Tariquidar and Docetaxel to Treat Patients With Lung, Ovarian, Renal and Cervical Cancer
Status:
Completed
Trial end date:
2009-12-01
Target enrollment:
Participant gender:
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.