Chemotherapy, Radiotherapy and Bevacizumab in Patients With Unresectable Stage III Non-Small-Cell Lung Cancer
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Purpose
The purpose of this study is to see if this combination of chemotherapy plus radiation therapy and immunotherapy (with bevacizumab) expands treatment options for patients with non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: Bevacizumab Drug: Pemetrexed Procedure: Radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Pemetrexed/Carboplatin/Radiotherapy and Bevacizumab in Patients With Unresectable Stage III Non-Small-Cell Lung Cancer |
- Time to progression [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- To evaluate the objective response rates [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | November 2006 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
-
Drug: Bevacizumab
The patients on this study will receive treatment in 3 stages of therapy.
The first stage is Induction Therapy. This therapy is 7 weeks long. Patients will receive bevacizumab followed by premetrexed followed by carboplatin all by vein once a week in weeks 1 and 4. During Induction patients will also receive radiation therapy daily, Monday through Friday, for 7 weeks (weeks 1-7). This is followed by 2 weeks of rest. During this rest period patients will have scans done to see how their disease has responded to treatment.
The next stage of treatment is Consolidation Therapy. This stage is 10 weeks long. Patients will receive bevacizumab followed by premetrexed followed by carboplatin all by vein once a week in weeks 10, 13 and 16. This is followed by 3 weeks rest. During week 19 patients will have scans to see how their disease has responded to treatment.
The last stage of treatment is maintenance Therapy. Patients will receive bevacizumab alone by vein every 3 weeks. Treatment will be given every three weeks for up to 9 treatments. (week 45)
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Clinically confirmed non-small cell lung cancer stage IIIA and selected stage IIIB
- Measurable or evaluable disease
- Be up and about and able to care for self
- Adequate kidney, liver and bone marrow function
- No prior treatment for this disease
- Must be able to give written informed consent
- Must be able to take folic acid, vitamin B12 and dexamethasone as described in the protocol
- Age 18 years or older
Exclusion Criteria:
- Stage IV or IIIB patients with pleural or pericardial effusions
- Stage IIIB disease with contralateral mediastinal nodes greater than 4cm
- Squamous cell predominant tumors
- Pregnant or lactating women
- Patients with active infections
- History of another cancer within the last 5 years with the exception of skin cancer or cervical carcinoma in situ
- History of stroke, transient ischemic attacks, or acute MI within the past 6 months or any other serious cardiovascular disease
- Symptoms of peripheral vascular disease
- History of neurological disease
- Recent history of blood in the sputum or vomitus
- Non-healing wounds, ulcer or long bone fractures
- History of bleeding problems or coagulation problems
- History of abdominal fistula, gastrointestinal perforation or intraabdominal abscess within 6 months
- History of uncontrolled hypertension
- Chronic use of non-steroidal anti-inflammatory medication not allowed on this study
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.
Contacts and Locations| United States, Florida | |
| Gainsville Hematology Oncology Associates | |
| Gainesville, Florida, United States, 32605 | |
| Watson Clinic Center for Cancer Care and Research | |
| Lakeland, Florida, United States, 33805 | |
| United States, Georgia | |
| Wellstar Cancer Research | |
| Marietta, Georgia, United States, 30060 | |
| United States, Kentucky | |
| Consultants in Blood Disorders and Cancer | |
| Louisville, Kentucky, United States, 40207 | |
| United States, Ohio | |
| Oncology Hematology Care | |
| Cincinnati, Ohio, United States, 45242 | |
| United States, Tennessee | |
| Associates in Hematology Oncology | |
| Chattanooga, Tennessee, United States, 37404 | |
| Tennessee Oncology, PLLC | |
| Nashville, Tennessee, United States, 37023 | |
| Principal Investigator: | David Spigel, MD | Sarah Cannon Research Institute |
More Information
Additional Information:
Publications:
| Responsible Party: | David Spigel, M.D., SCRI Oncology Research Consortium |
| ClinicalTrials.gov Identifier: | NCT00402883 History of Changes |
| Other Study ID Numbers: | SCRI LUN 134, AVF3793s, H3E-US-1019 |
| Study First Received: | November 21, 2006 |
| Last Updated: | May 3, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Pemetrexed Bevacizumab Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Antimetabolites, Antineoplastic Antimetabolites Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013