Chemotherapy, Radiotherapy and Bevacizumab in Patients With Unresectable Stage III Non-Small-Cell Lung Cancer
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| ClinicalTrials.gov Identifier: NCT00402883 |
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Recruitment Status :
Terminated
(Terminated due to bevacizumab and chemoradiotherapy toxicity)
First Posted : November 22, 2006
Results First Posted : January 13, 2014
Last Update Posted : January 13, 2014
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Sponsor:
SCRI Development Innovations, LLC
Collaborators:
Genentech, Inc.
Eli Lilly and Company
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Lung Cancer |
| Interventions |
Drug: Bevacizumab Drug: Pemetrexed Procedure: Radiotherapy Other: Folic Acid Other: vitamin B12 Drug: carboplatin |
| Enrollment | 5 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | Pemetrexed/Carboplatin/Radiotherapy and Bevacizumab |
|---|---|
 Arm/Group Description |
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. |
| Period Title: Induction Therapy | |
| Started | 5 |
| Completed | 5 |
| Not Completed | 0 |
| Period Title: Consolidation Therapy | |
| Started | 5 |
| Completed | 5 |
| Not Completed | 0 |
| Period Title: Maintenance Therapy | |
| Started | 5 |
| Completed | 5 [1] |
| Not Completed | 0 |
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[1]
All 5 patients received limited maintenance therapy due to early trial closure.
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Baseline Characteristics
| Arm/Group Title | Pemetrexed/Carboplatin/Radiotherapy and Bevacizumab | |
|---|---|---|
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Arm/Group Description |
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. | |
| Overall Number of Baseline Participants | 5 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 5 participants | |
| <=18 years |
0 0.0%
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| Between 18 and 65 years |
3 60.0%
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| >=65 years |
2 40.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 5 participants | |
| 64.6 (8.9) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 5 participants | |
| Female |
2 40.0%
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| Male |
3 60.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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| United States | Number Analyzed | 5 participants |
| 5 | ||
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The sponsor can review/embargo results communications prior to public release for a period that is >60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
Results Point of Contact
| Name/Title: | John Hainsworth, MD |
| Organization: | Sarah Cannon Research Institute |
| Phone: | 1-877-691-7274 |
| EMail: | asksarah@scresearch.net |
| Responsible Party: | SCRI Development Innovations, LLC |
| ClinicalTrials.gov Identifier: | NCT00402883 |
| Other Study ID Numbers: |
SCRI LUN 134 |
| First Submitted: | November 21, 2006 |
| First Posted: | November 22, 2006 |
| Results First Submitted: | August 15, 2013 |
| Results First Posted: | January 13, 2014 |
| Last Update Posted: | January 13, 2014 |