Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer
Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer
About this trial
This is an interventional treatment trial for Cervical Cancer focused on measuring stage III cervical cancer, recurrent cervical cancer, stage IB cervical cancer, stage IIB cervical cancer, stage IVB cervical cancer, stage IA cervical cancer, stage IIA cervical cancer, stage IVA cervical cancer, stage I endometrial carcinoma, stage II endometrial carcinoma, stage III endometrial carcinoma, stage IV endometrial carcinoma, recurrent endometrial carcinoma, fallopian tube cancer, stage I uterine sarcoma, stage II uterine sarcoma, stage III uterine sarcoma, stage IV uterine sarcoma, recurrent uterine sarcoma, ovarian sarcoma, ovarian carcinosarcoma
Eligibility 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
Sites / Locations
- Universitaetsklinikum Charite
- Zentralkrankenhaus
- Medizinische Klinik I
- Universitaetsklinik Duesseldorf
- Evangelisches Krankenhaus
- Staedtisches Krankenhaus FFM-Hoechst
- Klinikum der J.W. Goethe Universitaet
- Universitaetsklinik Goettingen
- Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet
- Frauenklinik der MHH
- Vincentius Krankenhaus
- Christian-Albrechts University of Kiel
- Klinik der Otto - v. - Guericke - Universitat
- Klinik und Poliklinik fuer Kinderheilkunde
- Klinikum Grosshadern
- Klinikum Rechts Der Isar/Technische Universitaet Muenchen
- Universitaetsklinikum Tuebingen
- Universitaet Ulm
- Dr. Hors t- Schmidt - Kliniken
Arms of the Study
Arm 1
Experimental
PLD
dose finding study of PLD in combination with Carboplatin