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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT00178256
First received: September 12, 2005
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: Paclitaxel
Procedure: Radiation Therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Define the Maximum Tolerated Dose (MTD) Using This Dose Schedule. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Median Survival [ Time Frame: 86 months ] [ Designated as safety issue: No ]
    This is median survival for all subjects enrolled.


Enrollment: 41
Study Start Date: June 1998
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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: 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
  More Information

Publications:
Responsible Party: University of Rochester
ClinicalTrials.gov Identifier: NCT00178256     History of Changes
Other Study ID Numbers: URCC 1597
Study First Received: September 12, 2005
Results First Received: December 11, 2013
Last Updated: December 11, 2013
Health Authority: United States: Institutional Review Board

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
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014