Pulsed Paclitaxel And Daily Thoracic Radiotherapy For Inoperable (Stage I/II) Or Unresectable Lung Cancer
A Phase I/II Clinical Trial Of Pulsed Paclitaxel And Daily Thoracic Radiotherapy For Inoperable (Stage I/II) Or Unresectable (Stage III) Lung Cancers
1 other identifier
interventional
41
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 1998
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 1998
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
January 30, 2014
CompletedAugust 21, 2015
August 1, 2015
14.5 years
September 12, 2005
December 11, 2013
August 3, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Define the Maximum Tolerated Dose (MTD) Using This Dose Schedule.
5 years
Secondary Outcomes (1)
Median Survival
86 months
Study Arms (4)
1st dose cohort 15mg/m2 taxol plus RT
EXPERIMENTAL15 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
2nd dose cohort20 mg/m2 taxol plus daily RT
EXPERIMENTAL3rd Dose Cohort --25mg/m2 taxol plus RT
EXPERIMENTALPhase II Arm --20mg/m2 taxol plus RT
EXPERIMENTALInterventions
On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.
Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Rochester, Dept. Radiation Oncology
Rochester, New York, 14642, United States
Related Publications (1)
Chen Y, Pandya K, Keng PC, Johnstone D, Li J, Lee YJ, Smudzin T, Okunieff P. Phase I/II clinical study of pulsed paclitaxel radiosensitization for thoracic malignancy: a therapeutic approach on the basis of preclinical research of human cancer cell lines. Clin Cancer Res. 2003 Mar;9(3):969-75.
PMID: 12631594RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Yuhchyau Chen MD, PhD
- Organization
- University of Rochester
Study Officials
- PRINCIPAL INVESTIGATOR
Yuhchyau Chen, MD, Ph.D
Universtiy of Rochester, Dept of Radiation Oncology
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 15, 2005
Study Start
June 1, 1998
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
August 21, 2015
Results First Posted
January 30, 2014
Record last verified: 2015-08