Prevention of Sagopilone-induced Neurotoxicity With Acetyl-L-Carnitine (ALC)
Information source: Bayer
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Cancer; Ovarian Cancer
Intervention: Sagopilone 16 mg/m2 i.v., Acetyl-L-Carnitine (ALC) 1000 mg tid, HRPC only: Prednisone or Prednisolone 5 mg bid (Drug); Sagopilone 16 mg/m2 i.v. and placebo 1000 mg tid, HRPC only: Prednisone or Prednisolone 5 mg bid (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
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 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.
Clinical Details
Official title: (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.
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Primary outcome: Overall incidence of peripheral neuropathy (any grade) during at most 6 cycles of Sagopilone treatment, based on the Adverse Events.
Secondary outcome: Efficacy of ALC: incidence of neuropathy of grade 3 or 4, time to onset of neuropathy, duration of neuropathy.Efficacy of ALC: Percentage of discontinuations due to neuropathy. Safety of Sagopilone in combination with ALC. Efficacy of Sagopilone: 'best overall response' according to modRECIST criteria Efficacy of Sagopilone: 'best overall response' according to CA-125 or PSA response Efficacy of Sagopilone: Time to disease progression, Progression-free survival Efficacy of Sagopilone: Duration of response Efficacy of Sagopilone: WHO performance status. Pharmacokinetic: Sagopilone concentrations (optional) Pharmacokinetic: ALC concentrations Pharmacogenomics (optional): in tumor tissue, blood and ascites
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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:
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%)
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
Locations and Contacts
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
BRUXELLES - BRUSSEL 1200, Belgium; Recruiting
Nantes 44805, France; Recruiting
SAINT HERBLAIN 44805, France; Recruiting
Caen 14076, France; Recruiting
VILLEJUIF CEDEX 94305, France; Recruiting
PARIS CEDEX 20 75960, France; Recruiting
MONTPELLIER CEDEX 34298, France; Recruiting
Bologna 40138, Italy; Recruiting
Roma 00189, Italy; Recruiting
Rimini 47900, Italy; Recruiting
AMSTERDAM 1066 CX, Netherlands; Not yet recruiting
MAASTRICHT 6229 HX, Netherlands; Recruiting
AMSTERDAM 1081 HV, Netherlands; Not yet recruiting
LEIDEN 2333 ZA, Netherlands; Not yet recruiting
Guadalajara 19002, Spain; Not yet recruiting
Salamanca 37007, Spain; Not yet recruiting
Tübingen, Baden-Württemberg 72076, Germany; Recruiting
Meldola, Forlì 47014, Italy; Recruiting
Leicester, Leicestershire LE1 5WW, United Kingdom; Recruiting
Rostock, Mecklenburg-Vorpommern 18059, Germany; Recruiting
Northwood, Middlesex HA6 2RN, United Kingdom; Recruiting
Essen, Nordrhein-Westfalen 45147, Germany; Recruiting
Magdeburg, Sachsen-Anhalt 39112, Germany; Not yet recruiting
Additional Information
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Starting date: August 2008
Ending date: April 2011
Last updated: September 29, 2009
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