Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
Conditions
Keywords
Ovarian Cancer
Brief summary
RATIONALE: Paclitaxel is one of the most widely used human anticancer agents. Paclitaxel has a low degree of solubility and Cremophor EL is typically used as the solubiliser. Cremophor EL is known to cause hypersensitivity reactions that can be life-threatening. As Paclical® does not contain Cremophor EL, hypersensitivity reactions can be expected to be less. PURPOSE: To study the efficay and safety of two different formulations of paclitaxel, Paclical® and Taxol®.
Interventions
DRUGPaclical®
250 mg/m2 of Paclical® is given as a one-hour IV infusion, followed by carboplatin, on day 1 of each 21 day cycle. Number of Cycles: 6. Cycle 2-6 will be given with 3 weeks interval between treatments.
DRUGTaxol®
175 mg/m2 of Taxol® is given as 3 hour IV infusion, followed by carboplatin on day 1 of each 21 day cycle. Number of Cycles: 6. Cycle 2-6 will be given with 3 weeks interval between treatments.
Sponsors
Oasmia Pharmaceutical AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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) * 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-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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS). | — |
| Change in Area under the curve of CA 125 | — |
| Incidence and severity of hypersensitivity reactions | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate using CA 125 | — |
| Nadir and time to nadir of CA 125 during and after treatment | — |
| Overall survival | — |
| T½ of CA 125 | — |
| Safety and tolerability | — |
Countries
Belarus, Belgium, Bulgaria, Croatia, Czechia, Denmark, Finland, Hungary, Latvia, Lithuania, Romania, Russia, Serbia, Slovakia, Sweden, Ukraine
Outcome results
None listed