NCT00032162

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2002

Completed
11 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Last Updated

May 31, 2012

Status Verified

May 1, 2012

Enrollment Period

3.8 years

First QC Date

March 8, 2002

Last Update Submit

May 29, 2012

Conditions

Cervical CancerEndometrial CancerFallopian Tube CancerOvarian CancerSarcoma

Keywords

stage III cervical cancerrecurrent cervical cancerstage IB cervical cancerstage IIB cervical cancerstage IVB cervical cancerstage IA cervical cancerstage IIA cervical cancerstage IVA cervical cancerstage I endometrial carcinomastage II endometrial carcinomastage III endometrial carcinomastage IV endometrial carcinomarecurrent endometrial carcinomafallopian tube cancerstage I uterine sarcomastage II uterine sarcomastage III uterine sarcomastage IV uterine sarcomarecurrent uterine sarcomaovarian sarcomaovarian carcinosarcoma

Outcome Measures

Primary Outcomes (1)

  • DL DLT

    DLT during first 3 cycles

Study Arms (1)

PLD

EXPERIMENTAL

dose finding study of PLD in combination with Carboplatin

Drug: carboplatinDrug: pegylated liposomal doxorubicin hydrochloride

Interventions

carboplatinDRUG

AUC 6 q4w

PLD
pegylated liposomal doxorubicin hydrochlorideDRUG

20/30/40 mg/qm q4w Dose finding study

PLD

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (19)

Universitaetsklinikum Charite

Berlin, D-10117, Germany

Location

Zentralkrankenhaus

Bremen, D-28205, Germany

Location

Medizinische Klinik I

Dresden, D-01307, Germany

Location

Universitaetsklinik Duesseldorf

Düsseldorf, D-40225, Germany

Location

Evangelisches Krankenhaus

Düsseldorf, DOH-40217, Germany

Location

Klinikum der J.W. Goethe Universitaet

Frankfurt, 60596, Germany

Location

Staedtisches Krankenhaus FFM-Hoechst

Frankfurt am Main, 65929, Germany

Location

Universitaetsklinik Goettingen

Göttingen, D-37075, Germany

Location

Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet

Greifswald, D-17487, Germany

Location

Frauenklinik der MHH

Hanover, 30659, Germany

Location

Vincentius Krankenhaus

Karlsruhe, D-76137, Germany

Location

Christian-Albrechts University of Kiel

Kiel, D-24105, Germany

Location

Klinik der Otto - v. - Guericke - Universitat

Magdeburg, 39108, Germany

Location

Klinikum Grosshadern

Munich (Muenchen), D-81377, Germany

Location

Klinikum Rechts Der Isar/Technische Universitaet Muenchen

Munich (Muenchen), D-81675, Germany

Location

Klinik und Poliklinik fuer Kinderheilkunde

Münster, D-48129, Germany

Location

Universitaetsklinikum Tuebingen

Tübingen, D-72076, Germany

Location

Universitaet Ulm

Ulm, D-89075, Germany

Location

Dr. Hors t- Schmidt - Kliniken

Wiesbaden, D-65199, Germany

Location

Related Publications (1)

  • du Bois A, Pfisterer J, Burchardi N, Loibl S, Huober J, Wimberger P, Burges A, Stahle A, Jackisch C, Kolbl H; Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom; Kommission Uterus. Combination therapy with pegylated liposomal doxorubicin and carboplatin in gynecologic malignancies: a prospective phase II study of the Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom (AGO-OVAR) and Kommission Uterus (AGO-K-Ut). Gynecol Oncol. 2007 Dec;107(3):518-25. doi: 10.1016/j.ygyno.2007.08.008. Epub 2007 Oct 25.

    PMID: 17910981RESULT

MeSH Terms

Conditions

Uterine Cervical NeoplasmsEndometrial NeoplasmsFallopian Tube NeoplasmsOvarian NeoplasmsSarcoma

Interventions

Carboplatin

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesFallopian Tube DiseasesAdnexal DiseasesEndocrine Gland NeoplasmsOvarian DiseasesEndocrine System DiseasesGonadal DisordersNeoplasms, Connective and Soft TissueNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Study Officials

  • Andreas du Bois, MD, PhD

    Dr. Horst-Schmidt-Kliniken

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2002

First Posted

January 27, 2003

Study Start

August 1, 2001

Primary Completion

May 1, 2005

Last Updated

May 31, 2012

Record last verified: 2012-05

Locations

DE(19)