A Non Interventional Study With Paclitaxel Onkovis (Paclitaxel) Utilized for the Treatment of Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Onkovis GmbH
Sponsor:
Collaborator:
AKP Freiburg GmbH
Information provided by (Responsible Party):
Onkovis GmbH
ClinicalTrials.gov Identifier:
NCT01668108
First received: August 15, 2012
Last updated: February 5, 2014
Last verified: September 2013
  Purpose

The main purpose of this observational study with Paclitaxel is to determine the number of treatment cycles and the quantity of Paclitaxel onkovis needed therefore under the special circumstance of ambulant chemotherapy.

onkovis aims an economical utilization of the chemotherapeutics.The provision with adapted packaging sizes as to decrease the excess quantity to be discarded follows also this objective.

Secondary objectives are the survey of the side effects of Paclitaxel onkovis in comparison to Docetaxel. To this purpose, data regarding co medications and adverse events are also collected.


Condition
Carcinoma

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Open, Multicenter Observational Study of Paclitaxel Utilized in Mono- or Combination Therapy for the Treatment of Breast Cancer, Non-small Cell Lung Cancer and Ovarial Cancer.

Resource links provided by NLM:


Further study details as provided by Onkovis GmbH:

Primary Outcome Measures:
  • the quantity of Paclitaxel onkovis needed pro treatment cycle [ Time Frame: the time the participants will be followed depends on the number of treatment cycles; that means the time frame may extend up to 24 weeks (8 cycles). ] [ Designated as safety issue: No ]
    Determine the quantity of Paclitaxel onkovis needed pro treatment cycle


Secondary Outcome Measures:
  • adverse events during and after treatment in comparison to Docetaxel onkovis [ Time Frame: up to 24 weeks (8 cycles) ] [ Designated as safety issue: Yes ]
    The number and kind of adverse events during and after the intra-venous application of Paclitaxel will be assessed, documented and compared to those of Docetaxel.


Estimated Enrollment: 250
Study Start Date: August 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
carcinoma, Paclitaxel onkovis (Paclitaxel)
treatment in mono- or combination therapy with Paclitaxel of breast-, non-small cell lung- and ovarial cancer.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients treated in practices, clinics, hospitals

Criteria

Inclusion Criteria:

  • Indication for Paclitaxel according to the SmPC and treating physician

Exclusion Criteria:

  • according to the Paclitaxel SmPC
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01668108

Contacts
Contact: K.-U. Seiler, PD Dr. med. +49(0)761479400 info@akp-freiburg.de

Locations
Germany
Practice Recruiting
Brandenburg, Germany, 14770
Practice Recruiting
Chemnitz, Germany, 09117
Practice Recruiting
Dresden, Germany, 01307
Practice Recruiting
Mühlhausen, Germany, 99974
Practice Recruiting
Plauen, Germany, 08525
Sponsors and Collaborators
Onkovis GmbH
AKP Freiburg GmbH
  More Information

No publications provided

Responsible Party: Onkovis GmbH
ClinicalTrials.gov Identifier: NCT01668108     History of Changes
Other Study ID Numbers: ONKOPAC 01
Study First Received: August 15, 2012
Last Updated: February 5, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Onkovis GmbH:
carcinoma
breast cancer
non-small cell lung cancer
ovarial cancer
ambulant chemotherapy
treatment cycles
Paclitaxel
Paclitaxel onkovis
Quantity of Paclitaxel
Packaging Sizes

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014