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

DISEASE CHARACTERISTICS:

• Patients must have histologic diagnosis of epithelial ovarian carcinoma, peritoneal primary or fallopian tube carcinoma, which is now recurrent
• Patients with the following histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner tumor, or adenocarcinoma not otherwise specified (N.O.S.)

• All patients must have had a treatment-free interval without clinical evidence of progressive disease of at least 6 months from completion of front-line chemotherapy (both platinum and taxane); front-line therapy may have included a biologic agent (i.e., bevacizumab)

  • Front-line treatment may include maintenance therapy following complete clinical or pathological response; however, maintenance cytotoxic chemotherapy must be discontinued for a minimum of 6 months prior to documentation of recurrent disease; patients receiving maintenance biological therapy or hormonal therapy are ELIGIBLE provided their recurrence is documented more than 6 months from primary cytotoxic chemotherapy completion (includes maintenance chemotherapy) AND a minimum 4 weeks has elapsed since their last infusion of biological therapy

  • Patients receiving hormonal therapy for biochemical or non-measurable recurrence disease are ELIGIBLE provided their recurrence is documented more than 6 months following the completion of primary cytotoxic chemotherapy; a minimum of 4 weeks must have expired since their last exposure to hormonal therapy

    • The complete response to front-line chemotherapy must have included a negative physical exam, normalization of CA125 if elevated at baseline, and negative radiographic assessment of disease, if obtained
    • Patients who have undergone reassessment laparotomy or laparoscopy following primary therapy are eligible for this study as long as they demonstrated a pathologic complete response based on the surgical assessment (i.e. all obtained specimens were histologically negative for disease)

• Patients with a past history of primary endometrial cancer within the last five years are excluded unless all of the following conditions are met:

  • Stage not greater than IB
  • No more than superficial myometrial invasion, without vascular or lymphatic invasion
  • No poorly differentiated subtypes, including papillary serous, clear cell, or other International Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions

• Patients must be expected to receive a minimum of 2 cycles of paclitaxel and a platinating agent for their recurrent disease; ;

  • Addition of other drugs such as bevacizumab is acceptable as long as these additional drugs are not typically associated with peripheral neuropathy
  • The initial, planned infusion duration of each dose of paclitaxel must be 3 hours or less

PATIENT CHARACTERISTICS:

• Patients must start the study with a GOG performance status of 2 or less
• Serum creatinine ≤ 2.5 mg/dL
• Neuropathy (sensory and motor) less than or equal to the National Cancer Institute (NCI) CTCAE v4.0 grade 1
• No patients with a history of seizure activity
• No patients who are unable to swallow oral medications
• Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years
• No patients of childbearing potential not practicing adequate contraception
• No patients who are pregnant or nursing
• No patients who are known to have diabetes

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Patients are excluded if their previous cancer treatment contraindicates this protocol therapy
• No patients who have received more than one previous regimen of chemotherapy (maintenance is not considered a second regimen)
• No patients receiving concurrent immunotherapy or radiotherapy
• No patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis
• No patients who are currently receiving or have received warfarin or acenocoumarol within the past 7 days
• No patients taking > 100 units of racemic vitamin E (or > 50 units of ααα-tocopherol) daily within 5 days of starting study therapy

• No patients taking other medications (Rx, OTC, or dietary supplements) to prevent or treat neuropathy within 5 days of starting study treatment; such products include:

  • Gabapentin (Neurontin ®)
  • Pregabalin (Lyrica ®)
  • Duloxetine (Cymbalta ®)
  • Alpha-lipoic acid
  • Note that tricyclic antidepressants or selective serotonin/norepinephrine-selective reuptake inhibitors prescribed for the treatment of mood disorders are allowed
• No patients with known allergies to ALC (acetyl-L-carnitine hydrochloride)