Status:
COMPLETED
Study of Paclitaxel in Patients With Ovarian Cancer
Lead Sponsor:
Oasmia Pharmaceutical AB
Conditions:
Epithelial Ovarian Cancer
Primary Peritoneal Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
789 Patients enrolled
Trial Details
Trial ID
NCT00989131
Start Date
February 1 2009
End Date
October 1 2013
Last Update
February 4 2014
Active Locations (84)
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1
Gomel Regional Clincial Oncology Center
Homyel, Belarus, 246012
2
Minsk City Clinical Oncology Hospital
Minsk, Belarus, 220013
3
Alexandrov National Cancer Center of Belarus
Minsk, Belarus, 223040
4
Vitebsk Regional Clinical Oncology Center
Vitebsk, Belarus, 210603