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FatiguePhase 3NCT01492920

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

A Phase 3 study testing Acetyl-L-Carnitine Hydrochloride, Questionnaire Administration and Quality-of-Life Assessment in people with Fatigue and Malignant Ovarian Mixed Epithelial Tumor, run by Gynecologic Oncology Group.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Acetyl-L-Carnitine Hydrochloride, Questionnaire Administration and Quality-of-Life Assessment
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
Apr 2012to May 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 36Show fewer
  • 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

Who cannot join

None listed.

About this study

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 Ovarian, Primary Peritoneal or Fallopian Tube Cancer

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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 Therapy (FACT)-Fatigue scale, the FACT-Gynecologic Oncology Group Neurotoxicity subscale (FACT/GOG-Ntx_4 subscale), and the FACT-Ovarian trial outcome index (FACT-O TOI) at baseline, prior to courses 3 and 5, within 4 weeks after completion of treatment, and then at 3 months after completion of treatment.

Being tested
Acetyl-L-Carnitine Hydrochloride, Placebo, Questionnaire Administration, Quality-of-Life Assessment
Medical subject headings
Fatigue, Neurotoxicity Syndromes, Brenner Tumor, Pain, Fallopian Tube Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acetyl-L-Carnitine HydrochlorideDietary supplement

    Also called Acetylcarnitine Hydrochloride, L-, Acetylcarnitine L-form HCl

    Given orally

  • PlaceboOther

    Also called PLCB

    Given orally

  • Questionnaire AdministrationOther

    Ancillary studies

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

Study groups in NCT01492920
Study groupRoleWhat they receive
Arm I (acetyl-L-carnitine hydrochloride)ExperimentalPatients receive ALC PO BID on days 1-21 (during chemotherapy treatment).
Receives: Dietary Supplement: Acetyl-L-Carnitine Hydrochloride; Other: Questionnaire Administration; Other: Quality-of-Life Assessment
Arm II (placebo)Placebo comparatorPatients receive placebo PO BID on days 1-21 (during chemotherapy treatment) (maximum of 8 courses).
Receives: Other: Placebo; Other: Questionnaire Administration; Other: Quality-of-Life Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to 3 months

Secondary outcomes (3)

  1. Chemotherapy-related fatigue as measured with FACT-Fatigue

    Measured: Up to 3 months

  2. Patient-reported sensory peripheral neuropathy, as measured by the FACT/GOG-Ntx v4 subscale

    Measured: Up to 3 months

  3. Quality of life, as measured by the FACT-O TOI

    Tested at significance level of 5%.

    Measured: Up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2011 (estimated)
  2. Study startApr 2012
  3. Primary completionMay 2015 (estimated)

Why it stopped: Withdrawn

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01492920
Sponsor's protocol ID
GOG-0257
Other IDs
NCI-2012-00090, CDR0000719317, GOG-0257, GOG-0257, GOG-0257, U10CA101165
Status last verified
Dec 2014
First submitted
14 Dec 2011
Last updated
31 Dec 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Acetyl-L-Carnitine Hydrochloride, Questionnaire Administration and Quality-of-Life Assessment in people with Fatigue and Malignant Ovarian Mixed Epithelial Tumor, run by Gynecologic Oncology Group.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 36 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 31 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Chemotherapy-related peripheral neuropathy as measured with Functional Assessment of Cancer Therapy (FACT)/GOG-Ntx subscale (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01492920.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2014.

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