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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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Interventions

  • DRUG gemcitabine hydrochloride
  • DRUG erlotinib hydrochloride
  • BIOLOGICAL cixutumumab

Trial Details

FieldValue
Enrollment Target 134 participants
Start Date 2008-03
Est. Completion 2014-02-25
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT00617708

The ClinicalTrials.gov registry entry for NCT00617708 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 134 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which gemcitabine hydrochloride is the first listed.

NCT00617708 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.