Status:
COMPLETED
Prevention of Sagopilone-induced Neurotoxicity With Acetyl-L-Carnitine (ALC)
Lead Sponsor:
Bayer
Conditions:
Prostate Cancer
Ovarian Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 neuro...
Eligibility Criteria
Inclusion
- 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:
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00751205
Start Date
August 1 2008
End Date
August 1 2010
Last Update
October 28 2014
Active Locations (22)
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1
Bruxelles - Brussel, Belgium, 1200
2
Caen, France, 14076
3
Montpellier, France, 34298
4
Nantes, France, 44805