Once Weekly Radiation for Lung Cancer With Chemotherapy
| Status: | Completed |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/1/2014 |
| Start Date: | September 2002 |
| End Date: | November 2007 |
| Contact: | Judy Motlow |
| Email: | JOM56@aol.com |
| Phone: | 251 5435 4458 |
Combination of Weekly Radiation and Docetaxel for Locally Advanced Non Small Cell Lung Cancer: A Feasibility Study
This program is designed for the treatment of patients with advanced non-small cell lung
cancer. The study is designed for patients whose cancer is too advanced and therefore
cannot be operated with the goal of completely removing the cancer. Patients at this stage
of their disease traditionally receive radiation therapy or chemotherapy or both treatments
in succession. Recently, the administration of both methods of treatment has been employed
and preliminary studies indicate somewhat better results. Specifically, a new class of
chemotherapy agents called taxanes used in combination with radiation therapy appear
promising as determined in small studies. However, the best treatment for this type of
cancer has not been established yet. One goal of this study is to investigate if the
combination of the new drug Taxotere (a drug belonging to the taxane class) given on the day
of the radiation is well tolerated and will result in enhanced shrinkage of the cancer
compared to traditional radiation therapy. In this study the radiation will be given on one
day, rather than divided over five days per week (Monday through Friday) as in previous
studies. Previous research has shown that both equal in how effective they are in treating
lung cancer. The study will use the drug Taxotere in conjunction with radiation therapy.
Taxotere is an approved medicine by the United States Food and Drug Administration for the
treatment of lung cancer.
The purpose of this study is to evaluate if the chemotherapy drug Taxotere administered once
weekly together with concurrent radiation on the same day is effective in shrinking
non-small cell lung cancer. This trial will also investigate how well this treatment is
tolerated and what effects this treatment will have on the everyday life and activities of
participants.
cancer. The study is designed for patients whose cancer is too advanced and therefore
cannot be operated with the goal of completely removing the cancer. Patients at this stage
of their disease traditionally receive radiation therapy or chemotherapy or both treatments
in succession. Recently, the administration of both methods of treatment has been employed
and preliminary studies indicate somewhat better results. Specifically, a new class of
chemotherapy agents called taxanes used in combination with radiation therapy appear
promising as determined in small studies. However, the best treatment for this type of
cancer has not been established yet. One goal of this study is to investigate if the
combination of the new drug Taxotere (a drug belonging to the taxane class) given on the day
of the radiation is well tolerated and will result in enhanced shrinkage of the cancer
compared to traditional radiation therapy. In this study the radiation will be given on one
day, rather than divided over five days per week (Monday through Friday) as in previous
studies. Previous research has shown that both equal in how effective they are in treating
lung cancer. The study will use the drug Taxotere in conjunction with radiation therapy.
Taxotere is an approved medicine by the United States Food and Drug Administration for the
treatment of lung cancer.
The purpose of this study is to evaluate if the chemotherapy drug Taxotere administered once
weekly together with concurrent radiation on the same day is effective in shrinking
non-small cell lung cancer. This trial will also investigate how well this treatment is
tolerated and what effects this treatment will have on the everyday life and activities of
participants.
40 patients with locally advanced and metastatic NSCLC will be enrolled (stages III and IV)
and treated once per week for a total of 12 cycles (12 weeks) according to the schedule
outlined below.
Chemotherapy: The suggested phase II dose for weekly Taxotere with concomitant standard
chest radiotherapy was determined to be 20mg/m2. In our unpublished phase I clinical trial,
we found 35 mg/m2 to be well tolerated and therefore this dose is chosen for this phase II
study. The drug will be administered intravenously on the same day as the radiation. All
patients will be premedicated 12 hours prior to chemotherapy with Decadrone. Patients will
be followed and evaluated weekly by a physician.
