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NCT00005926 · ClinicalTrials.gov registry record · Phase 2
Gemcitabine, Herceptin and Radiation to Treat Cancer of the Pancreas
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT00005926: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00005926 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 50 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00005926, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
This study will examine the safety and effectiveness of the drugs Gemcitabine and Herceptin, given in conjunction with radiation therapy, for treating patients with cancer of the pancreas. Gemcitabine is standard therapy for advanced pancreatic cancer. It damages tumor cells and may enhance the effects of radiation therapy. Herceptin is a genetically engineered antibody that has prevented some tumors from growing in patients with breast cancer. Because breast and pancreatic cancer cells share an characteristic related to how Herceptin works (similar HER-2/neu receptor proteins), it is thought that this drug may also inhibit growth of tumors of the pancreas. Patients with pancreatic cancer may be eligible for this study. Candidates will be screened with a physical examination, chest X-ray, blood tests, electrocardiogram, and computerized tomography (CT) scan of the chest, abdomen and pelvis. They will also have a minor surgical procedure called a laparoscopy to evaluate the extent of their cancer. This procedure, done under general anesthesia, requires an overnight hospital stay. A small incision (about 1 inch) is made in the abdomen and a thin, flexible tube with a light and special fibers at the end is inserted into the opening. This device, called a laparoscope, allows the surgeon to see inside the abdominal cavity to evaluate the tumor and also to remove a small piece of tumor tissue for examination. Patients accepted into the study will be assigned to one of two treatment groups, according to whether or not their tumor can be removed with surgery. Patients will be asked to complete a Quality of Life Evaluation before treatment begins and again at each follow-up visit. This 15-minute questionnaire assesses patients' feelings, their ability to carry out usual activities, and the effects of therapy on their general health and well being. Patients in both treatment groups will be given the same chemotherapy, on an outpatient basis unless special circumstances req
Interventions
- DRUG Gemcitabine
- DRUG Herceptin
- PROCEDURE Radiation therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2000-06 |
| Est. Completion | 2000-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00005926
The ClinicalTrials.gov registry entry for NCT00005926 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 50 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 is the first listed.
NCT00005926 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00005926 about?
NCT00005926 is a clinical study titled "Gemcitabine, Herceptin and Radiation to Treat Cancer of the Pancreas". This study will examine the safety and effectiveness of the drugs Gemcitabine and Herceptin, given in conjunction with radiation therapy, for treating patients with cancer of the pancreas. Gemcitabine is standard therapy for advanced pancreatic cancer. It damages tumor cells and may enhance the effe...
What is the current status of trial NCT00005926?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2000-06. Estimated completion is 2000-12.
What interventions are being tested in trial NCT00005926?
The interventions under investigation include: Gemcitabine (DRUG), Herceptin (DRUG), Radiation therapy (PROCEDURE).
Who is sponsoring clinical trial NCT00005926?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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