Carcinoma, Non-Small-Cell LungPhase 1/2NCT00178256
Pulsed Paclitaxel And Daily Thoracic Radiotherapy For Inoperable (Stage I/II) Or Unresectable Lung Cancer
A Phase 1/2 study testing Paclitaxel and Radiation Therapy in people with Carcinoma, Non-Small-Cell Lung, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Paclitaxel and Radiation Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 1998to Dec 2012
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester, Dept. Radiation Oncology
Rochester, New York, 14642
About this study
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
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.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Paclitaxel, Radiation Therapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.
Radiation TherapyProcedure or surgery
Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible
| Study group | Role | What they receive |
|---|---|---|
| 1st dose cohort 15mg/m2 taxol plus RT | Experimental | 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 Receives: Drug: Paclitaxel; Procedure: Radiation Therapy |
| 2nd dose cohort20 mg/m2 taxol plus daily RT | Experimental | Not described Receives: Drug: Paclitaxel; Procedure: Radiation Therapy |
| 3rd Dose Cohort --25mg/m2 taxol plus RT | Experimental | Not described Receives: Drug: Paclitaxel; Procedure: Radiation Therapy |
| Phase II Arm --20mg/m2 taxol plus RT | Experimental | Not described Receives: Drug: Paclitaxel; Procedure: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Define the Maximum Tolerated Dose (MTD) Using This Dose Schedule.
Measured: 5 years
Secondary outcomes (1)
Median Survival
This is median survival for all subjects enrolled.
Measured: 86 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJun 1998
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuhchyau Chen, University of Rochester
- Investigators
- Yuhchyau Chen, MD, Ph.D, Principal investigator, Universtiy of Rochester, Dept of Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00178256
- Sponsor's protocol ID
- URCC 1597
- Status last verified
- Aug 2015
- First submitted
- 12 Sep 2005
- Last updated
- 21 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 12631594
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00178256
- Acronym / sponsor ID
- URCC 1597
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Jun 1998
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Posted 30 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1st dose cohort 15mg/m2 taxol plus RT | Experimental | Drug: Paclitaxel, Procedure: Radiation Therapy15 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 | Experimental | Drug: Paclitaxel, Procedure: Radiation Therapy |
| 3rd Dose Cohort --25mg/m2 taxol plus RT | Experimental | Drug: Paclitaxel, Procedure: Radiation Therapy |
| Phase II Arm --20mg/m2 taxol plus RT | Experimental | Drug: Paclitaxel, Procedure: Radiation Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PaclitaxelOn Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am. | Drug | 1st dose cohort 15mg/m2 taxol plus RT, 2nd dose cohort20 mg/m2 taxol plus daily RT, 3rd Dose Cohort --25mg/m2 taxol plus RT, Phase II Arm --20mg/m2 taxol plus RT |
| Radiation TherapyThoracic XRT will be given in late afternoon, after 4:00 PM, if possible | Procedure or surgery | 1st dose cohort 15mg/m2 taxol plus RT, 2nd dose cohort20 mg/m2 taxol plus daily RT, 3rd Dose Cohort --25mg/m2 taxol plus RT, Phase II Arm --20mg/m2 taxol plus RT |
Primary outcome
Define the Maximum Tolerated Dose (MTD) Using This Dose Schedule.
Time frame: 5 years
1 secondary outcome
Median Survival
Time frame: 86 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 12631594Chen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuhchyau Chen, MD, Ph.D principal investigator
Universtiy of Rochester, Dept of Radiation Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Paclitaxel and Radiation Therapy in people with Carcinoma, Non-Small-Cell Lung, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Define the Maximum Tolerated Dose (MTD) Using This Dose Schedule. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00178256, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2015.