An Open, Randomized, Multicenter Study in Patients With Recurrent Epithelian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer to Compare the Efficay and Safety of Paclitaxel (Micellar) Nanoparticles and Paclitaxel (Cremophor® EL)
- Histological or cytological confirmed epithelial ovarian cancer, primary peritoneal
cancer or fallopian tube cancer.
- Patients relapsing > 6 months after end of first line or second line treatment
including platinum based therapy. Prior therapy and duration of response will be
documented in the CRF for descriptive analysis.
- CA 125 >2 x upper normal limit (UNL) documented at two occasions, with more than one
week interval, according to appendix I, patient groups A and B, measurable/non-
- Age > 18 years
- Eastern Cooperative Oncology Group (ECOG) performance score 0-2
- Life expectancy >12 weeks
- Patient has blood counts at baseline of:
- Absolute neutrophil count (ANC) >1,5 x 109 / L.
- Platelet count >100 x 109 / L
- Haemoglobin (Hb) ≥9g/dl (can be post transfusion)
- Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) < 2 x UNL
- Total bilirubin ≤1.5 x UNL.
- Adequate renal function defined as serum creatinine < 2.0 mg/dl or 177μmol/l.
- Alkaline phosphatase (ALP) < 2.5 x UNL
- Signed informed consent obtained
- Patient has peripheral neuropathy of grade ≥ 2 per NCI-CTCAE version 3.0
- Surgical procedure due to progressive disease within 4 weeks of any of the CA-125
- Patient receiving concurrent hormonal, immuno-, or radiotherapy. Treatment must have
stopped for at least 4 weeks before start of drug treatment (Day 1, Cycle 1).
- Bowel obstruction at screening
- Tumours of other origin or histology
- Patient of child-bearing potential, not practising adequate contraception, or
pregnant or lactating women
- Patient has a history of severe allergy or severe hypersensitivity to study drugs
- Any uncontrolled medical problem that in the opinion of the investigator would
preclude safe administration of the study drugs, e.g. heart, lung or kidney disease,
suspicion of brain metastasis or mental disorder to make the patient unable to
participate in the study
- Participation in an investigational drug study within 4 weeks prior to study
treatment (Day 1, Cycle 1)