusion Taxol in Combination With Thoracic Radiation Therapy in Untreated Locally Advanced Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
January 1997 (undefined)
Primary Completion Date
January 2000 (Actual)
Study Completion Date
January 2000 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of chemotherapy with paclitaxel in combination with radiation therapy to the chest in patients with previously untreated stage III non-small cell lung cancer that cannot be surgically removed.
Detailed Description
OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of paclitaxel when combined with standard thoracic radiotherapy in patients with locally advanced non-small cell lung cancer. II. Determine the plasma levels of paclitaxel in these patients. III. Determine the effect of this regimen on the tumor cell cycle distribution in these patients. OUTLINE: This is a dose-escalation study of paclitaxel. Patients undergo standard thoracic radiotherapy 5 days a week for 7 weeks. Patients receive paclitaxel IV continuously beginning 48 hours before initiating radiotherapy and continuing until the last day of radiotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-5 patients receive escalating doses of paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 5 patients experience dose-limiting toxicity. Patients are followed monthly for 2 years. PROJECTED ACCRUAL: A total of 3-5 patients per dose level will be accrued for this study within 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
chemotherapy
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven previously untreated non-small cell lung cancer that is not amenable to potentially curative surgery due to the following: Direct invasion of the mediastinum, heart, great vessels, trachea, esophagus, vertebral body, or carina by tumor (T4) Cytologically positive scalene or supraclavicular nodes Mediastinal or contralateral hilar nodes 3 cm or greater on CT, with or without pathological confirmation Pathologically positive mediastinal or contralateral hilar nodes on mediastinoscopy or Chamberlain procedure (N2 or N3) Medically inoperable stage IIIA disease (e.g., resection would result in insufficient pulmonary volume) allowed No distant metastases No pleural effusion (regardless of fluid cytology) Evaluable disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 0-2 Hematopoietic: WBC normal Platelet count normal Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) Transaminases no greater than 2 times ULN Alkaline phosphatase no greater than 2 times ULN Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No significant coronary artery disease No documented myocardial infarction No angina, arrhythmia, or congestive heart failure requiring medication Pulmonary: FEV1 greater than 1 liter pO2 greater than 55 mm Hg on room air pCO2 less than 45 mm Hg on room air Other: No prior severe hypersensitivity reaction to products containing Cremaphor EL No clinical evidence of pre-existing polyneuropathy Not pregnant Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior thoracic irradiation Surgery: See Disease Characteristics Other: No concurrent medications known to alter cardiac conduction or cause bradycardia (e.g., digoxin, beta blockers, or calcium channel blockers)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David P. Carbone, MD, PhD
Organizational Affiliation
Vanderbilt-Ingram Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Pennsylvania Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Sarah Cannon-Minnie Pearl Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States

12. IPD Sharing Statement

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Paclitaxel Plus Radiation Therapy in Treating Patients With Untreated Stage III Non-small Cell Lung Cancer

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