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NCT01352962 · ClinicalTrials.gov registry record · Phase 1
Gemcitabine, Carboplatin, and Lenalidomide for Treatment of Advanced/Metastatic Urothelial Cancer and Other Solid Tumors
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT01352962: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01352962 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 18 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01352962, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
Background: \- Gemcitabine and carboplatin are chemotherapy drugs used to treat several types of cancer, including cancer of the pancreas, bladder, ovaries, and lung. Lenalidomide, a drug that prevents the growth of new blood vessels in tumors, has been approved for treatment of certain blood cancers, but it has not yet been approved for use in combination with gemcitabine and carboplatin. Researchers are interested in determining the safest and most effective dose of this combined form of chemotherapy for solid tumors, particularly for urothelial cancer (tumors of the bladder, urethra, ureter, or renal pelvis). Objectives: * To evaluate the safety and effectiveness of combined lenalidomide, gemcitabine, and carboplatin as a treatment for solid tumor cancers. * To evaluate the safety and effectiveness of combined lenalidomide, gemcitabine, and carboplatin as a treatment for urothelial (bladder) cancer. Eligibility: * Individuals at least 18 years of age who have been diagnosed with solid tumors that have not responded to standard treatments. * Individuals at least 18 years of age who have been diagnosed with urothelial cancer that has not responded to standard treatments. Design: * Participants will be screened with a physical examination, medical history, blood tests, and tumor imaging studies. * Participants with urothelial cancer will receive lenalidomide alone for the first 14 days of a 21-day cycle before starting the first full treatment cycle. * All participants will receive gemcitabine on days 1 and 8, and carboplatin on day 1 only, of every 21-day treatment cycle. Lenalidomide will be taken daily at home for the first 14 days of each cycle. Participants will be asked to take aspirin or other medications to prevent the possibility of blood clots. * Participants may receive up to six cycles of treatment with this combination. If after six cycles the cancer has not grown or has shrunk, participants may continue to take lenalidomide alone for an addition
Interventions
- DRUG Carboplatin
- DRUG Lenalidomide
- DRUG Gemcitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2011-09-26 |
| Est. Completion | 2018-07-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01352962
The ClinicalTrials.gov registry entry for NCT01352962 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 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 Carboplatin is the first listed.
NCT01352962 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01352962 about?
NCT01352962 is a clinical study titled "Gemcitabine, Carboplatin, and Lenalidomide for Treatment of Advanced/Metastatic Urothelial Cancer and Other Solid Tumors". Background: \- Gemcitabine and carboplatin are chemotherapy drugs used to treat several types of cancer, including cancer of the pancreas, bladder, ovaries, and lung. Lenalidomide, a drug that prevents the growth of new blood vessels in tumors, has been approved for treatment of certain blood cance...
What is the current status of trial NCT01352962?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2011-09-26. Estimated completion is 2018-07-06.
What interventions are being tested in trial NCT01352962?
The interventions under investigation include: Carboplatin (DRUG), Lenalidomide (DRUG), Gemcitabine (DRUG).
Who is sponsoring clinical trial NCT01352962?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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