Trial of Chemotherapy Followed by Pulsed Docetaxel and Concurrent Radiation for Non-Small Cell Lung Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00167401
• Date of registration: 09/09/2005
• Primary sponsor: University of Rochester
• Public title: Trial of Chemotherapy Followed by Pulsed Docetaxel and Concurrent Radiation for Non-Small Cell Lung Cancer
• Scientific title: A Phase II Trial of One-Cycle Induction Chemotherapy Followed by Pulsed Docetaxel and Concurrent Radiation for Non-Small Cell Lung Cancer
• Date of first enrolment: February 2002
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00167401
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Yuhchyau Chen, MD, Ph.D
• Affiliation: Universtiy of Rochester, Dept of Radiation Oncology

Key inclusion & exclusion criteria

Inclusion Criteria:

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 Criteria:

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Carcinoma, Non-Small-Cell Lung

Intervention(s)

Drug: cisplatin

Drug: docetaxel

Procedure: radiation treatment

Secondary ID(s)

Aventis 12083-Chen

URCC 1500

Source(s) of Monetary Support

Please refer to primary and secondary sponsors