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Study of Paclitaxel in Patients With Ovarian Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oasmia Pharmaceutical AB
ClinicalTrials.gov Identifier:
NCT00989131
First received: September 28, 2009
Last updated: February 3, 2014
Last verified: February 2014

September 28, 2009
February 3, 2014
February 2009
October 2013   (final data collection date for primary outcome measure)
  • Progression free survival (PFS). [ Designated as safety issue: No ]
  • Change in Area under the curve of CA 125
  • Incidence and severity of hypersensitivity reactions
  • 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 ]
Complete list of historical versions of study NCT00989131 on ClinicalTrials.gov Archive Site
  • Nadir and time to nadir of CA 125 during and after treatment [ Designated as safety issue: No ]
  • T½ of CA 125 [ Designated as safety issue: No ]
  • Safety and tolerability [ Designated as safety issue: Yes ]
  • Response rate using CA 125 [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
Study of Paclitaxel in Patients With Ovarian Cancer
An 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)

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®.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Epithelial Ovarian Cancer
  • Primary Peritoneal Cancer
  • Fallopian Tube Cancer
  • 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.

  • Experimental: Paclitaxel, micellar (Paclical®)
    Intervention: Drug: Paclical®
  • Active Comparator: Paclitaxel, CrEL (Taxol®)
    Intervention: Drug: Taxol®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
789
October 2013
October 2013   (final data collection date for primary outcome measure)

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)
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belarus,   Belgium,   Bulgaria,   Croatia,   Czech Republic,   Denmark,   Finland,   Hungary,   Latvia,   Lithuania,   Romania,   Russian Federation,   Serbia,   Slovakia,   Sweden,   Ukraine
 
NCT00989131
OAS-07OVA
Yes
Oasmia Pharmaceutical AB
Oasmia Pharmaceutical AB
Not Provided
Principal Investigator: Ignace Vergote, Prof. Division of Gynaecological Oncology, Department of Obstetrics and Gynaecology, University Hospitals Leuven, Belgium
Oasmia Pharmaceutical AB
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP