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

This study has been completed.
Sponsor:
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00167401
First received: September 9, 2005
Last updated: May 15, 2009
Last verified: May 2009

September 9, 2005
May 15, 2009
February 2002
June 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00167401 on ClinicalTrials.gov Archive Site
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Trial of Chemotherapy Followed by Pulsed Docetaxel and Concurrent Radiation for Non-Small Cell Lung Cancer
A Phase II Trial of One-Cycle Induction Chemotherapy Followed by Pulsed Docetaxel and Concurrent Radiation for Non-Small Cell Lung Cancer

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 treatment for this stage of cancer is chemotherapy (treatment with drugs) combined with radiation (chemo-radiation). Because of the risk of spread to other organs, patients with your stage of disease are also often treated with additional chemotherapy, either before or after the chemo-radiation treatment. The best timing and number of treatments for this additional chemotherapy has not been clearly established. The purpose of this study is to help determine if a single treatment with two chemotherapy drugs, followed by radiation and low-dose chemotherapy is an effective way to treat patients with lung cancer. The side effects of this treatment and your quality of life while on the study will also be studied. Eighteen will participate in this study locally.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Non-Small-Cell Lung
  • Drug: docetaxel
  • Drug: cisplatin
  • Procedure: radiation treatment
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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June 2007   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00167401
URCC 1500, Aventis 12083-Chen
Yes
Yuhchyau Chen, MD, Ph.D, University of Rochester, Medical Center
University of Rochester
Not Provided
Principal Investigator: Yuhchyau Chen, MD, Ph.D Universtiy of Rochester, Dept of Radiation Oncology
University of Rochester
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP