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

Phase 1
18 Years
Not Enrolling
Lung Cancer

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Trial Information

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

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.

Inclusion 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

David P. Carbone, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center


United States: Federal Government

Study ID:




Start Date:

January 1997

Completion Date:

January 2000

Related Keywords:

  • Lung Cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
Sarah Cannon-Minnie Pearl Cancer Center Nashville, Tennessee  37203
Vanderbilt Cancer Center Nashville, Tennessee  37232-6838