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Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer Clinical research trials and Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer healthcare trials happen in many 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 drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer. Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "L" Clinical Trials Conditions > Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer  Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer
Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer
For Condition: Fallopian Tube Cancer,uterine sarcoma,Cervical Cancer,ovarian sarcoma,ovarian carcinosarcoma,Endometrial Cancer
Status: No longer recruiting
Sponsor(s): AGO Ovarian Cancer Study Group ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combining liposomal doxorubicin with carboplatin in treating patients who have gynecologic cancer.
Details: OBJECTIVES: - Determine the maximum tolerated dose of doxorubicin HCl liposome when administered with carboplatin in patients with gynecological tumors. - Determine the dose-limiting toxicity of this regimen in these patients. - Determine the kind, frequency, severity, and duration of adverse events in patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of doxorubicin HCl liposome. Patients receive doxorubicin HCl liposome IV over 60 minutes followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 28 days for 6 courses. Cohorts of 3-6 patients receive escalating doses of doxorubicin HCl liposome until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued and treated at the MTD as above. Patients are followed at 4-6 weeks and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 12-24 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed fallopian tube cancer, Muellerian mixed tumor, endometrial cancer, uterine sarcoma, ovarian cancer with sarcoma parts, or cervical cancer - No ovarian epithelial cancer PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 OR - Karnofsky 70-100% Life expectancy: - At least 3 months Hematopoietic: - Absolute neutrophil count at least 1,500/mm3 - Platelet count at least 100,000/mm3 - Hemoglobin greater than 10.0 g/dL Hepatic: - Bilirubin no greater than 1.25 times upper limit of normal Renal: - Glomerular filtration rate at least 60 mL/min Cardiovascular: - No atrial or ventricular arrhythmias - No congestive heart failure even if stabilized on medication - No New York Heart Association class III or IV heart disease - No myocardial infarction within the past 6 months Other: - No pre-existing sensory or motor neuropathy grade 2 or greater - No active infection - No other serious medical condition that would preclude study - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior immunotherapy Chemotherapy: - No more than 1 prior chemotherapy regimen for the malignancy - No other concurrent chemotherapy Endocrine therapy: - Prior hormonal therapy within the past 10 days allowed - No concurrent hormonal therapy Radiotherapy: - At least 6 weeks since prior radiotherapy to no more than 25% of bone marrow Surgery: - Not specified Other: - At least 30 days since prior experimental agents - No other concurrent therapies that would preclude study - No concurrent participation in another study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AndreasBois, Study Chair, Dr. Hors t- Schmidt - Kliniken
Klinikum Rechts Der Isar/Technische Universitaet Muenchen
Munich (Muenchen), , D-81675
Germany
Frauenklinik der MHH
Hannover, , 30659
Germany
Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet
Greifswald, , D-17487
Germany
Vincentius Krankenhaus
Karlsruhe, , D-76137
Germany
Universitaetsklinik Duesseldorf
Duesseldorf, , D-40225
Germany
Medizinische Klinik I
DRESDEN, , D-01307
Germany
Universitaetsklinik Goettingen
Gottingen, , D-37075
Germany
Universitaet Ulm
ULM, , D-89075
Germany
Zentralkrankenhaus
Bremen, , D-28205
Germany
Christian-Albrechts University of Kiel
Kiel, , D-24105
Germany
Dr. Hors t- Schmidt - Kliniken
Wiesbaden, , D-65199
Germany
Universitaetsklinikum Tuebingen
Tuebingen, , D-72076
Germany
Klinikum der J.W. Goethe Universitaet
Frankfurt, , 60596
Germany
Staedtisches Krankenhaus FFM-Hoechst
Frankfurt Am Main, , 65929
Germany
Evangelisches Krankenhaus
Dusseldorf, , DOH-40217
Germany
Universitaetsklinikum Charite
Berlin, , D-10117
Germany
Klinik und Poliklinik fuer Kinderheilkunde
Muenster, , D-48129
Germany
Klinikum Grosshadern
Munich (Muenchen), , D-81377
Germany
Klinik der Otto - v. - Guericke - Universitat
Magdeburg, , 39108
Germany
Additional Information:
Study ID Numbers: CDR0000069262; EU-20147,AGOSG-AGO-GYN-2
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00032162
Other Cervical Cancer Studies:
1. Temozolomide and Thalidomide in Treating Patients With Metastatic, Locally Advanced, or Unresectable Leiomyosarcoma
2. Surgery With or Without Combination Chemotherapy in Treating Patients With Lung Metastases From Soft Tissue Sarcoma
3. Thalidomide in Treating Patients With Gynecologic Sarcomas
4. Surgery With or Without Chemotherapy in Treating Patients With Soft Tissue Sarcoma
5. Gemcitabine, Docetaxel, and Filgrastim in Treating Patients With Recurrent or Persistent Leiomyosarcoma or Soft Tissue Sarcoma
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Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer
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