Status:
COMPLETED
Combination of Weekly Chest Radiotherapy and Oral Navelbine for the Palliation of Advanced Non Small Cell Lung Cancer: A Phase I Study
Lead Sponsor:
Clinical Oncology Research Associates
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
Phase:
PHASE1
PHASE2
Brief Summary
The study is designed for subjects whose cancer is too advanced and therefore cannot be operated with the goal of completely removing the cancer. At this stage of the disease, most subjects cannot be ...
Detailed Description
35 patients with advanced NSCLC will be enrolled (stages III and IV) and treated once per week in two fractions for a total of 12 cycles using a previous prescription developed by Salazar et al to a t...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Pathologically or cytologically confirmed NSCLC. Histology may include adenocarcinoma, squamous cell, large cell undifferentiated, but no bronchoalveolar carcinoma, small cell or carcinoid.
- Locally advanced NSCLC disease (Stage IIIa or IIIb) or metastatic disease (Stage IV)
- ECOG performance status 0-2 (See Appendix 1 )
- Age \> 18 years.
- Absoloute neutrophil count \> 1500 / mm3 ,platelet count \> 100,000/ mm3
- Serum bilirubin \< upper limit of normal (ULN); ALT and AST \< 2.5 X ULN if alkaline phosphatase is \< ULN. Alkaline phosphatase may be up to 4 X ULN if transaminases are \< ULN.
- Normal serum creatinine (less than 1.5 mg/dl) or creatinine clearance greater than 30 ml/minute (Cockroft and Gault).
- No history of allergy to the agents being used in this study.
- If female of childbearing potential, pregnancy test is negative and must be practicing approved methods of birth control. (Postmenopausal women must have been amenorrheic for at least 12 months to be considered of nonchildbearing potential).
- If fertile, the patient agrees to use acceptable methods to avoid pregnancy for the duration of the study.
- No evidence of CHF, ischemic heart disease (NYHA Class III or IV), or serious arrhythmias or recent history of myocardial infarction.
- No evidence of active infection or serious concurrent medical illness which would jeopardize the ability of the patient to receive with reasonable safety the chemotherapy and radiation program outlined in this protocol.
- 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.
- Patients should have at least a predicted FEV1 of 30%.
- Signed informed consent has been obtained (see the informed consent form Appendix 2). 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.
- B. Exclusion Criteria Patients meeting any of the following criteria will not be eligible for the study.
- Patients with medically uncontrollable hypercoaguability syndromes are not eligible. Patients who are on therapeutic anticoagulation are not excluded.
- Patients with weight loss \> 10% in previous 3 months.
- Patients with prior Vinca Alkaloid treatment.
- Subjects where studies or clinical examination demonstrates lack of physical integrity of the upper gastrointestinal tract (e.g. previous significant surgical resection), inability to swallow capsules intact, dysphagia, or those who have malabsorption syndrome.
- Subjects who have had an organ allograft.
- Patients with known adverse effects to Vinca Alkaloids.
- Subjects with several renal impairment (creatinine clearance below 30ml/min \[Cockroft and Gault\]).
- Pregnant women and nursing mothers.
- Sexually active males unwilling to practice contraception during the study.
Exclusion
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00256815
Start Date
March 1 2003
End Date
September 1 2005
Last Update
February 11 2014
Active Locations (1)
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1
LSUHSC
New Orleans, Louisiana, United States, 70112