platinum-refractory and platinum-resistant epithelial cancer of the ovary, fallopian tube, and the peritoneum
Conditions
Sponsors
Studienzentrale AGO Austria
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologically confirmed epithelial cancer of the ovary, the fallopian tube or the primary peritoneum. • Patients must have received first-line platinum-based chemotherapy. • Progression or recurrence during first-line platinum-based chemotherapy (= platinum-refractory disease) or progression/recurrence during the first 6 months following the end of the last platinum-containing chemotherapy (= day 21 or day 28) = platinum-resistant disease. • Age ? 18 years. • Karnofsky performance status > 70. • Life expectancy > 3 months. • Measurable metastatic disease on CT or MRI or ultrasound, or chest X-ray and/or • Evaluable disease on CT/MRI (e.g. ascites, pleural effusion) or chest X-ray (e.g. pleural effusion) and/or • Tumor marker progression (CA-125) according to the criteria by Rustin. Increasing CA-125 levels according to Rustin et al. ( ): CA-125 > 2x UNL (upper normal limit) or CA-125 > 2x nadir value on two occasions. The date of progressive disease is defined as the first date of the CA-125 elevation to > 2x UNL or > 2x nadir value. • Normal organ functions: ? Adequate bone marrow function as indicated by: ? Platelets ? 100,000/mm3 ? Hemoglobin > 10 g/dL ? Neutrophils > 1.5 x 103/mm3 ? Adequate renal function as indicated by: ? Serum Creatinine 50% in an echocardiography or MUGA Scan within 28 days of study start. • Written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients with childbearing capacity. • Ovarian carcinosarcoma (malignant mixed Müllerian tumor) or pure sarcoma. • Any known hypersensitivity to study drugs. • Previous chemotherapy with PEG-liposomal doxorubicin (Caelyx) or Gemzar®.. • Significant comorbidity as e.g., uncontrolled infection, clinical signs of cardiac insufficiency, history of myocardial infarction or cardiac rhythmic disorders according to the NYHA classification LOWN > 2. • Any condition (medical, social, psychological), which would prevent adequate follow-up. • Active secondary malignant tumor diagnosed < 5 years (e.g. metastases from primary breast cancer).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess, if the response rate for the combination of liposomal-encapsulated doxorubicin citrate (Myocet®) and gemcitabine is favourable over single agent cytotoxic therapy with liposomal-encapsulated doxorubicin citrate (Myocet®);Secondary Objective: quality of life (EORTC-QLQ30 + QLQ-OV28) Progression-free survival Toxicity Overall survival ;Primary end point(s): Response rate | — |
Countries
Austria
Outcome results
None listed