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
  Purpose

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.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: docetaxel
Drug: cisplatin
Procedure: radiation treatment
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of One-Cycle Induction Chemotherapy Followed by Pulsed Docetaxel and Concurrent Radiation for Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Study Start Date: February 2002
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00167401

Locations
United States, New York
University of Rochester, Dept. Radiation Oncology
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Yuhchyau Chen, MD, Ph.D Universtiy of Rochester, Dept of Radiation Oncology
  More Information

No publications provided

Responsible Party: Yuhchyau Chen, MD, Ph.D, University of Rochester, Medical Center
ClinicalTrials.gov Identifier: NCT00167401     History of Changes
Other Study ID Numbers: URCC 1500, Aventis 12083-Chen
Study First Received: September 9, 2005
Last Updated: May 15, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 23, 2014