Study of Paclitaxel in Patients With Ovarian Cancer 

Tracking Information

Start Date  ICMJEFebruary 2009
Estimated Primary Completion DateMarch 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2009)
  • Progression free survival (PFS). [ Time Frame: End of the study (month 12) ] [ Designated as safety issue: No ]
  • Incidence and severity of hypersensitivity reactions [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00989131 on Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: October 1, 2009)
  • Nadir and time to nadir of CA 125 during and after treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • T½ of CA 125 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Response rate using CA 125 [ Time Frame: 12 month ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEStudy of Paclitaxel in Patients With Ovarian Cancer
Official Title  ICMJEAn 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)
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®.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJE
  • Epithelial Ovarian Cancer
  • Primary Peritoneal Cancer
  • Fallopian Tube Cancer
Intervention  ICMJE
  • Drug: Paclical®

    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.

  • Drug: Taxol®

    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.

Study Arms / Comparison Groups
  • Paclitaxel, micellar (Paclical®): Experimental
    Intervention: Drug: Paclical®
  • Paclitaxel, CrEL (Taxol®): Active Comparator
    Intervention: Drug: Taxol®

Recruitment Information

Estimated Enrollment  ICMJE650
Estimated Completion DateMay 2011
Estimated Primary Completion DateMarch 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Margareta Eriksson, Clinical Trial Manager+46 18 56 96
Location Countries  ICMJEBelarus,   Belgium,   Bulgaria,   Croatia,   Czech Republic,   Denmark,   Finland,   Hungary,   Latvia,   Lithuania,   Romania,   Russian Federation,   Serbia,   Slovakia,   Sweden,   Ukraine

Administrative Information

Responsible PartyClinical trial manager, Oasmia Pharmaceutical AB
Study ID Numbers  ICMJEOAS-07OVA
Study Sponsor  ICMJEOasmia Pharmaceutical AB
Collaborators  ICMJEOrion Corporation, Orion Pharma
Investigators  ICMJE
Principal Investigator:Ignace Vergote, Prof.Division of Gynaecological Oncology, Department of Obstetrics and Gynaecology, University Hospitals Leuven, Belgium
Information Provided ByOasmia Pharmaceutical AB