Study of Paclitaxel in Patients With Ovarian Cancer

Inclusion Criteria:

• Histological or cytological confirmed epithelial ovarian cancer, primary peritonealcancer or fallopian tube cancer.

• Patients relapsing > 6 months after end of first line or second line treatmentincluding platinum based therapy. Prior therapy and duration of response will bedocumented in the CRF for descriptive analysis.

• CA 125 >2 x upper normal limit (UNL) documented at two occasions, with more than oneweek interval, according to appendix I, patient groups A and B, measurable/non-measurable disease.

• 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

Exclusion Criteria:

• 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-125measurements

• Patient receiving concurrent hormonal, immuno-, or radiotherapy. Treatment must havestopped 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 pregnantor 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 wouldpreclude 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 toparticipate in the study

• Participation in an investigational drug study within 4 weeks prior to study treatment (Day 1, Cycle 1)