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Therapeutic Areas: Oncology | Pulmonary/Respiratory Diseases | Family Medicine
Disease Category: Lung Cancer
Location: United States, IL

Clinical Trial Details

Overview

Research Study Summary

S0709 - Phase II A Phase II Selection Design of Pharmacodynamic Separation of Carboplatin/Paclitaxel/OSI-774 (Erlotinib; NSC-718781) or OSI-774 Alone in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients with Performance Status 2 (PS-2) Selected by Serum Proteomics

Purpose

The purpose of this study is to find out whether a pill, OSI-774 (erlotinib), with or without chemotherapy (carboplatin and paclitaxel) would be effective in controlling your lung cancer by either shrinking the tumor or preventing it from growing. This study will look into the effects of the planned therapy on your cancer if you have a certain level of a protein called epidermal growth factor receptor (EGFR).

This research is being done because people who are impaired to the point that they are unable to work due to their lung cancer, but who are up and about at least half the time, have a difficult time receiving and completing treatment for lung cancer. We would like to find treatment which could be better for these people.

The study also finds out what effects (good and bad) the treatment has on you and your lung cancer.

Patient Inclusion Criteria:

  • Patients must have histologically or cytologically proven newly diagnosed selected Stage IIIB (T4 lesion due to malignant pleural effusion) or Stage IV, as defined in Section 4.0, advanced primary non-small cell lung cancer (adenocarcinoma, large cell carcinoma, squamous cell carcinoma or unspecified) or recurrent disease after previous surgery and/or irradiation
  • Patients must have measurable or non-measurable disease documented by CT, MRI, X-ray, physical exam or nuclear exam. Measurable disease must be assessed within 28 days prior to registration. Non-measurable disease must be assessed within 42 days prior to registration
  • Patients must have a Zubrod Performance Status of 2
  • Patients may have received prior radiation therapy provided that at least 14 days have elapsed since the completion of prior radiation therapy and patients have recovered from all associated toxicities at the time of registration
  • Patients may have received prior surgery provided that at least 21 days have elapsed since surgery (thoracic or other major surgeries) and patients have recovered from all associated toxicities at the time of registration. There must be no anticipation of need for major surgical procedures during protocol treatment

Patient Exclusion Criteria:

  • Patients with untreated brain metastases are ineligible
  • All patients with neurologic abnormalities on physical examination or symptoms must have a negative pretreatment

To Learn more
Phase

2

Gender

Both Male and Female

Age

N/A

Overall Status

Recruiting

Facility Type

N/A

Contact

Janeen V. Bazan, RN OCN BSN CCRP, Oncology Research Nurse Program Coordinator
Sherman Health
1425 North Randall Road
Elgin, IL 60123
Phone: 224-783-2907
Fax: 224-783-3071

View Map

Research Center Information: Sherman Health

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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CW ID: 183149

Date Last Changed: July 17, 2013


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