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

Lung Cancer Clinical Trial

Official title:

PH I Continuous Infusion Taxol in Combination With Thoracic Radiation Therapy in Untreated Locally Advanced Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002519
• Other study ID #: VCC LUN65
• Secondary ID: P30CA068485VU-VC
• Status: Completed
• Phase: Phase 1
• First received: November 1, 1999
• Last updated: May 1, 2013
• Start date: January 1997
• Est. completion date: January 2000

Study information

• Verified date: April 2011
• Source: National Cancer Institute (NCI)
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: January 2000
• Est. primary completion date: January 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• chemotherapy

• paclitaxel

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	Sarah Cannon-Minnie Pearl Cancer Center	Nashville	Tennessee
United States	Vanderbilt Cancer Center	Nashville	Tennessee
United States	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,