Trial Condition(s):

Prostate Cancer, Ovarian Cancer

Prevention of Sagopilone-induced neurotoxicity with Acetyl-L-Carnitine (ALC)

Bayer Identifier:

91695

ClinicalTrials.gov Identifier:

NCT00751205

EudraCT Number:

2008-000879-26

Study Completed

Trial Purpose

This study investigates the safety and efficacy of Acetyl-L-Carnitine and compares it to the safety and efficacy of a placebo (inactive) tablet in the prevention of Sagopilone-induced peripheral neuropathy. Patients will receive intravenous infusion of sagopilone for 3 hours on day 1 of a 3-weeks cycle. Treatment with Sagopilone will be given as long as the patient is benefitting. In addition patients will receive ALC or placebo, starting 1 week before first sagopilone infusion and ending 30-33 days after the last infusion with sagopilone. Safety will be determined by laboratory and other evaluations. Efficacy of ALC will be determined by the incidence of all grades of peripheral neuropathy with the results of a patient questionnaire. Efficacy of the combination of ALC and Sagopilone will be determined by the tumor response.

Inclusion Criteria
- Males or females aged >/= 18 years
 - Epithelial ovarian, peritoneal cavity or Fallopian
tube cancer (except mucinous or clear cell 
tumors) or Adenocarcinoma of the prostate
 - At least 1 unidimensional  measurable lesion 
(suitable for RECIST evaluation) or for patients 
without measurable disease, CA 125 levels >/= 2  times the upper limit of normal (ULN) within 3
months and confirmed within 2 weeks prior to
first infusion (ovarian cancer) or PSA value >/= 5 ng/mL (HRPC). 
 - Progression of disease (HRPC) despite adequate androgen-inhibiting hormone therapy.  
 - Progression of disease (Ovarian Cancer) or 
symptomatic relapse after previous therapy
(elevated CA125 levels alone are insufficient for inclusion)  WHO performance status 0 to 1 
 - No clinical residual neuropathy (CTCAE Grade
0 at baseline)
 - Adequate recovery from previous surgery, 
radiation, and chemotherapy (excluding alopecia)
 - Adequate function of major organs and systems.
 - Survival expectation =3 months
 - Histologically or cytologically proven:
a) Epithelial ovarian, peritoneal cavity or Fallopian tube cancer (except mucionous cell tumors or clear cell tumors that have a clear cell component of >33%)
Exclusion Criteria
- Symptomatic brain metastases requiring whole-
brain irradiation 
 - Any concomitant malignancy: the following exceptions are allowed: Non-melanoma skin
cancer, Carcinoma in situ of the cervix, Malignancy with definitive treatment >/= 5 years ago without relapse.
 - Diabetes mellitus (even if controlled only by
special diet)
 - History of chronic hepatitis B or C, or known
 HIV infection 
 - Seizure disorder requiring medication (such as
steroids or anti-epileptics)
 - Inability to swallow oral medications
 - Prior treatment with epothilones
 - Concomitant use of neurotoxic drugs
 - Concomitant use of compounds that have
potentially positive effects towards symptoms
of neuropathy

Trial Summary

Enrollment Goal
150
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Sagopilone (BAY86-5302)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Klinikum der Eberhard-Karls-Universität Tübingen

Tübingen, Germany, 72076

Status
Completed
 
Locations

Universitätsklinikum Essen

Essen, Germany, 45122

Status
Completed
 
Locations

Klinikum Südstadt

Rostock, Germany, 18059

Status
Completed
 
Locations

Centre René Gauducheau

Nantes, France, 44805

Status
Completed
 
Locations

Centre René Gauducheau - Nantes

NANTES, France, 44805

Status
Completed
 
Locations

Diaconesses Croix Saint Simon - Paris

Paris, France, 75012

Status
Completed
 
Locations

Centre Val d'Aurelle - Montpellier

MONTPELLIER CEDEX, France, 34298

Status
Completed
 
Locations

IRST Istituto Scientifico Romagnolo per studio e cura Tumori

Meldola, Italy, 47014

Status
Completed
 
Locations

AUSL Rimini - Emilia Romagna

Rimini, Italy, 47900

Status
Completed
 
Locations

Academisch Ziekenhuis Maastricht

Maastricht, Netherlands, 6229 HX

Status
Completed
 
Locations

Vrije Universiteit Medisch Centrum

AMSTERDAM, Netherlands, 1081 HV

Status
Completed
 
Locations

Universitätsklinikum Essen

Essen, Germany, 45147

Status
Completed
 
Locations

Otto-von-Guericke-Universität Magdeburg

Magdeburg, Germany, 38108

Status
Completed
 
Locations

Medizinische Einrichtungen der Universität Bonn

Bonn, Germany, 53105

Status
Completed
 
Locations

Mount Vernon Hospital

Northwood, United Kingdom, HA6 2RN

Status
Completed
 
Locations

Leicester Royal Infirmary

Leicester, United Kingdom, LE1 5WW

Status
Completed
 
Locations

Centre Francois Baclesse

Caen, France, 14076

Status
Completed
 
Locations

Institut Gustave Roussy - Villejuif

VILLEJUIF, France, 94805

Status
Completed
 
Locations

A.O.U. di Bologna

Bologna, Italy, 40138

Status
Completed
 
Locations

A.O. Sant'Andrea

Roma, Italy, 00189

Status
Completed
 
Locations

CU Saint-Luc/UZ St-Luc

BRUXELLES - BRUSSEL, Belgium, 1200

Status
Completed
 
Locations

Nederlands Kanker Instituut

Amsterdam, Netherlands, 1066 CX

Status
Completed
 
Locations

Leids Universitair Medisch Centrum

Leiden, Netherlands, 2333 ZA

Status
Completed
 

Trial Design