|
Tariquidar and Docetaxel to Treat Patients with Lung, Ovarian, and Cervical Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Tariquidar and Docetaxel to Treat Patients with Lung, Ovarian, and Cervical Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Tariquidar and Docetaxel to Treat Patients with Lung, Ovarian, and Cervical Cancer Clinical research trials and Tariquidar and Docetaxel to Treat Patients with Lung, Ovarian, and Cervical Cancer health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Tariquidar and Docetaxel to Treat Patients with Lung, Ovarian, and Cervical Cancer. Tariquidar and Docetaxel to Treat Patients with Lung, Ovarian, and Cervical Cancer Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Tariquidar and Docetaxel to Treat Patients with Lung, Ovarian, and Cervical Cancer clinical trial. Test subjects typically receive the most expert healthcare available for their Tariquidar and Docetaxel to Treat Patients with Lung, Ovarian, and Cervical Cancer condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "T" Clinical Trials Conditions > Tariquidar and Docetaxel to Treat Patients with Lung, Ovarian, and Cervical Cancer  Tariquidar and Docetaxel to Treat Patients with Lung, Ovarian, and Cervical Cancer
Tariquidar and Docetaxel to Treat Patients with Lung, Ovarian, and Cervical Cancer
For Condition: Lung Neoplasms,Cervix Neoplasms,Ovarian Neoplasms
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: 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.
Details: Intrinsic and acquired drug resistance remain major obstacles in the treatment of cancer. Accumulating evidence indicates that in some malignancies Pglycoprotein (Pgp) can confer resistance, and that its reversal can improve therapeutic outcome. Clinical trials investigating Pgp antagonists have been hampered by the occurrence of unpredictable pharmacokinetic interactions, which have required dose reductions of the chemotherapeutic agents to avert excessive toxicity. Tariquidar (XR9576) is a new Pgp antagonist that is more potent and has prolonged activity. Phase I trials with paclitaxel, vinorelbine, and doxorubicin have demonstrated that tariquidar (XR9576) has minimal pharmacokinetic interactions while surrogate studies have confirmed in vivo inhibition of Pgp-mediated drug transport. This study seeks to determine the pharmacokinetic interaction, if any, between docetaxel and tariquidar and to evaluate the potential for activity in lung, ovarian, primary peritoneal, fallopian tube and cervical cancers. The secondary goal is to evaluate the impact of tariquidar on uptake of (99m)Tc-sestamibi in recurrent or metastatic tumors of patients with lung, ovarian, or cervical cancer.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Patients must fulfill all of the following criteria to be eligible for study admission: 1. Age greater than or equal to 18 years. 2. Histologic or cytologic confirmation of lung, cervical, or ovarian cancer, following at least one standard treatment regimen, and for which there is no known standard therapy capable of extending life expectancy. Female patients with primary papillary carcinoma of the peritoneum and fallopian tube cancers will be included in the latter group, as the disease entities are closely associated with epithelial ovarian carcinoma, can be difficult to distinguish, have a similar epithelial origin, and are treated in an identical manner. 3. Performance status: ECOG 0-2. 4. Life expectancy of 3 months or greater. 5. Suitable candidate for receiving planned therapy as evidenced by screening laboratory assessments hematologic, renal, hepatic, and metabolic functions: platelet count greater than or equal to 90,000/mL absolute granulocyte count (AGC) greater than or equal to 1,500/mL, serum creatinine less than or equal to 1.5 mg/dl (or if greater than 1.5, a measured 24 hour creatinine clearance greater than or equal to 50 mL/min), SGPT and SGOT less than or equal to 2.5 x NL, and bilirubin less than or equal to 1.5 x NL (in patients with clinical evidence of Gilbert's disease, less than or equal to 3 x NL). 6. Patients must be greater than or equal to 4 weeks from prior radiation or chemotherapy; greater than 2 weeks from hormonal therapy; greater than 4 weeks from prior experimental therapy; greater than 6 weeks from mitomycin C; and greater than 8 weeks from prior UCNO1 treatment. 7. No serious intercurrent medical illness. 8. Measurable disease by radiographic means or physical examination. For ovarian cancer, assessable disease by CA125 measurement is allowed. 9. Willingness to sign a written informed consent form, and to comply with the protocol. EXCLUSION CRITERIA: The following patient populations are not eligible for study: 1. Pregnant or nursing women are not eligible; women of childbearing age must agree to use an effective method of contraception. Pregnant women are not eligible because of teratogenic effects of chemotherapy. 2. The presence of an active second malignancy. 3. Patients who are poor medical risk because of active, uncontrolled infection or other non-malignant systemic disease. 4. HIV seropositive patients. Patients infected with the HIV virus will be excluded from this trial because the effect of the combination of tariquidar and docetaxel on HIV replication and/or the immune system is unknown and potentially harmful. 5. Patients receiving agents which have major interactions with the CYP3A4 drug metabolizing system and which cannot be discontinued may not be included in the trial. These agents are: amiodarone, clarithromycin, erythromycin, fluconazole, intraconazole, ketoconazole, indinavir, nelfinavir, ritonavir, saquinavir, delaviridine, voriconazole, and troleandomycin. 6. Untreated brain metastases (or local treatment of brain metastases within the last 6 months) due to the poor prognosis of these patients and difficulty ascertaining the cause of neurologic toxicities.
Total Enrollment: 40
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 030284; 03-C-0284
Study Start Date: September 10, 2003
Record last reviewed: August 25, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00069160
Other Cervix Neoplasms Studies:
1. Tariquidar and Docetaxel to Treat Patients with Lung, Ovarian, and Cervical Cancer
2. Will Radiation/Chemotherapy Treatment of Cervical Cancer Work Better With Medication That May Improve Anemia?
3. Pilot Study of ZD1839 (Iressa, Gefitinib) in Patients with Advanced Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, or Cervical Cancer
Related Studies:
Other Cervix Neoplasms Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Tariquidar and Docetaxel to Treat Patients with Lung, Ovarian, and Cervical Cancer
|
|
|
|
|
|
|
|
