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NCT Number: NCT00751205

Prevention of Sagopilone-induced Neurotoxicity With Acetyl-L-Carnitine (ALC)

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.

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Key information

Conditions

Prostate Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Male Urogenital Diseases Neoplasms Neoplasms by Site Nervous System Diseases Neuromuscular Diseases Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Peripheral Nervous System Diseases Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Bruxelles - Brussel, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

Treatment and study plan

Sagopilone 16 mg/m^2 i.v., Acetyl-L-Carnitine (ALC) 1000 mg tid, HRPC only: Prednisone or Prednisolone 5 mg bid

Drug

Subjects will receive intravenous (i.v.) infusion of Sagopilone for 3 hours on day 1 of a 3-weeks cycle. In addition, subjects will receive Acetyl-L-Carnitine (ALC) 1000 mg tid. Treatment with Sagopilone and ALC will be continued as long as there is benefit. Subjects with HRPC will also receive Prednisone or Prednisolone 5 mg bid, throughout the treatment with Sagopilone.

Sagopilone 16 mg/m^2 i.v. and placebo 1000 mg tid, HRPC only: Prednisone or Prednisolone 5 mg bid

Drug

Subjects will receive intravenous (i.v.) infusion of Sagopilone for 3 hours on day 1 of a 3-weeks cycle. Treatment will be continued as long as there is benefit. In addition, subjects will receive 21 weeks of placebo 1000 mg tid. After all patients have completed 6 cycles of treatment, an analysis will be performed to see whether ALC was better than placebo. If this is the case, patients still under placebo treatment will be offered to switch to ALC. Subjects with HRPC will also receive Prednisone or Prednisolone 5 mg bid, throughout the treatment with Sagopilone.

Primary outcomes

  1. Overall incidence of peripheral neuropathy (any grade) during at most 6 cycles of Sagopilone treatment, based on the Adverse Events.

    Time frame: Start of Sagopilone treatment until at most 6 cycles + 1 month.

Secondary outcomes

  1. Efficacy of ALC: incidence of neuropathy of grade 3 or 4, time to onset of neuropathy, duration of neuropathy.

    Time frame: Start of treatment to safety Follow-up

  2. Efficacy of ALC: Percentage of discontinuations due to neuropathy.

    Time frame: Start of treatment to safety Follow-up

  3. Safety of Sagopilone in combination with ALC.

    Time frame: Baseline to Safety follow-up

  4. Efficacy of Sagopilone: 'best overall response' according to modRECIST criteria

    Time frame: Start treatment to End of Treatment

  5. Efficacy of Sagopilone: 'best overall response' according to CA-125 or PSA response

    Time frame: Start treatment to End of Treatment

  6. Efficacy of Sagopilone: Time to disease progression, Progression-free survival

    Time frame: Start treatment to Progression or Death

  7. Efficacy of Sagopilone: Duration of response

    Time frame: Start treatment to Progression or Death

  8. Efficacy of Sagopilone: WHO performance status.

    Time frame: Screening to end of Treatment

  9. Pharmacokinetic: Sagopilone concentrations (optional)

    Time frame: Day 1,2,3,5,15 of cycle 1 and day2

  10. Pharmacokinetic: ALC concentrations

    Time frame: radomisation, day 1 of cycle 1 and 2

  11. Pharmacogenomics (optional): in tumor tissue, blood and ascites

    Time frame: Blood sample at screening, tissue sample and ascites whenever available

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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.

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 11, 2008
Registry last updated
Oct 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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