Clinical Trial: Acetyl-L-Carnitine Hydrochloride in Preventing Peripheral Neuropathy in Patients With Recurrent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer Undergoing Chemotherapy

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: A Randomized, Double-Blinded, Placebo Controlled Phase III Trial Using Acetyl-L-Carnitine(ALC)(NSC# 747431) for the Prevention of Chemotherapy-Induced Peripheral Neuropathy in Patients With Recurrent

Brief Summary: This randomized phase III trial studies how well acetyl-L-carnitine hydrochloride works compared to a placebo in preventing peripheral neuropathy in patients with recurrent ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer undergoing chemotherapy. Acetyl-L-carnitine hydrochloride may prevent or lessen peripheral neuropathy caused by chemotherapy. It is not yet known whether acetyl-L-carnitine hydrochloride is more effective compared to a placebo in preventing peripheral neuropathy caused by chemotherapy.

Detailed Summary:

PRIMARY OBJECTIVES:

I. Evaluate the therapeutic efficacy of acetyl-L-carnitine hydrochloride (ALC) in preventing chemotherapy-induced peripheral neuropathy (CIPN) in patients with recurrent ovarian, primary peritoneal, or fallopian tube cancer.

SECONDARY OBJECTIVES:

I. Evaluate the effect of ALC on chemotherapy-induced fatigue based upon the Functional Assessment of Cancer Therapy (FACT)-Fatigue scale.

II. Evaluate the effect of ALC on sensory peripheral neuropathy as measured with the first 4 items of the FACT/Gynecologic Oncology Group (GOG)-Neurotoxicity (Ntx) subscale (FACT/GOG-Ntx_4 subscale).

III. Evaluate the effect of ALC on the health-related quality of life as measured by the FACT-Ovarian (O) trial outcome index (TOI).

OUTLINE: This is a multicenter study. Patients are stratified according to planned dosage of paclitaxel (< 150 mg/m^2 vs ≥ 150 mg/m^2), and age (< 60 years of age vs ≥ 6 years of age). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive acetyl-L-carnitine hydrochloride (ALC) orally (PO) twice daily (BID) on days 1-21 (during chemotherapy treatment).

ARM II: Patients receive placebo PO BID on days 1-21 (during chemotherapy treatment) (maximum of 8 courses).

In both arms, treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

Patients also complete questionnaires comprising the Functional Assessment of Cancer
Sponsor: Gynecologic Oncology Group

Current Primary Outcome: Chemotherapy-related peripheral neuropathy as measured with Functional Assessment of Cancer Therapy (FACT)/GOG-Ntx subscale [ Time Frame: Up to 3 months ]

Original Primary Outcome: Effect of ALC compared to placebo in preventing the chemotherapy-related peripheral neuropathy as measured with FACT/GOG-Ntx subscale

Current Secondary Outcome:

  • Chemotherapy-related fatigue as measured with FACT-Fatigue [ Time Frame: Up to 3 months ]
  • Patient-reported sensory peripheral neuropathy, as measured by the FACT/GOG-Ntx v4 subscale [ Time Frame: Up to 3 months ]
  • Quality of life, as measured by the FACT-O TOI [ Time Frame: Up to 3 months ]
    Tested at significance level of 5%.


Original Secondary Outcome:

  • Effect of ALC compared to placebo in preventing the chemotherapy-related fatigue as measured with FACT-Fatigue
  • Effect of ALC vs placebo on preventing the patient-reported sensory peripheral neuropathy, as measured by the FACT/GOG-Ntx_4 subscale
  • Effect of ALC on the quality of life, as measured by the FACT-O TOI


Information By: Gynecologic Oncology Group

Dates:
Date Received: December 14, 2011
Date Started: April 2012
Date Completion:
Last Updated: December 29, 2014
Last Verified: December 2014