Radiation therapy: Although radiation was delivered differently in previous Taxotere based
combined modality studies, the total radiation dose remains the same. Treatment will be
given to a large field with a 2-3 cm tumor margin. All involved or suspicious nodal areas
will be radiated as well. To reduce volume toxicity, the “field within a field” technique
will be employed. Tumor and involved nodes will receive 200 cGy + 300 cGy. A total of 12
treatments will be administered in weekly, single sessions. Total treatment will be 6000
cGy. Radiation treatment will be administered 24 hours after Taxotere infusion.
and treated once per week for a total of 12 cycles (12 weeks) according to the schedule
outlined below.
Chemotherapy: The suggested phase II dose for weekly Taxotere with concomitant standard
chest radiotherapy was determined to be 20mg/m2. In our unpublished phase I clinical trial,
we found 35 mg/m2 to be well tolerated and therefore this dose is chosen for this phase II
study. The drug will be administered intravenously on the same day as the radiation. All
patients will be premedicated 12 hours prior to chemotherapy with Decadrone. Patients will
be followed and evaluated weekly by a physician.
Radiation therapy: Although radiation was delivered differently in previous Taxotere based
combined modality studies, the total radiation dose remains the same. Treatment will be
given to a large field with a 2-3 cm tumor margin. All involved or suspicious nodal areas
will be radiated as well. To reduce volume toxicity, the “field within a field” technique
will be employed. Tumor and involved nodes will receive 200 cGy + 300 cGy. A total of 12
treatments will be administered in weekly, single sessions. Total treatment will be 6000
cGy. Radiation treatment will be administered 24 hours after Taxotere infusion.
Inclusion Criteria:
1. Patients must have histologic evidence of NSCLC.
2. Should the patient have a history of another malignancy or a second malignancy be
present or discovered, subjects will only be eligible if the NSCLC is determined by
the PI to be the more life-threatening disease and the other malignancy would not
have otherwise a significant impact on the subjects life-expectancy (e.g. basal cell
carcinoma of skin, remote history of early stage breast cancer surgically cured).
3. All patients must have surgically incurable disease, i.e. locally advanced disease
(stage III A or III B) or metastatic stage IV.
4. Performance status of 0 to 2 (ECOG Criteria).
5. Patients should have an absolute granulocyte count > 1500/mm3 and a platelet count >
100,000/mm3.
6. Patients should have adequate hepatic function as indicated by a serum bilirubin <
upper limit of normal (ULN); ALT and AST <2.5 ULN if alkaline phosphatase is < ULN.
Alkaline phosphatase may be up to 4 x ULN if transaminases are < ULN. However,
patients who have both transaminase elevation > 1.5 x ULN and alkaline phosphatase >
2.5 x ULN are not eligible for this study.
7. Patients should have at least a predicted FEV1 of 30%.
8. Patients with active ischemic heart disease (NYHA Class III or IV), congestive heart
failure, symptomatic arrythmias, or a recent history of a myocardial infarction are
excluded.
9. Patients with pre-existing neuropathy (> grade 1) are not eligible for this study.
10. No other serious concurrent medical illness or active infection which would
jeopardize the ability of the patient to receive with reasonable safety the
chemotherapy and surgery program outlined in this protocol is allowed.
11. Signed informed consent: each patient must be aware of the neoplastic nature of
his/her disease and willingly consent to participate in the study after being
informed of the procedure to be followed, the experimental nature of the therapy,
alternatives, potential benefits, side effects, risks, and discomforts.
12. Pregnant women and nursing mothers are ineligible. Women of child-bearing potential
must have a negative pregnancy test. Women of childbearing potential must be willing
to consent to using effective contraception while on treatment and for three months
thereafter.
13. Patients with a history of severe hypersensitivity reaction to TaxotereÒ or other
drugs formulated with polysorbate 80 must be excluded.
14. Patients must be at least 18 years old.
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Exclusion Criteria:
Not falling into the eligibility criteria outlined above
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