NCT00189410

Brief Summary

Pegylated Liposomal Doxorubicin as well as Carboplatin have been showed efficacy in monotherapy as in combination therapy of gynaecologic tumours. As there is no common standard in the therapy of recurrent ovarian carcinoma, tumours of the uterus nor for non-epithelial ovarian tumours at time of designing of this study, this trial shall evaluate the new and well tolerated combination therapy consisting of Pegylated Liposomal Doxorubicin and Carboplatin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2003

Typical duration for phase_2

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

June 1, 2003

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

July 20, 2010

Status Verified

July 1, 2010

Enrollment Period

2.3 years

First QC Date

September 12, 2005

Last Update Submit

July 19, 2010

Conditions

Cancer of the Ovary Treated as 2nd Line TherapyMuellerian Mixed TumoursTumours of the UterusCervical CancersNon-Epithelial Ovarian Tumours

Outcome Measures

Primary Outcomes (2)

  • Tolerance

  • Response Rate mainly in malignant uterine tumours

Secondary Outcomes (2)

  • Time to Progression mainly in malignant uterine tumours

  • Overall Survival mainly in malignant uterine tumours

Interventions

Pegylated Liposomal Doxorubicin and CarboplatinDRUG

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed diagnosis of a gynecologic tumour \[(non-epithelial ovarian tumour without germcell-tumours, tumours of the uterus (eg. Muellerian mixed tumours, Endometrial carcinomas, Uterus sarcoma, Cancer of the cervix)\]
  • Target or non-target lesion. Patients with epithelial ovarian carcinoma are qualified also if they have a CA 125 increase only.
  • Patients with ovarian carcinoma must have completed a platin-containing chemotherapy more than 6 months at least. Patients with other malignancies could have prior chemotherapy, but must'nt
  • Prior Radiotherapy less than 25% of haemapoietic system is allowed, but should have completed at least 6 weeks prior or registration
  • Prior antitumoral hormone therapy, or specific immunotherapy is allowed, treatment have to be completed at least 3 weeks prior of registration
  • All women with childbearing potential have to be a negative pregnancy test within 7 days of registration
  • Perfomance Status 0-2 ECOG or more than 60% according to Karnofsky Index
  • Estimated expectancy of life of more than 12 weeks
  • adequate hematologic, renal and hepatic function according to following definitions: absolute Neutrophils \>= 1,5 n/L Platelets \>= 100 n/L Bilirubine \<= 1,25 x ULN estimated glomerular filtration rate (Jelliffe) \>= 60 ml/min
  • Patients who have given their signed and written informed consent to participate in the trial
  • Patients must be geographically accessible for treatment and follow

You may not qualify if:

  • More than 2 prior chemotherapies (or Radio-Chemotherapies)
  • active infection or concurrent severe medical problems unrelated to malignancy which would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy
  • application of other cytotoxic or antitumoral agents during study period
  • Patients with a history of seizure disorder or central nervous system disorders
  • History of congestive heart failure (NYHA Classification \> 2, even if medically controlled.
  • History of clinical and electrocardiographically documented myocardial infarction within the last 6 months.
  • History of atrial or ventricular arrhythmias (\> LOWN II)
  • Women who are pregnant or breast feeding
  • Fertile women not using adequate contraceptive measures
  • Patients who have used any investigational drugs within 30 days of study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Medical Practice Dr. Klare

Berlin, 10367, Germany

Location

Evangelisches Krankenhaus, Dept. of Gynecology & Obstetrics

Düsseldorf, 40217, Germany

Location

Univerisity Hospital; Dept. of Gynecology & Obstetrics

Erlangen, 91054, Germany

Location

University hospital, Dept. of gynecology & obstetrics

Essen, 45122, Germany

Location

University hospital , Dept. gynecologic & obestretics

Frankfurt, 60596, Germany

Location

University of Freiburg; Dept of Gynecology & Obstetrics

Freiburg im Breisgau, 79106, Germany

Location

Ernst-Moritz-Arndt University, Dept. of Gynecology & Obstetrics

Greifswald, 17487, Germany

Location

MH Hannover, Dept. of Gynecology & Obstetrics

Hanover, 30625, Germany

Location

St. Vincentius Hospital, Dept. of Gynecology & Obstetrics

Karlsruhe, 76137, Germany

Location

Univerisity Clinic Schleswig-Holstein, Campus Kiel, Dept. for gynecology & obstetrics

Kiel, 24105, Germany

Location

Otto-von-Guericke Univerisity, Dept. of Gynecology & Obstetrics

Magdeburg, 39108, Germany

Location

University hospital, Dept. of Gynecology & Obstetrics

Mainz, 55101, Germany

Location

Phillips University, Clinic fo gynecology, gyn endocrinology and oncology

Marburg, 35033, Germany

Location

University hospital Muenchen-Grosshadern, Dept. of gynecology & obstetrics

München, 81377, Germany

Location

University Hospital TU Muenchen; Dept. of Gynecology & Obstetrics

München, 81675, Germany

Location

Humaine Vogtlandklinikum; Dept. of gynecology & obstetrics

Plauen, 08529, Germany

Location

University hospital, Dept. gynecology & obstetrics

Tübingen, 72076, Germany

Location

Schwarzwald-Baar Klinikum Villingen, Dept. Gynecology

Villingen-Schwenningen, 78050, Germany

Location

HSK, Dr. Horst Schmidt Klinik, Dept. of Gynecology & Gyn. Oncology

Wiesbaden, D-65199, Germany

Location

Related Publications (1)

  • Gropp M, du Bois A, Burges A, Meier W. Combination of Pegliposomal Doxorubicin (PLD) and Carboplatin in gynecologic tumors - An AGO Study Group Phase I/II trial. Int J Gycecol Cancer 2003:13 Suppl 1, p 112

    BACKGROUND

Related Links

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

liposomal doxorubicinCarboplatin

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Study Officials

  • Andreas du Bois, MD PhD

    AGO-OVAR, AGO Ovarian Cancer Study Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

June 1, 2003

Primary Completion

September 1, 2005

Study Completion

September 1, 2006

Last Updated

July 20, 2010

Record last verified: 2010-07

Locations

DE(19)