Combination Chemotherapy Consisting of Pegylated Liposomal Doxorubicin and Carboplatin in Malignant Gynecologic Tumours

Cervical Cancers Clinical Trial

Official title:

Phase II Trial With Combination Chemotherapy Consisting of Pegylated Liposomal Doxorubicin (PLD) and Carboplatin in Malignant Gynecologic Tumour's

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00189410
• Other study ID #: AGO-GYN 3
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: July 19, 2010
• Start date: June 2003
• Est. completion date: September 2006

Study information

• Verified date: July 2010
• Source: AGO Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Description:

Aim of these study is the evaluation of combination chemotherapy in a patient subset with gynecologic tumours on regard to tolerance and efficacy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: September 2006
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer of the Ovary Treated as 2nd Line Therapy
• Cervical Cancers
• Genital Neoplasms, Female
• Muellerian Mixed Tumours
• Neoplasms
• Non-Epithelial Ovarian Tumours
• Ovarian Neoplasms
• Tumours of the Uterus
• Uterine Cervical Neoplasms
• Uterine Neoplasms

Intervention

Drug:
• Pegylated Liposomal Doxorubicin and Carboplatin

Locations

Country	Name	City	State
Germany	Medical Practice Dr. Klare	Berlin
Germany	Evangelisches Krankenhaus, Dept. of Gynecology & Obstetrics	Duesseldorf
Germany	Univerisity Hospital; Dept. of Gynecology & Obstetrics	Erlangen
Germany	University hospital, Dept. of gynecology & obstetrics	Essen
Germany	University hospital , Dept. gynecologic & obestretics	Frankfurt
Germany	University of Freiburg; Dept of Gynecology & Obstetrics	Freiburg
Germany	Ernst-Moritz-Arndt University, Dept. of Gynecology & Obstetrics	Greifswald
Germany	MH Hannover, Dept. of Gynecology & Obstetrics	Hannover
Germany	St. Vincentius Hospital, Dept. of Gynecology & Obstetrics	Karlsruhe
Germany	Univerisity Clinic Schleswig-Holstein, Campus Kiel, Dept. for gynecology & obstetrics	Kiel
Germany	Otto-von-Guericke Univerisity, Dept. of Gynecology & Obstetrics	Magdeburg
Germany	University hospital, Dept. of Gynecology & Obstetrics	Mainz
Germany	Phillips University, Clinic fo gynecology, gyn endocrinology and oncology	Marburg
Germany	University hospital Muenchen-Grosshadern, Dept. of gynecology & obstetrics	Muenchen
Germany	University Hospital TU Muenchen; Dept. of Gynecology & Obstetrics	Muenchen
Germany	Humaine Vogtlandklinikum; Dept. of gynecology & obstetrics	Plauen
Germany	University hospital, Dept. gynecology & obstetrics	Tuebingen
Germany	Schwarzwald-Baar Klinikum Villingen, Dept. Gynecology	Villingen-Schwenningen
Germany	HSK, Dr. Horst Schmidt Klinik, Dept. of Gynecology & Gyn. Oncology	Wiesbaden

Sponsors (3)

Lead Sponsor	Collaborator
AGO Study Group	Essex Pharma GmbH, MedServ. GmbH, Wiesbaden

Country where clinical trial is conducted

Germany, 

References & 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerance
Primary	Response Rate mainly in malignant uterine tumours
Secondary	Time to Progression mainly in malignant uterine tumours
Secondary	Overall Survival mainly in malignant uterine tumours

External Links

•   Homepage of the AGO Ovarian Cancer Study Group