Status:
COMPLETED
Trial of Chemotherapy Followed by Pulsed Docetaxel and Concurrent Radiation for Non-Small Cell Lung Cancer
Lead Sponsor:
University of Rochester
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The University of Rochester Cancer Center (URCC) is conducting a research study at Highland Hospital and Strong Memorial of lung cancer patients whose tumors cannot be surgically removed. The usual tr...
Eligibility Criteria
Inclusion
- Histologically confirmed non-small cell lung cancer.
- Clinical or pathologic stage IIIA (T1-3N2M0, T3N1M0) and IIIB (Any T N3M0, T4 Any N M0) diseases according to the American Joint Committee of Cancer criteria (Appendix I). Patients with malignant pleural effusion will be excluded.
- The primary tumor must be radiographically measurable with bi-dimensionally measurable disease
- Age \> 18.
- Karnofsky performance status \> 70 (Appendix II).
- FEV1 sufficient for patients to tolerate radiation therapy, which is at the discretion of the radiation oncologist, usually \> 800 ml, but may be higher or lower depending on the volume of radiotherapy portal, which is a variable of the tumor extent.
- WBC \> 3000; platelet count \> 100,000; absolute neutrophil counts \> 1,000; hemoglobin ≥ 8.0 g/dl; serum creatinine \< 1.5 mg/dl or creatinine clearance \>60 ml/min. Laboratory values must be obtained \< 3 weeks prior to registration.
- Patients with equivocal enlargement of adrenal gland(s) on CT scan, or a few equivocal regional or distant lesions on any imaging studies need further imaging study or biopsy to rule out distant metastasis.
- Transaminases (SGOT and/or SGPT) may be up to 2.5 x institutional upper limit of normal (ULN) if alkaline phosphatase is \< ULN, or 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 (due to decreased clearance of docetaxel and increased risk of toxicity).
- Pre-existing neuropathy must be grade I or less.
- A signed informed consent.
- Women of childbearing potential must have a negative pregnancy test.
- Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter.
Exclusion
- Patients with distant metastasis (stage IV disease).
- Patients without measurable disease.
- Patients with medical contraindication to chemotherapy or radiotherapy.
- Patients with myocardial infarction within the preceding six months or symptomatic heart disease, including angina, congestive heart failure, uncontrolled arrhythmia.
- Patients with bilirubin elevated above institutional upper limit of normal (ULN) must be excluded.
- Women who are pregnant or breast feeding are not eligible.
- Patients with a history of severe hypersensitivity reaction to Taxotere® or other drugs formulated with polysorbate 80 must be excluded.
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00167401
Start Date
February 1 2002
Last Update
May 19 2009
Active Locations (1)
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1
University of Rochester, Dept. Radiation Oncology
Rochester, New York, United States, 14642