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NCT00454194 · ClinicalTrials.gov registry record · Phase 2
Pemetrexed Disodium With or Without Sorafenib as Second-Line Therapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
A Phase 2 study of Lung Cancer, sponsored by Alliance for Clinical Trials in Oncology.
- Completed
- Registry status
- Phase 2
- Development phase
- 110
- Enrollment target
- 20
- Study locations
NCT00454194: Completed Phase 2 study of Lung Cancer, sponsored by Alliance for Clinical Trials in Oncology.
NCT00454194 is a Phase 2 study of Lung Cancer that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 110 participants, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00454194, a Phase 2 study of Lung Cancer, has completed, sponsored by Alliance for Clinical Trials in Oncology.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 110 participants
- Enrollment target
- 20
- Study locations
Study Summary
RATIONALE: Pemetrexed disodium and sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving pemetrexed disodium together with sorafenib may kill more tumor cells. PURPOSE: This randomized phase II trial is studying pemetrexed disodium and sorafenib to see how well they work compared with pemetrexed disodium alone as second-line therapy in treating patients with stage IIIB or stage IV non-small cell lung cancer.
Primary Outcome
The progression-free survival (PFS) was defined as the time from date of randomization to the documentation of disease progression or death as a result of any cause, whichever comes first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Conditions Studied
Interventions
- DRUG pemetrexed disodium
- DRUG sorafenib tosylate
Study Locations (20)
Colorado
- Aurora Presbyterian Hospital - Aurora
- Boulder Community Hospital - Boulder
- Penrose Cancer Center at Penrose Hospital - Colorado Springs
- St. Anthony Central Hospital - Denver
- Porter Adventist Hospital - Denver
- Presbyterian - St. Luke's Medical Center - Denver
- St. Joseph Hospital - Denver
- Rose Medical Center - Denver
- CCOP - Colorado Cancer Research Program - Denver
- Swedish Medical Center - Englewood
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center - Grand Junction
- North Colorado Medical Center - Greeley
- Sky Ridge Medical Center - Lone Tree
- Hope Cancer Care Center at Longmont United Hospital - Longmont
- McKee Medical Center - Loveland
- St. Mary - Corwin Regional Medical Center - Pueblo
- North Suburban Medical Center - Thornton
- Exempla Lutheran Medical Center - Wheat Ridge
Arizona
- Mayo Clinic Scottsdale - Scottsdale
Florida
- Mayo Clinic - Jacksonville - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2007-09 |
| Est. Completion | 2013-05 |
| Phase | Phase 2 |
What the finished NCT00454194 record still lists
NCT00454194 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which pemetrexed disodium is the first listed.
NCT00454194 names 20 study sites across 3 states, led by Colorado, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT00454194 about?
NCT00454194 is a clinical study titled "Pemetrexed Disodium With or Without Sorafenib as Second-Line Therapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer". RATIONALE: Pemetrexed disodium and sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving pemetrexed disodium together with sorafenib may kill more tumor cells....
What is the current status of trial NCT00454194?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 110 participants. The study started on 2007-09. Estimated completion is 2013-05.
What conditions does trial NCT00454194 study?
This clinical trial studies the following conditions: Lung Cancer.
What interventions are being tested in trial NCT00454194?
The interventions under investigation include: pemetrexed disodium (DRUG), sorafenib tosylate (DRUG).
Who is sponsoring clinical trial NCT00454194?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00454194 being conducted?
This trial has 20 study locations across Arizona, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Lung Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00454194's enrollment target sits among peer trials
110 178th of 409 higher than 231 of 409 other Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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