Loyola University Medical Center

Gottlieb Memorial Hospital

MacNeal Hospital

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NCT02311907

Glutathione in Preventing Peripheral Neuropathy Caused by Paclitaxel and Carboplatin in Patients With Ovarian Cancer, Fallopian Tube Cancer, and/or Primary Peritoneal Cancer

Official Title:

The Use of Glutathione (GSH) for Prevention of Paclitaxel/Carboplatin (TAXOL/CBDCA) Induced Peripheral Neuropathy: A Phase III Randomized, Double-Blind Placebo Controlled Study

Summary

This randomized phase III trial is studying glutathione to see how well it works in preventing peripheral neuropathy caused by paclitaxel and carboplatin in patients with ovarian cancer, fallopian tube cancer, and/or primary peritoneal cancer. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as glutathione, may help prevent peripheral neuropathy caused by paclitaxel and carboplatin. It is not yet known whether glutathione is more effective than a placebo in preventing peripheral neuropathy.

Eligibility

Inclusion Criteria:

* Scheduled to undergo treatment with TAXOL at 150-200 mg/m2 and CBDCA at area under the curve (AUC) = 5-7 every 21 or 28 days for at least 12 weeks; alternatively, paclitaxel can be prescribed at 80 mg/m2 weekly for at least 12 weeks, with the same CBDCA dose of AUC = 5-7 every 21 days; additional chemotherapy agents are allowed (bevacizumab, etoposide, etc) per physician discretion, as long as they are not known to be neurotoxic; Note: patients ideally will begin GSH therapy prior to their first dose of this chemotherapy, but must begin GSH therapy prior to their second dose of chemotherapy
* Ability to sign informed consent and understand the nature of a placebo-controlled trial
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Ability to complete English language questionnaire(s) by themselves or with assistance
* Life expectancy >= 6 months
* Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only, per clinician discretion
* Willingness to provide blood specimens as required by the protocol
* White blood cell (WBC) >= 3400
* Absolute neutrophil count (ANC) >= 1500
* Platelet (PLT) >= 100,000
* Hemoglobin (HgB) > 10.0
* Creatinine =< 1.5 x upper limit of normal (ULN)

Exclusion Criteria:

* Pre-existing history of peripheral neuropathy > grade 1 (National Cancer Institute \[NCI\] CTCAE version \[v\] 4.0) due to any cause (e.g., chemotherapy, diabetes, alcohol, toxin, or heredity)
* Other medical conditions, which in the opinion of the treating physician/allied health professional would make this protocol unreasonably hazardous for the patient
* Any of the following:

* Pregnant women
* Nursing women
* Women of childbearing potential who are unwilling to employ adequate contraception
* Prior TAXOL and/or CBDCA chemotherapy treatment (other than the current treatment regimen)
* Concurrent use of any agent being used specifically to prevent or treat neuropathy, including but not limited to the following:

* Gabapentin
* Glutamine powder or glutamine tablets
* Vitamin B6 or E

Disease(s) and\or Condition(s)

Chemotherapeutic Agent Toxicity

Neuropathy

Neurotoxicity Syndrome

Pain

Stage IIIA Fallopian Tube Cancer

Stage IIIA Ovarian Cancer

Stage IIIA Primary Peritoneal Cancer

Stage IIIB Fallopian Tube Cancer

Stage IIIB Ovarian Cancer

Stage IIIB Primary Peritoneal Cancer

Stage IIIC Fallopian Tube Cancer

Stage IIIC Ovarian Cancer

Stage IIIC Primary Peritoneal Cancer

Stage IV Fallopian Tube Cancer

Stage IV Ovarian Cancer

Stage IV Primary Peritoneal Cancer

Primary Purpose
  • SUPPORTIVE_CARE
Intervention/Treatment
    • Type: DRUG
    • Name: Carboplatin
    • Description: Given IV, over 30 minutes per planned chemotherapy regimen
    • Arm Group Labels: Arm I (glutathione, carboplatin), Arm II (placebo, paclitaxel)
    • Type: DRUG
    • Name: Glutathione
    • Description: Given IV, over 15 minutes, immediately before chemotherapy administration
    • Arm Group Labels: Arm I (glutathione, carboplatin)
    • Type: OTHER
    • Name: Laboratory Biomarker Analysis
    • Description: Correlative studies
    • Arm Group Labels: Arm I (glutathione, carboplatin), Arm II (placebo, paclitaxel)
    • Type: DRUG
    • Name: Paclitaxel
    • Description: Given IV, over 1 or 3 hours, per planned chemotherapy regimen
    • Arm Group Labels: Arm I (glutathione, carboplatin), Arm II (placebo, paclitaxel)
    • Type: OTHER
    • Name: Placebo
    • Description: Given IV
    • Arm Group Labels: Arm II (placebo, paclitaxel)
    • Type: OTHER
    • Name: Quality-of-Life Assessment
    • Description: Ancillary studies
    • Arm Group Labels: Arm I (glutathione, carboplatin), Arm II (placebo, paclitaxel)
Sponsor
  • Alliance for Clinical Trials in Oncology