Status:
WITHDRAWN
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
Lead Sponsor:
Gynecologic Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Fatigue
Malignant Ovarian Mixed Epithelial Tumor
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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, ...
Detailed Description
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, ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
- 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
- No patients with known allergies to ALC (acetyl-L-carnitine hydrochloride)
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01492920
Start Date
April 1 2012
Last Update
December 31 2014
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