?Double-blind, randomized phase II study to Evaluate the safety and efficacy of Acetyl-l-carnitine in the prevention of Sagopilone-induced peripheral Neuropathy? - REASO

• Conditions: - Advanced refractory or relapsed ovarian cancer - Metastatic hormone-refractory prostate cancer; MedDRA version: 9.1Level: LLTClassification code 10036909Term: Prostate cancer metastatic; MedDRA version: 9.1Level: LLTClassification code 10066697Term: Ovarian cancer recurrent

• Registration Number: EUCTR2008-000879-26-IT
• Lead Sponsor: BAYER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1)Histologically or cytologically proven
a)Epithelial ovarian, peritoneal cavity or Fallopian tube cancer (except mucinous or clear cell tumors) or
b)Adenocarcinoma of the prostate
Specific for HRPC:
2)At least 1 unidimensionally measurable lesion (suitable for RECIST evaluation) or for patients without measurable disease PSA value ≥ 5 ng/mL
3)Progression of disease despite adequate androgen-inhibiting hormone therapy, demonstrated by:
- rising PSA on at least 2 consecutive measurements taken at least 7 days apart. The last measurement must be  50% greater than the lowest PSA value achieved under the last previous treatment.
- PSA at least 5 ng/ml
4)PSA value at screening (4 to 6 weeks after cessation of antiandrogen treatment) must continue to be elevated
5)Serum testosterone < 50 ng/mL (ongoing treatment with luteinizing hormone-releasing hormone (LHRH) analogues or orchiectomy)
Specific for ovarian cancer
6)At least 1 unidimensionally 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.
7)Progression of disease or symptomatic relapse after previous therapy (elevated CA 125 levels alone are insufficient for inclusion).
All patients
8)Males or females aged ≥18 years
9)WHO performance status 0 to 1
10)No clinical residual neuropathy (CTCAE Grade 0 at baseline)
11)Adequate recovery from previous surgery, radiation, and chemotherapy (excluding alopecia)
12)Adequate function of major organs and systems
Hematopoietic:
-Hemoglobin:>/= 10 g/dL
-WBC:>/= 3,000/mm3
-Absolute neutrophil count:>/=1,000/mm3
-Platelet count:>/=100,000/mm3
Hepatic:
-Total bilirubin:normal
AST/ALT:Renal:
-Creatinine:Cardiovascular:
-No symptomatic congestive heart failure
-No unstable angina pectoris
-No arrhythmia needing continuous treatment
-No uncontrolled hypertension
-No MI within past 6 months
-No cerebrovascular insult within past 6 months
No other uncontrolled concurrent illness
13)Survival expectation >/= 3 months
14)Negative pregnancy test at enrollment (females of childbearing potential only)
15)Agreement to use highly effective contraception methods (intra-uterine contraceptive device IUCD, condoms, oral contraceptives, or other adequate barrier contraception) in females of child-bearing potential and adequate barrier birth control measures in men during the course of the trial and two weeks after the completion of the trial.
16)Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1)Candidacy for curative resection
2)Symptomatic brain metastases requiring whole-brain irradiation
3)Congenital bleeding diathesis, acquired coagulopathy or patients receiving full dose of anticoagulants for the treatment of thromboembolism
4)Any concomitant malignancy: the following exceptions are allowed:
a)Non-melanoma skin cancer
b)Carcinoma in situ of the cervix
c)Malignancy with definitive treatment ≥ 5 years ago without relapse
5)History of organ allograft
6)Diabetes mellitus (even if controlled only by special diet)
7)History of chronic hepatitis B or C or known HIV infection
8)Seizure disorder requiring medication (such as steroids or anti-epileptics)
9)Inability to swallow oral medication
10)Any malabsorption condition
11)Active infection
12)Breast feeding
13)Hypersensitivity to the active substance or to any of the excipients of any of the study medications
14)Any condition that in the opinion of the investigator could hamper the compliance with the study protocol.
Excluded therapies and medications, previous and concomitant:
15) Concomitant use of neurotoxic drugs
16)Concomitant use of compounds that have potentially positive effects towards symptoms of neuropathy (see section 6.1 for more details)
17)Time period between prior therapy and start of study treatment:
a)Prior radiotherapy: < 4 weeks
b)Prior flutamide or cyproterone acetate: < 4 weeks
c)Prior bicalutamide or nilutamide: < 6 weeks
18)Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry. Mitomycin C or nitrosureas should not be given within 6 weeks of study entry.
19)Major surgery less than 28 days prior to start of treatment
20)Prior treatment with epothilones
21)Use of any investigational drug within 4 weeks before start of study treatment
22)Alcohol abuse or abuse of other drugs with neurotoxic potential

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified