Know Cancer

forgot password

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

Phase 2
18 Years
Not Enrolling
Cancer of the Ovary Treated as 2nd Line Therapy, Muellerian Mixed Tumours, Tumours of the Uterus, Cervical Cancers, Non-Epithelial Ovarian Tumours

Thank you

Trial Information

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

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

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

- 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

Type of Study:


Study Design:

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

Outcome Measure:


Principal Investigator

Andreas du Bois, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

AGO-OVAR, AGO Ovarian Cancer Study Group


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

June 2003

Completion Date:

September 2006

Related Keywords:

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