NIH Clinical Research Studies

Protocol Number: 03-C-0284

Active Followup, Protocols NOT Recruiting New Patients

Title:
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
Number:
03-C-0284
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, and possibly a bone scan or other imaging tests needed to evaluate the cancer; electrocardiogram (EKG); and possibly echocardiogram.

Participants will undergo the following tests and procedures:

- Tumor biopsy. Before starting chemotherapy, a small piece of tumor is removed to study the P-glycoprotein pump and to determine the tumor genetics.

- 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. 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. Treatment will continue for two cycles after all the cancer is gone, or until surgery is done to remove some or all of the remaining cancer, or, if surgery is not an option, until the cancer has grown to where it is defined as progressive disease.

- Nuclear scans. Nuclear scans are done during the first treatment cycle before and after administration of tariquidar to see how well the P glycoprotein responds to the drug.

- CT scans. CT scans are done every two treatment cycles to follow disease progress.

- Surgery. Surgery to remove areas of cancer may be considered at any point during the study (including before beginning treatment), if it is deemed beneficial. Treatment with the study drugs will begin or resume after surgery. The length of treatment will depend on the response to treatment before the surgery and on whether there is any cancer remaining after the surgery.

Patients will continue on the study as long as the treatment helps control their disease. When a patient stops the study, he or she will have blood tests, a physical examination, and a CT or MRI scan to determine the response to therapy and guide future treatment.

Sponsoring Institute:
National Cancer Institute (NCI)
Recruitment Detail
Type: No longer recruiting/follow-up only
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
Special Instructions:
Currently Not Provided
Keyword(s):
Pharmacokinetics
Pharmacodynamics
P-glycoprotein Inhibition
Multidrug Resistance Reversal
Molecular Target
Recruitment Keyword(s):
Lung Cancer
Ovarian Cancer
Cervical Cancer
Renal Cancer
Condition(s):
Lung Neoplasms
Ovarian Neoplasms
Cervix Neoplasms
Renal Neoplasms
Investigational Drug(s):
XR9576
Investigational Device(s):
None
Interventions:
Drug: XR9576
Supporting Site:
National Cancer Institute

Contact(s):
This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):
Ling V, Thompson LH. Reduced permeability in CHO cells as a mechanism of resistance to colchicine. J Cell Physiol. 1974 Feb;83(1):103-16. No abstract available.

Akiyama S, et al, Isolation and genetic characterization of human KB cell lines resistant to multiple drugs. Somat Cell Mol Genet. 1985 Mar;11(2):117-26.

Beck WT, Cirtain MC, Lefko JL. Energy-dependent reduced drug binding as a mechanism of Vinca alkaloid resistance in human leukemic lymphoblasts. Mol Pharmacol. 1983 Nov;24(3):485-92.

Active Followup, Protocols NOT Recruiting New Patients

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