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

This study has been completed.
Sponsor:
Collaborator:
AKP Freiburg GmbH
Information provided by (Responsible Party):
Onkovis GmbH
ClinicalTrials.gov Identifier:
NCT01614002
First received: June 1, 2012
Last updated: June 3, 2015
Last verified: June 2015
  Purpose

The main purpose of this observational study with Docetaxel is to determine the number of treatment cycles and the quantity of Doce 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 evaluation of the safety and tolerability of Doce onkovis. 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 Docetaxel Utilized in Mono- or Combination Therapy for Treatment of Breast Cancer, NSCLC, Prostate Carcinoma, Adenocarcinoma of Stomach and Advanced Squamous Cell Carcinoma of Head/Neck Region.

Resource links provided by NLM:


Further study details as provided by Onkovis GmbH:

Primary Outcome Measures:
  • the quantity of Doce 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 Doce onkovis needed pro treatment cycle


Secondary Outcome Measures:
  • adverse events during and after treatment [ 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 Docetaxel will be assessed and documented.


Enrollment: 371
Study Start Date: May 2012
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
carcinoma, Doce onkovis (Docetaxel)
treatment in mono- or combination therapy with Docetaxel of breast cancer, non-small cell lung cancer, prostata carcinoma, adenocarcinoma of the stomach and advanced squamous cell carcinoma of the head/neck region.

  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 Docetaxel according to the SmPC and treating physician

Exclusion Criteria:

  • according to the Docetaxel 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: NCT01614002

Locations
Germany
Practice
Berlin, Germany, 13156
Practice
Brandenburg, Germany, 14770
Practice
Chemnitz, Germany, 09117
Practice
Cottbus, Germany, 03055
Practice
Dresden, Germany, 01307
Practice
Elstra, Germany, 01920
Practice
Freital, Germany, 01705
Practice
Fürstenwalde, Germany, 15517
Practice
Halle/Saale, Germany, 06132
Practice
Kronach, Germany, 96317
Practice
Köthen, Germany, 06366
Hospital
Leipzig, Germany, 04277
Practice
Leipzig, Germany, 04277
Practice
Magdeburg, Germany, 39104
Practice
Meiningen, Germany, 98617
Practice
Mühlhausen, Germany, 99974
Practice
Parchim, Germany, 19370
Practice
Plauen, Germany, 08525
Practice
Scheibenberg, Germany, 09481
Clinic
Torgau, Germany, 04860
Practice
Werdau, Germany, 08412
Practice
Zittau, Germany, 02763
Practice
Zwickau, Germany, 08060
Sponsors and Collaborators
Onkovis GmbH
AKP Freiburg GmbH
  More Information

No publications provided

Responsible Party: Onkovis GmbH
ClinicalTrials.gov Identifier: NCT01614002     History of Changes
Other Study ID Numbers: ONKODOC 01
Study First Received: June 1, 2012
Last Updated: June 3, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Onkovis GmbH:
carcinoma
breast cancer
non-small cell lung cancer
prostata cancer
adenocarcinoma of the stomach
squamous cell carcinoma of the head and neck region
ambulant chemotherapy
treatment cycles
Docetaxel
Doce onkovis
Quantity of Docetaxel
Packaging Sizes

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on August 27, 2015