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Study of Paclitaxel in Patients With Ovarian Cancer

NCT00989131 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 789

Last updated 2014-02-04

No results posted yet for this study

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®.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Oasmia Pharmaceutical AB

    lead INDUSTRY

Principal Investigators

  • Ignace Vergote, Prof. · Division of Gynaecological Oncology, Department of Obstetrics and Gynaecology, University Hospitals Leuven, Belgium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Belarus
  • Belgium
  • Bulgaria
  • Croatia
  • Czechia
  • Denmark
  • Finland
  • Hungary
  • Latvia
  • Lithuania
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • Sweden
  • Ukraine

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00989131 on ClinicalTrials.gov