Carcinoma, Non-Small-Cell Lung
Conditions
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.
Interventions
DRUGPaclitaxel
On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.
PROCEDURERadiation Therapy
Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible
Sponsors
University of Rochester
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Define the Maximum Tolerated Dose (MTD) Using This Dose Schedule. | 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Survival | 86 months | This is median survival for all subjects enrolled. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Daily RT Plus Chemo on MWF 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
Radiation Therapy : Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible
Paclitaxel : On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am. | 41 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 | 0 | 0 |
| Overall Study | Cancer progression | 2 | 0 | 0 | 1 |
| Overall Study | Death | 0 | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Daily RT Plus Chemo on MWF |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 23 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Age, Continuous | 63.3 years STANDARD_DEVIATION 11.3 |
| Region of Enrollment United States | 41 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 18 |
| serious Total, serious adverse events | 7 / 41 |
Outcome results
Primary
Define the Maximum Tolerated Dose (MTD) Using This Dose Schedule.
Time frame: 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1st Dose Cohort 15mg/m2 Taxol Plus RT | Define the Maximum Tolerated Dose (MTD) Using This Dose Schedule. | 20 Percentage subj w dose limiting toxicity |
| 2nd Dose cohort20 mg/m2 Taxol Plus Daily RT | Define the Maximum Tolerated Dose (MTD) Using This Dose Schedule. | 28.6 Percentage subj w dose limiting toxicity |
| 3rd Dose Cohort --25mg/m2 Taxol Plus RT | Define the Maximum Tolerated Dose (MTD) Using This Dose Schedule. | 33.3 Percentage subj w dose limiting toxicity |
Secondary
Median Survival
This is median survival for all subjects enrolled.
Time frame: 86 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 1st Dose Cohort 15mg/m2 Taxol Plus RT | Median Survival | 10.2 months |