Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Oasmia Pharmaceutical AB
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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- 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)
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
You may not be if
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 measurements
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)
