Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Simmons Cancer Center |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00547443 |
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Drugs used in chemotherapy, such as carboplatin and 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 sorafenib together with high-dose chemotherapy and external-beam radiation therapy may kill more tumor cells.
PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of sorafenib when given together with high-dose carboplatin, paclitaxel, and external-beam radiation therapy in treating patients with stage III non-small cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: carboplatin Drug: paclitaxel Drug: sorafenib tosylate Radiation: radiation therapy |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | A Randomized Phase I/II Study Of Sorafenib In Combination With High Does Chemoradiation In Patients With Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC) |
Estimated Enrollment: | 84 |
Study Start Date: | July 2007 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm I: Active Comparator
Patients receive chemoradiotherapy comprising paclitaxel, carboplatin, and high-dose external beam radiotherapy (HDRT) as in phase I. Patients also receive consolidation therapy comprising paclitaxel and carboplatin as in phase I.
|
Drug: carboplatin
Given IV
Drug: paclitaxel
Given IV
Radiation: radiation therapy
Given 5 days a week for 7.5 weeks
|
Arm II: Experimental
Patients receive chemoradiotherapy comprising paclitaxel, carboplatin, and HDRT as in phase I. Patients also receive consolidation therapy comprising paclitaxel, carboplatin, and sorafenib tosylate at the MTD as in phase I, as well as maintenance therapy comprising sorafenib tosylate at the MTD as in phase I.
|
Drug: carboplatin
Given IV
Drug: paclitaxel
Given IV
Drug: sorafenib tosylate
Given orally
Radiation: radiation therapy
Given 5 days a week for 7.5 weeks
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Phase I:
Phase II: Patients are randomized to 1 of 2 treatment arms.
Arm I:
Arm II:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Inclusion criteria:
Histologically or cytologically documented non-small cell lung cancer (NSCLC)
Any of the following subtypes allowed:
Tumors adjacent to a vertebral body are allowed as long as all gross disease can be encompassed in the radiation boost field
Pleural effusion that is a transudate, cytologically negative, and nonbloody allowed if the radiation oncologists feel the tumor can still be encompassed within a reasonable field of radiotherapy
Exclusion criteria:
Known brain metastasis
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Cardiac disease including any of the following:
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
Exclusion criteria:
Other concurrent anticancer drugs, including hormonal, immunotherapeutic, or chemotherapeutic agents
United States, Texas | |
Arlington Cancer Center - Arlington | Recruiting |
Arlington, Texas, United States, 76012-2510 | |
Contact: Clinical Trials Office - Arlington Cancer Center - Arlington 817-261-4906 ext. 1443 | |
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Recruiting |
Dallas, Texas, United States, 75390 | |
Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a 866-460-4673; 214-648-7097 |
Study Chair: | Hak Choy, MD | Simmons Cancer Center |
Study ID Numbers: | CDR0000571535, SCCC-052007-068, BAYER-SCCC-052007-068, SCCC-03507 |
Study First Received: | October 19, 2007 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00547443 History of Changes |
Health Authority: | Unspecified |
stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer recurrent non-small cell lung cancer adenocarcinoma of the lung |
squamous cell lung cancer large cell lung cancer bronchoalveolar cell lung cancer adenosquamous cell lung cancer |
Thoracic Neoplasms Adenocarcinoma, Bronchiolo-Alveolar Antimitotic Agents Carboplatin Protein Kinase Inhibitors Recurrence Carcinoma Respiratory Tract Diseases Lung Neoplasms Paclitaxel |
Lung Diseases Tubulin Modulators Non-small Cell Lung Cancer Adenocarcinoma of Lung Adenocarcinoma Antineoplastic Agents, Phytogenic Sorafenib Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Enzyme Inhibitors Antimitotic Agents Carboplatin Protein Kinase Inhibitors Pharmacologic Actions Carcinoma |
Neoplasms Neoplasms by Site Respiratory Tract Diseases Paclitaxel Lung Neoplasms Therapeutic Uses Lung Diseases Tubulin Modulators Antineoplastic Agents, Phytogenic Carcinoma, Non-Small-Cell Lung Sorafenib Neoplasms, Glandular and Epithelial |