Trial Condition(s):
Prevention of Sagopilone-induced neurotoxicity with Acetyl-L-Carnitine (ALC)
91695
Not Available
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.
- 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%)
- 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
Locations | |
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Locations Klinikum der Eberhard-Karls-Universität Tübingen Tübingen, Germany, 72076 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Essen Essen, Germany, 45122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Südstadt Rostock, Germany, 18059 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre René Gauducheau Nantes, France, 44805 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre René Gauducheau - Nantes NANTES, France, 44805 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Diaconesses Croix Saint Simon - Paris Paris, France, 75012 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Val d'Aurelle - Montpellier MONTPELLIER CEDEX, France, 34298 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRST Istituto Scientifico Romagnolo per studio e cura Tumori Meldola, Italy, 47014 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AUSL Rimini - Emilia Romagna Rimini, Italy, 47900 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Academisch Ziekenhuis Maastricht Maastricht, Netherlands, 6229 HX | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Vrije Universiteit Medisch Centrum AMSTERDAM, Netherlands, 1081 HV | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Essen Essen, Germany, 45147 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Otto-von-Guericke-Universität Magdeburg Magdeburg, Germany, 38108 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medizinische Einrichtungen der Universität Bonn Bonn, Germany, 53105 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mount Vernon Hospital Northwood, United Kingdom, HA6 2RN | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Leicester Royal Infirmary Leicester, United Kingdom, LE1 5WW | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Francois Baclesse Caen, France, 14076 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Institut Gustave Roussy - Villejuif VILLEJUIF, France, 94805 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. di Bologna Bologna, Italy, 40138 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Sant'Andrea Roma, Italy, 00189 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CU Saint-Luc/UZ St-Luc BRUXELLES - BRUSSEL, Belgium, 1200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nederlands Kanker Instituut Amsterdam, Netherlands, 1066 CX | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Leids Universitair Medisch Centrum Leiden, Netherlands, 2333 ZA | Contact Us: E-mail: [email protected] Phone: Not Available |
(REASON) Double-blind, Randomized phase II study to Evaluate the safety and efficacy of Acetyl-l-carnitine in the prevention of Sagopilone-induced peripheral Neuropathy.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2