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NCT00617708 · ClinicalTrials.gov registry record · Phase 1
S0727 Gemcitabine Hydrochloride and Erlotinib Hydrochloride With or Without Monoclonal Antibody Therapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 134
- Enrollment target
NCT00617708: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00617708 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 134 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (123% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00617708, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 134 participants
- Enrollment target
Study Summary
This randomized phase I/II trial is studying the side effects and best dose of monoclonal antibody therapy when given together with gemcitabine hydrochloride and erlotinib hydrochloride and to see how well they work compared with giving gemcitabine hydrochloride and erlotinib hydrochloride alone as first-line therapy in treating patients with metastatic pancreatic cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies 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. Giving erlotinib hydrochloride and gemcitabine hydrochloride together with monoclonal antibody therapy may kill more tumor cells.
Primary Outcome
Maximum dose of IMC-A12 (in combination with erlotinib and gemcitabine) at which 3/10 or fewer patients have dose-limiting toxicities (DLT). Toxicities graded according to the NCI Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0). DLT apply only during cycle 1 and should be drug-related (possible, probable, or definite).
Interventions
- DRUG gemcitabine hydrochloride
- DRUG erlotinib hydrochloride
- BIOLOGICAL cixutumumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2008-03 |
| Est. Completion | 2014-02-25 |
| Phase | Phase 1 |
What the finished NCT00617708 record still lists
NCT00617708 is an interventional study that assigns participants to a tested intervention. The registered 134 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 (123% higher).
The record links to 0 conditions, and to 3 interventions - of which gemcitabine hydrochloride is the first listed.
NCT00617708 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00617708 about?
NCT00617708 is a clinical study titled "S0727 Gemcitabine Hydrochloride and Erlotinib Hydrochloride With or Without Monoclonal Antibody Therapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery". This randomized phase I/II trial is studying the side effects and best dose of monoclonal antibody therapy when given together with gemcitabine hydrochloride and erlotinib hydrochloride and to see how well they work compared with giving gemcitabine hydrochloride and erlotinib hydrochloride alone as ...
What is the current status of trial NCT00617708?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 134 participants. The study started on 2008-03. Estimated completion is 2014-02-25.
What interventions are being tested in trial NCT00617708?
The interventions under investigation include: gemcitabine hydrochloride (DRUG), erlotinib hydrochloride (DRUG), cixutumumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00617708?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00617708's enrollment target sits among peer trials
134 427th of 2000 higher than 1,569 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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