(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.
- 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
- Adequate function of major organs and systems.
- Survival expectation =3 months
- Histologically or cytologically proven:
1. 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