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NCT00940316 · ClinicalTrials.gov registry record · Phase 2
Dual Epidermal Growth Factor Receptor Inhibition With Erlotinib and Panitumumab With or Without Chemotherapy for Advanced Colorectal Cancer
A Phase 2 study, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
NCT00940316: Completed Phase 2 study, sponsored by Northwestern University.
NCT00940316 is a Phase 2 study that has completed, run by Northwestern University. The registered enrollment target is 28 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00940316, a Phase 2 study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
Study Summary
RATIONALE: Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Panitumumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether erlotinib hydrochloride given together with panitumumab is more effective with or without irinotecan in treating patients with metastatic colorectal cancer. PURPOSE: This randomized phase II trial is studying giving erlotinib hydrochloride together with panitumumab to see how well it works with or without irinotecan hydrochloride as second-line therapy in treating patients with metastatic colorectal cancer.
Primary Outcome
Tumor response rate will be measured by CT scan of the chest and CT scan or MRI scan of abdomen and pelvis every 8 weeks until disease progression response rate will be measured per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions evaluated using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the
Interventions
- DRUG irinotecan hydrochloride
- DRUG erlotinib hydrochloride
- BIOLOGICAL panitumumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2010-01-18 |
| Est. Completion | 2015-01 |
| Phase | Phase 2 |
What the finished NCT00940316 record still lists
NCT00940316 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 3 interventions - of which irinotecan hydrochloride is the first listed.
NCT00940316 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00940316 about?
NCT00940316 is a clinical study titled "Dual Epidermal Growth Factor Receptor Inhibition With Erlotinib and Panitumumab With or Without Chemotherapy for Advanced Colorectal Cancer". RATIONALE: Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and he...
What is the current status of trial NCT00940316?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2010-01-18. Estimated completion is 2015-01.
What interventions are being tested in trial NCT00940316?
The interventions under investigation include: irinotecan hydrochloride (DRUG), erlotinib hydrochloride (DRUG), panitumumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00940316?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00940316's enrollment target sits among peer trials
28 1677th of 2000 higher than 304 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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