Status:
WITHDRAWN
Hypo-Hyperfractionated Chest Radiation for Non Small Cell Lung Cancer With Taxotere/Xeloda Combination Chemotherapy
Lead Sponsor:
Clinical Oncology Research Associates
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
Phase:
PHASE1
PHASE2
Brief Summary
The study is designed for patients with non small cell lung cancer whose cancer is too advanced and therefore cannot be operated with the goal of completely removing the cancer. At this stage of the d...
Detailed Description
The original once weekly hypofractionated chest irradiation protocol descrived by Salazar et al. will be followed with a slight modification. The dose will be split in two fractions, which will be giv...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patients must have histologic evidence of NSCLC. Patients with bronchoalveolar type of NSCLCA are not eligible.
- Should a second malignancy be present or discovered, subjects will only be eligible if the NSCLCA is determined by the PI to be the more life-threatening disease compared to the other malignancy in regards of life-expectancy.
- All patients must have locally advanced disease (stage III A or III B) or metastatic (stage 4). Other stages are not eligible.
- Performance status of 0 -1 (ECOG Criteria).
- Patients should have an absolute granulocyte count \> 1000/mm3 and a platelet count \> 80,000/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 \> 2 x ULN and alkaline phosphatase \> 2.5 x ULN are not eligible for this study.
- Subjects with with severe renal impairment (creatinine clearance below 30 mL/min \[Cockroft and Gault\]) are ineligible.
- 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 medically uncontrollable hypercoagalbility syndromes are not eligible. Patients who are on therapeutic anticoagulation are not excluded.
- Patients with pre-existing serious adverse effects to 5-FU are not eligible for this study. Specifically, subjects with prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil.
- Patients with medical contraindications to Taxanes are not eligible.
- 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.
- Subjects where studies or clinical examination demonstrates lack of physical integrity of the upper gastrointestinal tract, inability to swallow tablets or those who have malabsorption syndrome are not eligible.
- Subjects who have had an organ allograft are not eligible.
- Signed informed consent: each patient must be aware of the neoplastic nature of his/her disease and willingly consent 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. Eligible patients of reproductive age should use contraception. Woman of childbearing potential with either a positive or no pregnancy test at baseline. Woman of childbearing potential not using a reliable and appropriate contraceptive method. (Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential).
- Sexually active males unwilling to practice contraception during the study will not be eligible.
- Patients must be at least 18 years old.
- Known HIV positive patients will not be eligible.
- Patients with prior treatment of Taxotere, Xeloda or 5FU will not be eligible.
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00256841
Start Date
September 1 2005
End Date
October 1 2007
Last Update
January 29 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36607