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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: Completed Phase 2 study of Colorectal Cancer, sponsored by Eastern Cooperative Oncology Group.
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 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Progression-fee survival is defined as the time from randomization to disease progression or death without documentation of progression. Censoring occurred at the date of last disease assessment without progression for cases without documentation of progression, except for cases where death occurred within a short period of time (4 months) following the date last known progression-free, in which case the death was considered an event. Progression is defined as appearance of one or more new lesi
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 |
What the finished NCT01079780 record still lists
NCT01079780 is an interventional study that assigns participants to a tested intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (91% lower).
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 names 20 study sites across 2 states, led by 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.
Learn More About Clinical Trials
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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 NCT01079780's enrollment target sits among peer trials
136 183rd of 381 higher than 198 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal 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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