At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Histologically or cytologically confirmed lung, cervical, or ovarian cancer (including primary peritoneal and fallopian tube cancers) with prior standard treatment and no known standard therapy to extend survival
- ✓Histologically or cytologically confirmed renal cell carcinoma (clear cell, type 1/II papillary, chromophobe, collecting duct, medullary) with prior sunitinib or sorafenib (unless ineligible) and prior or evaluated-for IL-2 therapy
- ✓ECOG performance status 0-2
- ✕Pregnant or nursing women
- ✕Second malignancy not yet treated or that would complicate primary objective
- ✕Active, uncontrolled infection or other nonmalignant systemic disease affecting medical fitness
- ✕HIV seropositivity
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Clinical Trial of the P-Glycoprotein Antagonist, Tariquidar (XR9576), in Combination With Docetaxel in Patients With Lung, Ovarian, Renal and Cervical Cancer: Analysis of the Interaction Between Tariquidar and Docetaxel
In Brief
A Phase 2 clinical trial evaluating docetaxel, tariquidar, and 1 other intervention for Lung Neoplasms and 3 related conditions. Completed, enrolled 48 participants across 1 site.
Detailed 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 pharmacokinetic data. Patients will be hospitalized for several days during this cycle to gather research data). The tariquidar dose remains the same throughout the study. Docetaxel may be increased or decreased from cycle to cycle, based on side effects.
Study Details
Timeline
Interventions
Patients receive docetaxel intravenous (IV) over 1 hour on days 1 and 8.
Patients receive tariquidar intravenous (IV) over 30 minutes on days 8 and 22.
Bolus injection of 29 mCi of 99mTc-sestamibi intravenously for each imaging study.