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

NCT01492920 | Withdrawn Phase 3

• 4 other identifiers: GOG-0257NCI-2012-00090CDR0000719317U10CA101165
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fatigue; Malignant Ovarian Mixed Epithelial Tumor; Neuropathy; Neurotoxicity Syndrome; Ovarian Brenner Tumor; Ovarian Clear Cell Cystadenocarcinoma; Ovarian Endometrioid Adenocarcinoma; Ovarian Mucinous Cystadenocarcinoma; Ovarian Serous Cystadenocarcinoma; Pain; Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Chemotherapy-related peripheral neuropathy as measured with Functional Assessment of Cancer Therapy (FACT)/GOG-Ntx subscale

  Up to 3 months

Secondary Outcomes (3)

• Chemotherapy-related fatigue as measured with FACT-Fatigue

  Up to 3 months

• 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

Study Arms (2)

Arm I (acetyl-L-carnitine hydrochloride)

EXPERIMENTAL

Patients receive ALC PO BID on days 1-21 (during chemotherapy treatment).

Dietary Supplement: Acetyl-L-Carnitine Hydrochloride; Other: Questionnaire Administration; Other: Quality-of-Life Assessment

Arm II (placebo)

PLACEBO COMPARATOR

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

Other: Placebo; Other: Questionnaire Administration; Other: Quality-of-Life Assessment

Interventions

Acetyl-L-Carnitine Hydrochloride DIETARY_SUPPLEMENT

Given orally

Also known as: Acetylcarnitine Hydrochloride, L-, Acetylcarnitine L-form HCl

Arm I (acetyl-L-carnitine hydrochloride)

Placebo OTHER

Given orally

Also known as: PLCB

Arm II (placebo)

Questionnaire Administration OTHER

Ancillary studies

Arm I (acetyl-L-carnitine hydrochloride); Arm II (placebo)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (acetyl-L-carnitine hydrochloride); Arm II (placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Gynecologic Oncology Group: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Fatigue; Neurotoxicity Syndromes; Brenner Tumor; Pain; Fallopian Tube Neoplasms; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Poisoning; Chemically-Induced Disorders; Neoplasms, Fibroepithelial; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Neurologic Manifestations; Neoplasms by Site; Fallopian Tube Diseases; Endocrine Gland Neoplasms

Study Officials

• David Kushner

  Gynecologic Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2011
• First Posted: December 15, 2011
• Study Start: April 1, 2012
• Primary Completion: May 1, 2015
• Last Updated: December 31, 2014

Record last verified: 2014-12