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NCT01130519 · ClinicalTrials.gov registry record · Phase 2
A Phase II Study of Bevacizumab and Erlotinib in Subjects With Advanced Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) or Sporadic Papillary Renal Cell Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 83
- Enrollment target
NCT01130519: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01130519 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 83 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01130519, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 83 participants
- Enrollment target
Study Summary
Background: * At the present time, there are no drugs that have been proven to work in patients with papillary kidney cancer that has spread (metastasized) beyond the kidneys. Researchers are interested in determining whether the combination of the drugs bevacizumab and erlotinib can be used to treat metastatic papillary kidney cancer. * Hereditary Leiomyomatosis and Renal Cell Carcinoma (HLRCC) is an inherited type of papillary kidney cancer (it runs in families). Papillary kidney cancer can also occur sporadically, or without a family connection. More research is needed to determine whether treatments for papillary kidney cancer, such as bevacizumab and erlotinib, work in inherited or sporadic types of kidney cancer, and if so, whether there are any differences. Objectives: -To determine the effectiveness of the combination of bevacizumab and erlotinib as a treatment for patients with (1) metastatic HLRCC kidney cancer and (2) metastatic kidney cancer not associated with HLRCC (or sporadic papillary RCC). Eligibility: * Individuals 18 years of age or older who have been diagnosed with papillary kidney cancer that has spread beyond the kidneys. * Participants may have either HLRCC or sporadic papillary kidney cancer. Design: * Participants will be screened with a full medical history, physical examination, blood and urine tests, and computed tomography (CT) and other scans to evaluate tumor size and treatment options. * Participants will receive 28-day treatment cycles of bevacizumab (given intravenously every 2 weeks) and erlotinib (a tablet taken by mouth daily). * Every cycle, participants will return for regular blood and urine tests. Every other cycle, participants will have imaging scans to assess tumor size and response to treatment. Female participants who have uterine fibroid tumors related to their kidney cancer may have additional scans to assess tumor size and response to treatment. * Participants will continue to receive treatment on the study u
Interventions
- DRUG Bevacizumab
- DRUG Erlotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2010-05-06 |
| Est. Completion | 2022-06-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01130519
The ClinicalTrials.gov registry entry for NCT01130519 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 83 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 2 interventions - of which Bevacizumab is the first listed.
NCT01130519 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01130519 about?
NCT01130519 is a clinical study titled "A Phase II Study of Bevacizumab and Erlotinib in Subjects With Advanced Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC) or Sporadic Papillary Renal Cell Cancer". Background: * At the present time, there are no drugs that have been proven to work in patients with papillary kidney cancer that has spread (metastasized) beyond the kidneys. Researchers are interested in determining whether the combination of the drugs bevacizumab and erlotinib can be used to tre...
What is the current status of trial NCT01130519?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 83 participants. The study started on 2010-05-06. Estimated completion is 2022-06-08.
What interventions are being tested in trial NCT01130519?
The interventions under investigation include: Bevacizumab (DRUG), Erlotinib (DRUG).
Who is sponsoring clinical trial NCT01130519?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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