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	Treatment or Intervention	Phase
Cervical Cancer Endometrial Cancer Fallopian Tube Cancer uterine sarcoma ovarian sarcoma ovarian carcinosarcoma	Drug: carboplatin  Drug: doxorubicin HCl liposome  Procedure: chemotherapy	Phase I Phase II

Further Study 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Germany
      Christian-Albrechts University of Kiel, Kiel,  D-24105,  Germany
      Dr. Hors t- Schmidt - Kliniken, Wiesbaden,  D-65199,  Germany
      Evangelisches Krankenhaus, Dusseldorf,  DOH-40217,  Germany
      Frauenklinik der MHH, Hannover,  30659,  Germany
      Klinik der Otto - v. - Guericke - Universitat, Magdeburg,  39108,  Germany
      Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet, Greifswald,  D-17487,  Germany
      Klinik und Poliklinik fuer Kinderheilkunde, Muenster,  D-48129,  Germany
      Klinikum der J.W. Goethe Universitaet, Frankfurt,  60596,  Germany
      Klinikum Grosshadern, Munich (Muenchen),  D-81377,  Germany
      Klinikum Rechts Der Isar/Technische Universitaet Muenchen, Munich (Muenchen),  D-81675,  Germany
      Medizinische Klinik I, Dresden,  D-01307,  Germany
      Staedtisches Krankenhaus FFM-Hoechst, Frankfurt am Main,  65929,  Germany
      Universitaet Ulm, Ulm,  D-89075,  Germany
      Universitaetsklinik Duesseldorf, Duesseldorf,  D-40225,  Germany
      Universitaetsklinik Goettingen, Gottingen,  D-37075,  Germany
      Universitaetsklinikum Charite, Berlin,  D-10117,  Germany
      Universitaetsklinikum Tuebingen, Tuebingen,  D-72076,  Germany
      Vincentius Krankenhaus, Karlsruhe,  D-76137,  Germany
      Zentralkrankenhaus, Bremen,  D-28205,  Germany

Study chairs or principal investigators

Andreas du Bois, MD, PhD,  Study Chair,  Dr. Hors t- Schmidt - Kliniken   

Study ID Numbers:  CDR0000069262; AGOSG-AGO-GYN-2; EU-20147
Record last reviewed:  March 2003
Last Updated:  October 13, 2004
Record first received:  March 8, 2002
ClinicalTrials.gov Identifier:  NCT00032162
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08