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 Ovarian, Primary Peritoneal or Fallopian Tube Cancer
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Chemotherapy-related peripheral neuropathy as measured with Functional Assessment of Cancer Therapy (FACT)/GOG-Ntx subscale
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Arm II (placebo)
Patients receive placebo PO BID on days 1-21 (during chemotherapy treatment) (maximum of 8 courses).
干预措施: Quality-of-Life Assessment (Other)
Arm I (acetyl-L-carnitine hydrochloride)
Patients receive ALC PO BID on days 1-21 (during chemotherapy treatment).
干预措施: Questionnaire Administration (Other)
Arm I (acetyl-L-carnitine hydrochloride)
Patients receive ALC PO BID on days 1-21 (during chemotherapy treatment).
干预措施: Quality-of-Life Assessment (Other)
Arm II (placebo)
Patients receive placebo PO BID on days 1-21 (during chemotherapy treatment) (maximum of 8 courses).
干预措施: Placebo (Other)
Arm II (placebo)
Patients receive placebo PO BID on days 1-21 (during chemotherapy treatment) (maximum of 8 courses).
干预措施: Questionnaire Administration (Other)
Arm I (acetyl-L-carnitine hydrochloride)
Patients receive ALC PO BID on days 1-21 (during chemotherapy treatment).
干预措施: Acetyl-L-Carnitine Hydrochloride (Dietary Supplement)
结局指标
主要结局
Chemotherapy-related peripheral neuropathy as measured with Functional Assessment of Cancer Therapy (FACT)/GOG-Ntx subscale
时间窗: Up to 3 months
次要结局
- Patient-reported sensory peripheral neuropathy, as measured by the FACT/GOG-Ntx v4 subscale(Up to 3 months)
- Quality of life, as measured by the FACT-O TOI(Up to 3 months)
- Chemotherapy-related fatigue as measured with FACT-Fatigue(Up to 3 months)