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NCT01079780 · ClinicalTrials.gov registry record · Phase 2
Irinotecan Hydrochloride and Cetuximab With or Without Ramucirumab in Treating Patients With Advanced Colorectal Cancer With Progressive Disease After Treatment With Bevacizumab-Containing Chemotherapy
A Phase 2 study of Colorectal Cancer, sponsored by Eastern Cooperative Oncology Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 136
- Enrollment target
- 20
- Study locations
NCT01079780 is a Phase 2 study of Colorectal Cancer that has completed, run by Eastern Cooperative Oncology Group. The registered enrollment target is 136 participants, below the 1,511-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 2 states.
The verdict
NCT01079780, a Phase 2 study of Colorectal Cancer, has completed, sponsored by Eastern Cooperative Oncology Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 136 participants
- Enrollment target
- 20
- Study locations
Study Summary
RATIONALE: 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. Monoclonal antibodies, such as cetuximab and ramucirumab, 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. Cetuximab and ramucirumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. It is not yet know whether giving cetuximab and irinotecan hydrochloride together is more effective with or without ramucirumab in treating colorectal cancer. PURPOSE: This randomized phase II trial is studying the side effects and how well giving cetuximab and irinotecan hydrochloride with or without ramucirumab work in treating patients with advanced colorectal cancer with progressive disease after treatment with bevacizumab-containing chemotherapy.
Conditions Studied
Interventions
- BIOLOGICAL cetuximab
- DRUG irinotecan hydrochloride
- BIOLOGICAL ramucirumab
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
- Poudre Valley Hospital - Fort Collins
- Front Range Cancer Specialists - Fort Collins
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center - Grand Junction
- North Colorado Medical Center - Greeley
- Littleton Adventist Hospital - Littleton
- Sky Ridge Medical Center - Lone Tree
- Hope Cancer Care Center at Longmont United Hospital - Longmont
- McKee Medical Center - Loveland
- Parker Adventist Hospital - Parker
Alabama
- UAB Comprehensive Cancer Center - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2011-01-18 |
| Est. Completion | 2021-08-17 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01079780
The ClinicalTrials.gov registry entry for NCT01079780 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 136 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,511-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (91% lower). The listed sponsor is Eastern Cooperative Oncology Group, which has 141 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Colorectal Cancer appearing as the primary indexed condition, and to 3 interventions - of which cetuximab is the first listed.
NCT01079780 reports 20 study locations spanning 2 distinct geographic areas - top geographies include Colorado, Alabama.
Frequently Asked Questions
What is clinical trial NCT01079780 about?
NCT01079780 is a clinical study titled "Irinotecan Hydrochloride and Cetuximab With or Without Ramucirumab in Treating Patients With Advanced Colorectal Cancer With Progressive Disease After Treatment With Bevacizumab-Containing Chemotherapy". RATIONALE: 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. Monoclonal antibodies, such as cetuximab and ramucirumab, can block tumor growth in different ways. Some b...
What is the current status of trial NCT01079780?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 136 participants. The study started on 2011-01-18. Estimated completion is 2021-08-17.
What conditions does trial NCT01079780 study?
This clinical trial studies the following conditions: Colorectal Cancer.
What interventions are being tested in trial NCT01079780?
The interventions under investigation include: cetuximab (BIOLOGICAL), irinotecan hydrochloride (DRUG), ramucirumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01079780?
This trial is sponsored by Eastern Cooperative Oncology Group, which has 141 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01079780 being conducted?
This trial has 20 study locations across Alabama, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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