Chemotherapy, Radiotherapy and Bevacizumab in Patients With Unresectable Stage III Non-Small-Cell Lung Cancer
This study has been terminated.
(Terminated due to bevacizumab and chemoradiotherapy toxicity)
Sponsor:
SCRI Development Innovations, LLC
Collaborators:
Genentech, Inc.
Eli Lilly and Company
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00402883
First received: November 21, 2006
Last updated: November 27, 2013
Last verified: November 2013
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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: Radiotherapy Other: Folic Acid Other: vitamin B12 Drug: carboplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Drug Information available for:
Folic acid
Vitamin B Complex
Carboplatin
Pemetrexed
Pemetrexed disodium
Bevacizumab
U.S. FDA Resources
Further study details as provided by SCRI Development Innovations, LLC:
Primary Outcome Measures:
- Time to Progression [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 5 |
| Study Start Date: | November 2006 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Intervention
Induction treatment included: carboplatin AUC=5, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously weeks 1 and 4. Radiation was administered concurrently at a dose of 1.8 Gy/d weeks 1 to 7 to a total of 61.2 Gy per institutional guidelines. Consolidative therapy, following an 8-week break from chemoradiotherapy, included carboplatin AUC=6, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously on week 16, repeated weeks 19 and 22. Folic acid (350 to 1,000 ug or equivalent) supplementation was administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinued study therapy. Vitamin B12(1,000ug) was administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinued therapy.
|
Drug: Bevacizumab
15mg/kg week 1, 4, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, 46, and 49.
Other Name: Avastin
Drug: Pemetrexed
500mg/m2 week 1, 4, 16, 19 and 22.
Other Name: Alimta
Procedure: Radiotherapy
1.8 Gy single daily fractions(Monday-Friday), to total dose 61.2 Gy (7 weeks)
Other Name: RT
Other: Folic Acid
350 to 1,000 ug or equivalent supplementation administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinues study therapy.
Other: vitamin B12
1,000ug administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinues therapy.
Drug: carboplatin
AUC=5 administered intravenously weeks 1 and 4.
|
Detailed Description:
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 pemetrexed 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 pemetrexed 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 |
Criteria
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00402883
Please refer to this study by its ClinicalTrials.gov identifier: NCT00402883
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 | |
Sponsors and Collaborators
SCRI Development Innovations, LLC
Genentech, Inc.
Eli Lilly and Company
Investigators
| Principal Investigator: | David Spigel, MD | SCRI Development Innovations, LLC |
More Information
Additional Information:
Publications:
| Responsible Party: | SCRI Development Innovations, LLC |
| ClinicalTrials.gov Identifier: | NCT00402883 History of Changes |
| Other Study ID Numbers: | SCRI LUN 134 |
| Study First Received: | November 21, 2006 |
| Results First Received: | August 15, 2013 |
| Last Updated: | November 27, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Bevacizumab Carboplatin Pemetrexed |
Angiogenesis Inhibitors Angiogenesis Modulating Agents Antimetabolites Antimetabolites, Antineoplastic Antineoplastic Agents Enzyme Inhibitors Folic Acid Antagonists Growth Inhibitors Growth Substances Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on March 02, 2015