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NCT00069160 · ClinicalTrials.gov registry record · Phase 2
Tariquidar and Docetaxel to Treat Patients With Lung, Ovarian, Renal and Cervical Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
NCT00069160: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00069160 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 48 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00069160, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
Study Summary
The purpose of this study is three-fold: 1) to examine the ability of the experimental drug tariquidar to improve chemotherapy results by blocking a protein (P-glycoprotein) on some cancer cells that acts to pump out cancer drugs; 2) examine how tariquidar interacts with the cancer drug docetaxel; and 3) evaluate the effectiveness of combination treatment with tariquidar and docetaxel in treating patients with lung, ovarian, or cervical cancer. Patients 18 years of age and older with recurrent or metastatic (spreading) lung, cervical, or ovarian cancer who cannot benefit from any standard treatment may be eligible for this study. Candidates will be screened with a medical history and physical examination; review of pathology slides; blood and urine tests; imaging tests, including computed tomography (CT) or magnetic resonance imaging (MRI) scans; chest x-ray, electrocardiogram (EKG); and possibly echocardiogram. Participants will undergo the following tests and procedures: Blood draw. Blood is drawn before treatment begins to establish baseline levels for future blood tests. Blood counts are done twice weekly after chemotherapy begins. Central venous catheter placement. A plastic tube is put into a major vein in the chest. It is used to give the study drugs or other medications, including antibiotics and blood transfusions, if needed, and to withdraw blood samples. The line is usually placed under local anesthesia in the radiology department or the operating room. It can stay in the body for months or be removed after each treatment is completed. Chemotherapy. Treatment cycles are 21 days. Both drugs are given on day 1 of each cycle. First, tariquidar is given as a 30-minute infusion. One hour after the tariquidar infusion, docetaxel is infused over 1 hour. (For the first cycle only, docetaxel is given in divided doses one week apart and tariquidar is administered on either day 1 or day 8. The order of tariquidar administration is randomized to generate optimal
Interventions
- DRUG docetaxel
- DRUG tariquidar
- OTHER 99mTc-sestamibi imaging
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2003-09 |
| Est. Completion | 2009-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00069160
The ClinicalTrials.gov registry entry for NCT00069160 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 48 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 docetaxel is the first listed.
NCT00069160 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00069160 about?
NCT00069160 is a clinical study titled "Tariquidar and Docetaxel to Treat Patients With Lung, Ovarian, Renal and Cervical Cancer". The purpose of this study is three-fold: 1) to examine the ability of the experimental drug tariquidar to improve chemotherapy results by blocking a protein (P-glycoprotein) on some cancer cells that acts to pump out cancer drugs; 2) examine how tariquidar interacts with the cancer drug docetaxel; a...
What is the current status of trial NCT00069160?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2003-09. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00069160?
The interventions under investigation include: docetaxel (DRUG), tariquidar (DRUG), 99mTc-sestamibi imaging (OTHER).
Who is sponsoring clinical trial NCT00069160?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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