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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002519
First received: November 1, 1999
Last updated: May 1, 2013
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: chemotherapy
Drug: paclitaxel
Radiation: radiation therapy
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: PH I Continuous Infusion Taxol in Combination With Thoracic Radiation Therapy in Untreated Locally Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Enrollment: 6
Study Start Date: January 1997
Study Completion Date: January 2000
Primary Completion Date: January 2000 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002519

Locations
United States, Pennsylvania
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Sarah Cannon-Minnie Pearl Cancer Center
Nashville, Tennessee, United States, 37203
Vanderbilt Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Study Chair: David P. Carbone, MD, PhD Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: David Carbone, M.D., Ph.D., Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00002519     History of Changes
Other Study ID Numbers: VCC LUN65, P30CA068485, VU-VCC-LUN-65, UPCC-3597, NCI-T92-0246D
Study First Received: November 1, 1999
Last Updated: May 1, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 25, 2014