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Phase II Study to Evaluate Tariquidar (XR9576), a Selective MDR-1 Inhibitor, in Chemotherapy Resistant Advanced Breast 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 Phase II Study to Evaluate Tariquidar (XR9576), a Selective MDR-1 Inhibitor, in Chemotherapy Resistant Advanced Breast Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Phase II Study to Evaluate Tariquidar (XR9576), a Selective MDR-1 Inhibitor, in Chemotherapy Resistant Advanced Breast Cancer Clinical research trials and Phase II Study to Evaluate Tariquidar (XR9576), a Selective MDR-1 Inhibitor, in Chemotherapy Resistant Advanced Breast 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 Phase II Study to Evaluate Tariquidar (XR9576), a Selective MDR-1 Inhibitor, in Chemotherapy Resistant Advanced Breast Cancer. Phase II Study to Evaluate Tariquidar (XR9576), a Selective MDR-1 Inhibitor, in Chemotherapy Resistant Advanced Breast 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 Phase II Study to Evaluate Tariquidar (XR9576), a Selective MDR-1 Inhibitor, in Chemotherapy Resistant Advanced Breast Cancer clinical trial. Test subjects typically receive the most expert healthcare available for their Phase II Study to Evaluate Tariquidar (XR9576), a Selective MDR-1 Inhibitor, in Chemotherapy Resistant Advanced Breast 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.
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Home > "P" Clinical Trials Conditions > Phase II Study to Evaluate Tariquidar (XR9576), a Selective MDR-1 Inhibitor, in Chemotherapy Resistant Advanced Breast Cancer  Phase II Study to Evaluate Tariquidar (XR9576), a Selective MDR-1 Inhibitor, in Chemotherapy Resistant Advanced Breast Cancer
Phase II Study to Evaluate Tariquidar (XR9576), a Selective MDR-1 Inhibitor, in Chemotherapy Resistant Advanced Breast Cancer
For Condition: Breast Neoplasms
Status: Terminated
Sponsor(s): QLT Inc ,
Synopsis: The primary objective of this phase II study is to assess if XR9576, a selective MDR-1 inhibitor, is able to reverse primary doxorubicin or taxane resistance in advanced breast cancer. Clinical activity will be measured by objective tumor response rates observed after treatment with XR9576 in combination with taxane or anthracycline containing chemotherapy in patients previously resistant to the same agent(s). The secondary objectives of the study are to assess the biological activity of XR9576 and evaluate MDR-1 expression in these tumors. The MDR-1 inhibitory activity of XR9576 will be evaluated by serial sestamibi scans of the tumor. MDR-1 expression will be detected by immunohistochemistry.
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Inclusion criteria: - Histologically proven breast cancer with primary resistance to anthracyclines (doxorubicin, epirubicin) or taxane (paclitaxel, docetaxel) or both. Primary chemotherapy resistance is defined for the purpose of this protocol as any of the following: a. Progression after a minimum of 1 cycles of therapy, or b. Stable disease after a minimum of 2 cycles of therapy or, c. Relapse within 6 months after completion of an anthracycline or/and taxane containing chemotherapy regimen. - Patients with anthracycline/taxane resistance INOPERABLE, locally advanced breast cancer are eligible. - Patients must have measurable disease as defined by the RECIST criteria in their breast/nodal regions or at a distant organ site(s). - There is no limit on prior hormonal therapies but only one prior chemotherapy for metastatic breast cancer is allowed. - Patients may receive concomitant bisphosphonate therapy for bone metastasis. - Patients may continue Herceptin if it has previously been started. Herceptin cannot be added to the chemotherapy regimen as a new agent at the same time when XR9576 is initiated. - Patients much have recovered from acute toxic effects of any prior therapy. - Zubrod performance status less than or equal to 2. - Adequate bone marrow function: platelets greater than or equal to 100,000/mm3, ANC greater than or equal to 1500 cells/mm3, hemoglobin greater than or equal to 8g/dl. - Normal renal function: creatinine less than or equal to 2.0 mg/dl. Adequate liver function: bilirubin less than or equal to 1.5 mg/dl. Transaminase (SGOT) and alkaline phosphatase must be less than or equal to 1.5 x of the upper limit of normal in the absence of bone or liver metastasis, or less than or equal to 2.5 x of the upper limit of normal in the presence of radiologically apparent liver metastasis or bone metastasis, respectively. - Female patients must be of non-lactating and using adequate contraception if premenopausal. Beta-HCG will be checked in premenopausal patients if clinically indicated. - Patients with brain metastases whose disease remained stable for more than 3 months after completing therapy to the brain are eligible. - Written informed consent. Exclusion criteria: - More than 1 chemotherapy regimen for metastatic breast cancer. - Patients who relapsed more than 6 months after completion of anthracycline or taxane therapy. - Current treatment with a non-taxane, non-anthracycline based chemotherapy. - Uncontrolled psychiatric, or social (addictive) disorders that would preclude obtaining informed consent or patient participation in the study. - Clinical contraindication of continued anthracycline or taxane therapy. For patients who show primary resistance to anthracyclines this includes greater than 300 mg/m2 maximum life-time cumulative dose of doxorubicin, symptomatic heart failure, history of heart failure, recent myocardial infarction (less than 6 months) or left ventricular ejection fraction below normal range. For patients with primary resistance to taxanes, persistent grade 2 or greater neuropathy (neuropathy that interferes with function). - Patients with operable primary breast cancer are not eligible. - Patients who have developed primary resistance to the chemotherapy combination of doxorubicin/docetaxel.
Total Enrollment: 30
Location and Contact Information:
Overall Study Official:
GraemeBoniface, Study Director,
Medical Center of Vincennes
Vincennes, Indiana, 47591
United States
Florida Oncology Associates
Jacksonville, Florida, 32207-5905
United States
Arlington Cancer Center
Arlington, Texas, 76012
United States
MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Additional Information:
Study ID Numbers: TQD BRST 001;
Study Start Date:
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00048633
Other Breast Neoplasms Studies:
1. Antimetabolite Induction, High-Dose Alkylating Agent Consolidation and Retroviral Transduction of the MDR1 Gene into Peripheral Blood Progenitor Cells Followed by Intensification Therapy with Sequential Paclitaxel and Doxorubicin for Stage 4 Breast Cancer
2. A Prospective, Randomized, Phase III Trial of FLAC (5-Fluorouracil, Leucovorin, Adriamycin, Cytoxan) Chemotherapy with GM-CSF (Granulocyte-Macrophage Colony-Stimulating Factor) Versus PIXY 321 in Advanced Breast Cancer
3. Evaluation of Bay 59-8862 in Taxane-Resistant Metastatic Breast Cancer Patients
4. Evaluation of BNP7787 for the Prevention of Neurotoxicity in Metastatic Breast Cancer Patients Receiving Weekly Paclitaxel
5. Phase 3 study of LY353381 vs tamoxifen in women with locally advanced or metastatic breast cancer.
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Phase II Study to Evaluate Tariquidar (XR9576), a Selective MDR-1 Inhibitor, in Chemotherapy Resistant Advanced Breast Cancer
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