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


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Chemotherapeutic Agent Toxicity, Fallopian Tube Cancer, Neurotoxicity, Ovarian Cancer, Pain, Peripheral Neuropathy, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

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


OBJECTIVES:

Primary

- To compare paclitaxel/carboplatin (PC)-induced (PCI) peripheral neuropathy (PN) as
measured by EORTC-QLQ-CIPN20 between patients with ovarian cancer and/or primary
peritoneal carcinoma treated with glutathione vs placebo.

Secondary

- To compare the incidences of grade 2+ and grade 3+ PCI PN as measured by CTCAE
neuropathy scale between the glutathione and placebo arms.

- To compare the time to onset of grade 2+ and grade 3+ PCI PN between the treatment arms
as measured by CTCAE neuropathy scale.

- To compare the proportion of patients requiring chemotherapy dose reductions secondary
to PCI PN between the treatment arms.

- To compare the proportion of patients stopping PC secondary to peripheral neuropathy
between the arms.

- To assess the toxicity profile of glutathione in this situation.

- To evaluate whether glutathione influences the antitumor activity of PC.

- To evaluate patient quality of life as measured by FACT-O and patient daily-symptom
questionnaires over time between the treatment arms.

Tertiary (exploratory)

- To explore the association of genetic variations in genes involved in taxane/platinum
metabolism with the incidence of grade 2+ PCI PN.

- To bank blood products for future studies.

OUTLINE: Patients are stratified according to baseline neuropathy (none vs grade 1), age (≤
50 years vs > 50 years), debulked status (no gross residual disease [no clinically apparent
residual lesions at the completion of primary surgery] vs optimal [largest residual lesion <
1 cm at primary surgery] vs sub-optimally debulked [residual lesion > 1 cm] or not operated
upon), concurrent use of bevacizumab (yes vs no), paclitaxel planned dose (weekly vs every 3
weeks), and diabetes requiring insulin or oral hypoglycemic medications (yes vs no).
Patients are randomized to 1 of 2 treatment arms.

Ideally, patients begin receiving glutathione before their first dose of chemotherapy, but
must begin glutathione before their second dose of chemotherapy.

- Arm I: Patients receive glutathione IV over 15 minutes, paclitaxel* IV over 3 hours,
and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at
least 12 weeks in the absence of disease progression or unacceptable toxicity.

- Arm II: Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and
carboplatin IV over 30 minutes as in arm I.

NOTE: * Alternatively, patients may receive paclitaxel IV over 1 hour and
glutathione/placebo IV over 15 minutes weekly and carboplatin every 21 days for 12 weeks.

Blood samples are collected periodically for pharmacogenomic and other biomarker analyses.
Patients complete questionnaires periodically, including quality-of-life assessments.

After completion of study treatment, patients are followed up every 3 months for 1 year.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of stage III/IV ovarian cancer, fallopian tube cancer, and/or primary
peritoneal carcinoma

- Scheduled to undergo treatment with paclitaxel at 175 mg/m^2 and carboplatin at area
under the curve = 6 every 21 days for 6 courses with or without bevacizumab

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Life expectancy ≥ 6 months

- WBC ≥ 3,400/mm^3

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin > 10.0 g/dL

- Creatinine ≤ 1.5 times upper limit of normal

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Able to complete English language questionnaire(s) alone or with assistance

- Willing to provide blood specimens as required by the study

- No pre-existing history of peripheral neuropathy > grade 1 (NCI CTCAE v4.0) due to
any cause (e.g., chemotherapy, diabetes, alcohol, toxin, or heredity)

- No other medical conditions that, in the opinion of the treating physician/allied
health professional, would make this study unreasonably hazardous for the patient

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior paclitaxel or carboplatin other than the current treatment regimen

- No other concurrent treatment for the prevention of peripheral neuropathy, including
prescription and over-the-counter or herbal therapies

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Outcome Measure:

Paclitaxel/carboplatin (PC)-induced (PCI) peripheral neuropathy (PN) as assessed by EORTC QLQ-CIPN20

Safety Issue:

No

Principal Investigator

Charles L. Loprinzi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

North Central Cancer Treatment Group

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000654097

NCT ID:

NCT00979082

Start Date:

December 2009

Completion Date:

Related Keywords:

  • Chemotherapeutic Agent Toxicity
  • Fallopian Tube Cancer
  • Neurotoxicity
  • Ovarian Cancer
  • Pain
  • Peripheral Neuropathy
  • Primary Peritoneal Cavity Cancer
  • neurotoxicity
  • chemotherapeutic agent toxicity
  • pain
  • peripheral neuropathy
  • stage IIIA ovarian epithelial cancer
  • stage IIIB ovarian epithelial cancer
  • stage IIIC ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • stage IIIA primary peritoneal cavity cancer
  • stage IIIB primary peritoneal cavity cancer
  • stage IIIC primary peritoneal cavity cancer
  • stage IV primary peritoneal cavity cancer
  • stage IIIA fallopian tube cancer
  • stage IIIB fallopian tube cancer
  • stage IIIC fallopian tube cancer
  • stage IV fallopian tube cancer
  • Ovarian Neoplasms
  • Peripheral Nervous System Diseases
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neurotoxicity Syndromes
  • Demyelinating Diseases
  • Polyneuropathies
  • Nerve Compression Syndromes
  • Neurologic Manifestations

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