Status:
COMPLETED
Once Weekly Radiation for Lung Cancer With Chemotherapy
Lead Sponsor:
Clinical Oncology Research Associates
Collaborating Sponsors:
Aventis Pharmaceuticals
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
Phase:
NA
Brief Summary
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 t...
Detailed Description
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. Che...
Eligibility Criteria
Inclusion
- Patients must have histologic evidence of NSCLC.
- 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).
- All patients must have surgically incurable disease, i.e. locally advanced disease (stage III A or III B) or metastatic stage IV.
- Performance status of 0 to 2 (ECOG Criteria).
- Patients should have an absolute granulocyte count \> 1500/mm3 and a platelet count \> 100,000/mm3.
- 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.
- Patients should have at least a predicted FEV1 of 30%.
- 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.
- Patients with pre-existing neuropathy (\> grade 1) are not eligible for this study.
- 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.
- 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.
- 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.
- Patients with a history of severe hypersensitivity reaction to TaxotereÒ or other drugs formulated with polysorbate 80 must be excluded.
- Patients must be at least 18 years old.
- \-
Exclusion
- Not falling into the eligibility criteria outlined above
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2004
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00256789
Start Date
September 1 2002
End Date
December 1 2004
Last Update
February 11 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cancer Center and Mobile Infirmary Hospital
Mobile, Alabama, United States, 36607