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| Sponsor: | Fred Hutchinson Cancer Research Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00662311 |
Purpose
RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving vorinostat together with paclitaxel and radiation therapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of vorinostat and to see how well it works when given together with paclitaxel and radiation therapy in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: paclitaxel Drug: vorinostat Radiation: radiation therapy |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label |
| Official Title: | Phase I/II Clinical Trial Evaluating the Use of Vorinostat Combined With Paclitaxel and Radiotherapy in Patients With Inoperable Stage III Non-Small Cell Lung Cancer Unable to Tolerate Cisplatin |
| Estimated Enrollment: | 35 |
| Study Start Date: | March 2008 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a phase I, dose-escalation study of vorinostat followed by a phase II study.
Patients receive paclitaxel IV over 1 hour once weekly and oral vorinostat once daily in weeks 1-7. Patients also undergo thoracic radiotherapy once daily, 5 days a week in weeks 1-7. Treatment continues in the absence of progressive disease or unacceptable toxicity.
After completion of study therapy, patients are followed at 30 days, 12 weeks, every 3 months for 2 years, and then every 6 months for 1 year.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
Unable to tolerate full-dose cisplatin as defined by 1 of the following criteria:
PATIENT CHARACTERISTICS:
No "currently active" second malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, Washington | |
| Fred Hutchinson Cancer Research Center | Recruiting |
| Seattle, Washington, United States, 98109-1024 | |
| Contact: Patel Shilpen, MD 206-667-4692 | |
| Seattle Cancer Care Alliance | Recruiting |
| Seattle, Washington, United States, 98109-1023 | |
| Contact: Clinical Trials Office - Seattle Cancer Care Alliance 800-804-8824 | |
| Principal Investigator: | Patel Shilpen, MD | University of Washington |
More Information
| Responsible Party: | Fred Hutchinson Cancer Research Center ( Patel Shilpen ) |
| Study ID Numbers: | CDR0000594175, UWCC-6600, MERCK-UWCC-6600, UWCC-UW 6600, UWCC-08-0469-H/A |
| Study First Received: | April 18, 2008 |
| Last Updated: | July 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00662311 History of Changes |
| Health Authority: | Unspecified |
|
stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer |
|
Anticarcinogenic Agents Anti-Inflammatory Agents Thoracic Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Respiratory Tract Neoplasms Neoplasms by Histologic Type |
Vorinostat Mitosis Modulators Enzyme Inhibitors Antimitotic Agents Protective Agents Pharmacologic Actions Carcinoma Neoplasms Paclitaxel Analgesics, Non-Narcotic Lung Diseases Tubulin Modulators Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |