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PS-341 Plus Carboplatin in Platinum and Taxane Resistant Recurrent Ovarian Cancer, Primary Peritoneal Cancer, and Fallopian Tube 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 PS-341 Plus Carboplatin in Platinum and Taxane Resistant Recurrent Ovarian Cancer, Primary Peritoneal Cancer, and Fallopian Tube Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. PS-341 Plus Carboplatin in Platinum and Taxane Resistant Recurrent Ovarian Cancer, Primary Peritoneal Cancer, and Fallopian Tube Cancer Clinical research trials and PS-341 Plus Carboplatin in Platinum and Taxane Resistant Recurrent Ovarian Cancer, Primary Peritoneal Cancer, and Fallopian Tube 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 PS-341 Plus Carboplatin in Platinum and Taxane Resistant Recurrent Ovarian Cancer, Primary Peritoneal Cancer, and Fallopian Tube Cancer. PS-341 Plus Carboplatin in Platinum and Taxane Resistant Recurrent Ovarian Cancer, Primary Peritoneal Cancer, and Fallopian Tube 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 PS-341 Plus Carboplatin in Platinum and Taxane Resistant Recurrent Ovarian Cancer, Primary Peritoneal Cancer, and Fallopian Tube Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their PS-341 Plus Carboplatin in Platinum and Taxane Resistant Recurrent Ovarian Cancer, Primary Peritoneal Cancer, and Fallopian Tube 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 > "P" Clinical Trials Conditions > PS-341 Plus Carboplatin in Platinum and Taxane Resistant Recurrent Ovarian Cancer, Primary Peritoneal Cancer, and Fallopian Tube Cancer  PS-341 Plus Carboplatin in Platinum and Taxane Resistant Recurrent Ovarian Cancer, Primary Peritoneal Cancer, and Fallopian Tube Cancer
PS-341 Plus Carboplatin in Platinum and Taxane Resistant Recurrent Ovarian Cancer, Primary Peritoneal Cancer, and Fallopian Tube Cancer
For Condition: Primary Peritoneal Cancer,Fallopian Tube Cancer,Ovarian Cancer
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center , Millennium Pharmaceuticals
Synopsis: The goal of this clinical research study is to find the highest safe dose of PS-341 that can be given with carboplatin chemotherapy as a treatment for patients with ovarian, abdominal, or fallopian tube cancer. Researchers also hope to find out if giving these drugs together will help shrink or slow the growth of tumors in patients who are considered resistant to platinum drugs. The safety of these drugs will also be studied.
Details: 1. Establish the dose-limiting toxicity and maximally tolerated dose of PS-341 and carboplatinum when given in combination to patients with platinum- and taxane-resistant recurrent ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. 2. Determine the proportion of patients treated with PS-341 in combination with carboplatinum who achieve a confirmed complete response (CR) or partial response (PR) or have stable disease (SD).
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Dose Comparison, Expanded Access Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry Criteria: Inclusion: - Patients must have histologically-confirmed ovarian cancer, primary peritoneal cancer, or fallopian tube cancer with advanced and/or metastatic disease. All patients must be considered platinum- and taxane- resistant. - Platinum resistance is defined as: a) Progression of disease during platinum or taxane chemotherapy, or b) Progression of disease within 6 months of completing platinum or taxane chemotherapy c) Failure to achieve a complete response, with persistent macroscopic disease, after 6 cycles of chemotherapy, if the last two cycles had no measurable change in disease status - Patients may have had any number of prior chemotherapy regimens, except high dose chemotherapy an/or peripheral blood stem cell transplantation (high dose: higher than the standard doses of chemotherapy) - Patients must have measurable disease. - Zubrod performance status of < 2. - Expected survival of three months or longer. - Patients must give voluntary written informed consent before performance of any study-related procedure not part of normal medical care. - Adequate liver, renal and bone marrow function, defined as: Absolute neutrophil count (ANC) >1.5x109 /L. Platelets >100x109/L Total bilirubin <1.7 umol/L Alanine transaminase (ALT) and aspartate transaminase (AST) <1.5xULN Alkaline phosphatase <2.5xULN. Serum creatinine <1.5xULN. Exclusion: - Chemotherapy within four weeks of first course of PS-341. (Patients may have been on hormonal therapy). - Patients who previously received high-dose chemotherapy (higher than the standard doses of chemotherapy) and/or peripheral blood stem cell transplantation. - Radiation therapy within four weeks of enrollment (excepting palliative XRT). - Patients not recovered from toxic effects of previous chemotherapy, radiation therapy, or antibody therapy. - Patients with > Grade 2 peripheral neuropathy. - Surgery within four weeks of study enrollment. - History of severe hypersensitivity reaction to carboplatin - Electrocardiographic evidence of acute ischemia or new conduction system abnormalities. - Myocardial infarction within six months of enrollment. - Patients with brain metastases or central nervous system disease as evidenced by clinical symptoms. - History of other malignancy, except nonmelanoma skin cancer or carcinoma in-situ of the cervix, unless in complete remission and off all therapy for that disease for a minimum of 5 years. Chemotherapy given for prior cancers will not exclude patients from participating in this study. - Patients with previously documented human immunodeficiency virus (HIV) infection. HIV-positive patients are excluded from the study based on theoretical concerns regarding the effect of PS-341 on certain aspects of immune function. NF-KB is a critical T cell activation protein (including through CD40L/CD 154 stimulation) and also is involved in cytokine production. Because PS 341 effectively blocks NF-KB and therefore could reduce or block the ability of T lymphocytes and other immune cells to fight HIV, PS-341 should not be administered to HIV-positive patients. Additional experiments in animal models are being conducted to better elucidate the effects of PS-341 on HIV. - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. - Other serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol. - Patients who are pregnant, suspected to be pregnant, or breast-feeding. - Patients with a known hypersensitivity to PS-341, boron, or manitol.
Total Enrollment: 24
Location and Contact Information:
Overall Study Official:
PedroRamirez, Study Chair, University of Texas M. D. Anderson Cancer Center
University of Texas M. D. Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting Taren Johnston 713-404-4519
Additional Information:
Study ID Numbers: ID02-114;
Study Start Date: April 2003
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00059618
Other Primary Peritoneal Cancer Studies:
1. Tamoxifen Compared With Thalidomide in Treating Women With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
2. Cisplatin Plus Irinotecan in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer
3. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
4. PS-341 Plus Carboplatin in Platinum and Taxane Resistant Recurrent Ovarian Cancer, Primary Peritoneal Cancer, and Fallopian Tube Cancer
5. Combination Chemotherapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
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PS-341 Plus Carboplatin in Platinum and Taxane Resistant Recurrent Ovarian Cancer, Primary Peritoneal Cancer, and Fallopian Tube Cancer
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