Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Ohio State University Comprehensive Cancer Center |
---|---|
Information provided by: | Ohio State University Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT00201825 |
This study will determine the objective response rate in chemotherapy naive non-small cell lung cancer patients with advanced disease.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer Non-Small-Cell Lung Carcinoma |
Drug: Capecitabine Drug: Docetaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | A Phase II Study of Capecitabine and Docetaxel in Previously Untreated Advanced Non-Small Cell Lung Cancer Patients |
Estimated Enrollment: | 39 |
Study Start Date: | December 2004 |
Estimated Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Rationale: Docetaxel has some efficacy against non-small cell lung cancer (NSCLC). This drug is Food and Drug Administration approved in combination with cisplatin (Platinol) for the treatment of unresectable, locally advanced or metastatic NSCLC in patients who have not previously had chemotherapy for this condition. Docetaxel is also approved for second line treatment of metastatic NSCLC. Research indicates that capecitabine, in combination with docetaxel, has efficacy against NSCLC. Capecitabine appears to have anti-cancer activity through several enzymes. This drug is metabolized in the body to another agent called 5-FU. During this conversion process, 5-FU requires thymidine phosphorylase (TP), a cellular characteristic associated with tumor growth. There are higher levels of TP expression in tumors as compared to normal tissue. The drug administration schedule in this study is designed to optimize efficacy against the TP target through both docetaxel and capecitabine. This study will measure biological changes to TP and other enzymes to help researchers gain more information about how capecitabine and docetaxel works against NSCLC.
Purpose: This study will evaluate the efficacy of docetaxel and capecitabine in patients with previously untreated advanced NSCLC. Tests related to tumor biology will be conducted before and during study treatments and correlated with patient responses to therapies.
Treatment: Patients in this study will receive docetaxel and capecitabine. Docetaxel will be administered through intravenous infusions. Capecitabine will be provided through oral pills. A four-week period constitutes one cycle. Docetaxel will be given weekly for three weeks followed by one week of rest. Capecitabine will be taken twice daily on days 5 through 14 of the treatment cycle. Several tests and exams will be given throughout the study to closely monitor patients. Treatments will be discontinued due to disease growth or unacceptable side effects.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contact: Ohio State University Cancer Clinical Trial Matching Service | 866-627-7616 | osu@emergingmed.com |
United States, Ohio | |
Ohio State University | Recruiting |
Columbus, Ohio, United States, 43210 |
Principal Investigator: | Tony Bekaii-Saab | Ohio State University |
Responsible Party: | Ohio State University Comprehensive Cancer Center ( Tony Bekaii-Saab, M.D. ) |
Study ID Numbers: | OSU-0356 |
Study First Received: | September 12, 2005 |
Last Updated: | December 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00201825 |
Health Authority: | United States: Food and Drug Administration |
Previously Untreated Advanced |
Docetaxel Thoracic Neoplasms Capecitabine Non-small cell lung cancer Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Antimetabolites Respiratory Tract Neoplasms Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |