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Pulsed Paclitaxel And Daily Thoracic Radiotherapy For Inoperable (Stage I/II) Or Unresectable Lung Cancer

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ClinicalTrials.gov Identifier: NCT00178256
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : January 30, 2014
Last Update Posted : August 21, 2015
Sponsor:
Information provided by (Responsible Party):
Yuhchyau Chen, University of Rochester

Brief Summary:
A treatment study is being conducted by the University of Rochester Cancer Center (URCC) in which patients with non-small cell lung cancer will be treated with radiation therapy and a drug called paclitaxel. Paclitaxel is a natural product with anticancer properties. The first purpose of this study is to determine the dose of paclitaxel which, when given in combination with radiation therapy, will provide the greatest effect have the least side effects. To determine this, patients will be put on the study in groups of 3. The dose for each additional group will be higher than the previous dose until the maximum tolerated dose is reached. The second purpose is to determine if radiation therapy with paclitaxel is more effective in treating lung cancer than radiation therapy alone.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Paclitaxel Procedure: Radiation Therapy Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Clinical Trial Of Pulsed Paclitaxel And Daily Thoracic Radiotherapy For Inoperable (Stage I/II) Or Unresectable (Stage III) Lung Cancers
Study Start Date : June 1998
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1st dose cohort 15mg/m2 taxol plus RT

15 mg/m2 Paclitaxel On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.

On Monday, Tuesday, Wednesday, Thursday, Friday Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible

Drug: Paclitaxel
On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.
Procedure: Radiation Therapy
Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible
Experimental: 2nd dose cohort20 mg/m2 taxol plus daily RT Drug: Paclitaxel
On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.
Procedure: Radiation Therapy
Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible
Experimental: 3rd Dose Cohort --25mg/m2 taxol plus RT Drug: Paclitaxel
On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.
Procedure: Radiation Therapy
Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible
Experimental: Phase II Arm --20mg/m2 taxol plus RT Drug: Paclitaxel
On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.
Procedure: Radiation Therapy
Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible



Primary Outcome Measures :
  1. Define the Maximum Tolerated Dose (MTD) Using This Dose Schedule. [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Median Survival [ Time Frame: 86 months ]
    This is median survival for all subjects enrolled.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed lung cancer, excluding small cell carcinoma
  • Inoperable stage I (T1-2N0) and II (T1-2N1, T3N0) disease, or stage IIIA (T3N1 andT1-3N2M0) and IIIB (TxN3M0, T4NxM0) diseases according to the American Joint Committee of Cancer criteria 1998
  • The primary tumor must be radiographically measurable.
  • Age > 18.
  • Karnofsky performance status > 70.
  • FEV1 sufficient for patients to tolerate radiation therapy which is at the discretion of the radiation oncologist, usually > 800 ml
  • Labs: WBC > 3000; platelet count > 100,000; serum creatinine < 1.5 mg/dl or creatinine clearance >60 ml/min.
  • Laboratory values must be obtained < 3 weeks prior to registration.
  • A signed informed consent.
  • Patients who failed prior chemotherapy are eligible. Patients with prior radiotherapy to the chest region are eligible as long as the normal tissue tolerance is not violated by repeat radiotherapy.

Exclusion Criteria:

  • Patients with medical contraindication to chemotherapy or radiotherapy.
  • Patients with myocardial infarction within the preceding six months or symptomatic heart disease, including uncontrolled or unstable angina, uncontrolled congestive heart failure, and uncontrolled arrhythmia.
  • Women who are pregnant.
  • Patients with small cell carcinoma or mesothelioma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00178256


Locations
United States, New York
University of Rochester, Dept. Radiation Oncology
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Yuhchyau Chen, MD, Ph.D Universtiy of Rochester, Dept of Radiation Oncology

Publications of Results:
Responsible Party: Yuhchyau Chen, Principal Investigator, University of Rochester
ClinicalTrials.gov Identifier: NCT00178256     History of Changes
Other Study ID Numbers: URCC 1597
First Posted: September 15, 2005    Key Record Dates
Results First Posted: January 30, 2014
Last Update Posted: August 21, 2015
Last Verified: August 2015

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