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| Sponsor: | AGO Ovarian Cancer Study Group |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00032162 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cervical Cancer Endometrial Cancer Fallopian Tube Cancer Ovarian Cancer Sarcoma |
Drug: carboplatin Drug: pegylated liposomal doxorubicin hydrochloride |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase I/II Trial, Dose Finding Combination Chemotherapy With PegLiposomal Doxorubicin (PLD) And Carboplatin In Patients With Gynecologic Tumors |
| Study Start Date: | August 2001 |
OBJECTIVES:
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed fallopian tube cancer, Muellerian mixed tumor, endometrial cancer, uterine sarcoma, ovarian cancer with sarcoma parts, or cervical cancer
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| Germany | |
| Christian-Albrechts University of Kiel | |
| Kiel, Germany, D-24105 | |
| Dr. Hors t- Schmidt - Kliniken | |
| Wiesbaden, Germany, D-65199 | |
| Evangelisches Krankenhaus | |
| Dusseldorf, Germany, DOH-40217 | |
| Frauenklinik der MHH | |
| Hannover, Germany, 30659 | |
| Klinik der Otto - v. - Guericke - Universitat | |
| Magdeburg, Germany, 39108 | |
| Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet | |
| Greifswald, Germany, D-17487 | |
| Klinik und Poliklinik fuer Kinderheilkunde | |
| Muenster, Germany, D-48129 | |
| Klinikum der J.W. Goethe Universitaet | |
| Frankfurt, Germany, 60596 | |
| Klinikum Grosshadern | |
| Munich (Muenchen), Germany, D-81377 | |
| Zentralkrankenhaus | |
| Bremen, Germany, D-28205 | |
| Medizinische Klinik I | |
| Dresden, Germany, D-01307 | |
| Staedtisches Krankenhaus FFM-Hoechst | |
| Frankfurt Am Main, Germany, 65929 | |
| Universitaet Ulm | |
| Ulm, Germany, D-89075 | |
| Universitaetsklinik Duesseldorf | |
| Duesseldorf, Germany, D-40225 | |
| Universitaetsklinik Goettingen | |
| Gottingen, Germany, D-37075 | |
| Universitaetsklinikum Charite | |
| Berlin, Germany, D-10117 | |
| Universitaetsklinikum Tuebingen | |
| Tuebingen, Germany, D-72076 | |
| Vincentius Krankenhaus | |
| Karlsruhe, Germany, D-76137 | |
| Klinikum Rechts Der Isar/Technische Universitaet Muenchen | |
| Munich (Muenchen), Germany, D-81675 | |
| Study Chair: | Andreas du Bois, MD, PhD | Dr. Horst-Schmidt-Kliniken |
More Information
| Study ID Numbers: | CDR0000069262, AGOSG-AGO-GYN-2, EU-20147 |
| Study First Received: | March 8, 2002 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00032162 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
|
Gonadal Disorders Antineoplastic Agents Urogenital Neoplasms Ovarian Diseases Antibiotics, Antineoplastic Genital Diseases, Female Neoplasms, Connective and Soft Tissue Endometrial Neoplasms Neoplasms by Site Therapeutic Uses Uterine Neoplasms Endocrine Gland Neoplasms Ovarian Neoplasms |
Neoplasms by Histologic Type Genital Neoplasms, Female Endocrine System Diseases Uterine Diseases Carboplatin Fallopian Tube Neoplasms Doxorubicin Pharmacologic Actions Adnexal Diseases Fallopian Tube Diseases Neoplasms Sarcoma |