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NCT01213238 · ClinicalTrials.gov registry record · Phase 1
Hepatic Arterial Infusion Oxaliplatin, Capecitabine With or Without Bevacizumab
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 116
- Enrollment target
NCT01213238: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT01213238 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 116 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01213238, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 116 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to find the highest tolerable dose of the combination of oxaliplatin and capecitabine with or without bevacizumab that can be given to patients with advanced cancer that has spread to the liver. The safety of these drug combinations will also be studied.
Primary Outcome
If more than 33% of patients enrolled in any particular dose level develop dose limiting toxicity (DLT), treatment will continue at dose level immediately below. If not more than 33% of the patients in cohort develop DLT, this cohort considered MTD. DLT defined as any grade 3 or 4 non-hematologic toxicity as defined in current version of NCI CTCAE, even if related to study medications (except nausea and vomiting, electrolyte imbalances responsive to appropriate regimens or alopecia), any grade 4
Interventions
- DRUG Bevacizumab
- DRUG Capecitabine
- DRUG Oxaliplatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2010-09-30 |
| Est. Completion | 2018-09-26 |
| Phase | Phase 1 |
What the finished NCT01213238 record still lists
NCT01213238 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% higher).
The record links to 0 conditions, and to 3 interventions - of which Bevacizumab is the first listed.
NCT01213238 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01213238 about?
NCT01213238 is a clinical study titled "Hepatic Arterial Infusion Oxaliplatin, Capecitabine With or Without Bevacizumab". The goal of this clinical research study is to find the highest tolerable dose of the combination of oxaliplatin and capecitabine with or without bevacizumab that can be given to patients with advanced cancer that has spread to the liver. The safety of these drug combinations will also be studied.
What is the current status of trial NCT01213238?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 116 participants. The study started on 2010-09-30. Estimated completion is 2018-09-26.
What interventions are being tested in trial NCT01213238?
The interventions under investigation include: Bevacizumab (DRUG), Capecitabine (DRUG), Oxaliplatin (DRUG).
Who is sponsoring clinical trial NCT01213238?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01213238's enrollment target sits among peer trials
116 501st of 2000 higher than 1,497 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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