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A Phase II Trial of Trastuzumab and Paclitaxel in Patients with HER2 Overexpressing Breast and Ovarian Tumors Who Have Relapsed or Progressive Disease Following Conventional Cytotoxic Chemotherapy Regimens for Metastatic Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on A Phase II Trial of Trastuzumab and Paclitaxel in Patients with HER2 Overexpressing Breast and Ovarian Tumors Who Have Relapsed or Progressive Disease Following Conventional Cytotoxic Chemotherapy Regimens for Metastatic Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. A Phase II Trial of Trastuzumab and Paclitaxel in Patients with HER2 Overexpressing Breast and Ovarian Tumors Who Have Relapsed or Progressive Disease Following Conventional Cytotoxic Chemotherapy Regimens for Metastatic Cancer Clinical research trials and A Phase II Trial of Trastuzumab and Paclitaxel in Patients with HER2 Overexpressing Breast and Ovarian Tumors Who Have Relapsed or Progressive Disease Following Conventional Cytotoxic Chemotherapy Regimens for Metastatic Cancer healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including A Phase II Trial of Trastuzumab and Paclitaxel in Patients with HER2 Overexpressing Breast and Ovarian Tumors Who Have Relapsed or Progressive Disease Following Conventional Cytotoxic Chemotherapy Regimens for Metastatic Cancer. A Phase II Trial of Trastuzumab and Paclitaxel in Patients with HER2 Overexpressing Breast and Ovarian Tumors Who Have Relapsed or Progressive Disease Following Conventional Cytotoxic Chemotherapy Regimens for Metastatic Cancer Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a A Phase II Trial of Trastuzumab and Paclitaxel in Patients with HER2 Overexpressing Breast and Ovarian Tumors Who Have Relapsed or Progressive Disease Following Conventional Cytotoxic Chemotherapy Regimens for Metastatic Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their A Phase II Trial of Trastuzumab and Paclitaxel in Patients with HER2 Overexpressing Breast and Ovarian Tumors Who Have Relapsed or Progressive Disease Following Conventional Cytotoxic Chemotherapy Regimens for Metastatic Cancer condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Phase II Trial of Trastuzumab and Paclitaxel in Patients with HER2 Overexpressing Breast and Ovarian Tumors Who Have Relapsed or Progressive Disease Following Conventional Cytotoxic Chemotherapy Regimens for Metastatic Cancer  A Phase II Trial of Trastuzumab and Paclitaxel in Patients with HER2 Overexpressing Breast and Ovarian Tumors Who Have Relapsed or Progressive Disease Following Conventional Cytotoxic Chemotherapy Regimens for Metastatic Cancer
A Phase II Trial of Trastuzumab and Paclitaxel in Patients with HER2 Overexpressing Breast and Ovarian Tumors Who Have Relapsed or Progressive Disease Following Conventional Cytotoxic Chemotherapy Regimens for Metastatic Cancer
For Condition: Breast Neoplasm,Neoplasm Metastasis,Ovarian Neoplasm
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: Clinical studies have shown that trastuzumab is clinically effective against HER2 expressing tumors. The molecular basis for this activity is unknown. We have initiated a pharmaco-proteomics study of neoplastic tissues from breast and ovarian cancer patients undergoing treatment with trastuzumab and paclitaxel. Using laser capture microdissection techniques and quantitative protein analysis, a validated microarray protein chip to assess protein levels in cancer cells is being used to characterize and quantify changes in molecular intermediates within the HER2 signaling pathway. The primary study objectives are: To characterize molecular pharmacodynamic and intermediate endpoint biomarkers of trastuzumab therapy in biopsied tissues (molecular/pharmacodynamic study) To evaluate the safety and efficacy of trastuzumab in combination with paclitaxel in patients with HER2 overexpressing metastatic ovarian cancer (phase II efficacy study). This study is an open label, single institution, non-randomized phase II trial prospectively designed to meet its molecular and clinical objectives. The molecular (pathologic) objective will be met by measuring differences in HER2 receptor levels, downstream mediators of HER2 signaling (proliferation), and cell cycle regulation at baseline and 4 or 12 weeks time points. To achieve this objective, 33 patients are required. Statistical strength will be gained if 55 patients are accrued. Breast and ovarian cancer patients are eligible for evaluation. The goal of the clinical objective is to determine whether the clinical responses observed in ovarian cancers are sufficient to justify further clinical development. A two-stage optimal design for phase II trials has prospectively been defined. To achieve this objective, a minimum of 22 to a maximum of 40 patients is required. The greater patient number is required if at least 3 responses are noted in the first 22 volunteers.
Details: Alteration in the expression and activation of protein tyrosine kinases and cell cycle regulatory genes not only can lead directly to the perturbation of growth regulation but also may affect the sensitivity of cancer cells to conventional chemotherapy. Trastuzumab (Herceptin), an antibody that may disrupt c-erbB2 signaling, has received FDA approval for the treatment of patients with metastatic breast cancer. Early clinical studies have shown that this antibody's anti-tumor effects can be additive and at times synergistic with some conventional chemotherapeutic agents. The mechanisms by which this occurs are unknown. In this protocol, we describe a pharmaco-proteomics study of normal and neoplastic tissues from patients undergoing treatment with trastuzumab (Herceptin) and paclitaxel employing laser capture microdissection techniques and quantitative protein analysis using a microarray protein chip developed within the NCI Laboratory of Pathology. This pharmacodynamic/pharmacokinetic study will constitute the first clinical attempt to characterize as well as quantify molecular intermediates and biomarkers following trastuzumab (Herceptin) treatment.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Age greater than or equal to 18 years. Histologic or cytologic confirmation of metastatic breast cancer with HER2 overexpression. Measurable disease by radiographic means or physical examination which may be biopsied safely under local anesthesia. Performance Status ECOG 0-2. The ability to understand and willingness to sign a written informed consent form. Neutrophil count greater than or equal to 1,000 cells/mm(3). Platelet count greater than or equal to 75,000 cells/mm(3). Liver enzymes ALT and AST less than or equal to 5 times the upper limit of normal. Bilirubin less than or equal to 3.0 times the upper limit of normal. EXCLUSION CRITERIA: Pregnant or nursing women and women of childbearing potential unless using effective contraception as determined by the patient's physician. Individuals who have had prior Herceptin therapy are not eligible.
Total Enrollment: 55
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 990121; 99-C-0121
Study Start Date: June 10, 1999
Record last reviewed: February 16, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001819
Other Neoplasm Metastasis Studies:
1. A Phase II Trial of Orally Administered CAI for Patients with Persistent or Refractory Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
2. Phase II CT-2103/Carboplatin in Ovarian Cancer
3. Experimental Drug SS1(dsFv)-PE38 to Treat Cancer
4. A Multi-Institutional Phase II Study of Cyclophosphamide, Paclitaxel, Cisplatin with G-CSF for Patients with Newly Diagnosed Advanced Stage Ovarian Cancer
5. A Safety and Tolerability Study of Oral TAK-165 Administered to Subjects with Tumors Known to Express HER2
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A Phase II Trial of Trastuzumab and Paclitaxel in Patients with HER2 Overexpressing Breast and Ovarian Tumors Who Have Relapsed or Progressive Disease Following Conventional Cytotoxic Chemotherapy Regimens for Metastatic Cancer
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