Phase 3
N=185
Glutathione in Preventing Peripheral Neuropathy Caused by Paclitaxel and Carboplatin in Patients With Ovarian Cancer, Fallopian Tube Cancer, and/or Primary Peritoneal Cancer
Chemotherapeutic Agent Toxicity · Neuropathy · Neurotoxicity Syndrome · Pain · Stage IIIA Fallopian Tube Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02311907 ↗Enrolled (actual)
185
Serious AEs
4.3%
Results posted
Feb 2017
Primary outcome: Primary: Paclitaxel/Carboplatin (PC) Induced Peripheral Neuropathy as Assessed by EORTC QLQ-CIPN20 (European Organization for Research and Treatment of Cancer (EORTC), Quality of Life (QLQ), Chemotherapy Induced Peripheral Neuropathy 20 (CIPN20)). — 83.7; 82.1 Units on a scale 1-100 — p=0.21
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Carboplatin (Drug); Glutathione (Drug); Laboratory Biomarker Analysis (Other); Paclitaxel (Drug); Placebo (Other); Quality-of-Life Assessment (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alliance for Clinical Trials in Oncology
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Paclitaxel/Carboplatin (PC) Induced Peripheral Neuropathy as Assessed by EORTC QLQ-CIPN20 (European Organization for Research and Treatment of Cancer (EORTC), Quality of Life (QLQ), Chemotherapy Induced Peripheral Neuropathy 20 (CIPN20)). |
83.7; 82.1 | 0.21 |
| SECONDARY Recurrence-free Survival (for Patients Without Clinical Evidence of Disease) |
NA; NA | 0.63 |
| SECONDARY Change in Patient Reported Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Ovarian (FACT-O) and Patient Daily-symptom Questionnaires Over Time. |
-14.3; -8.9; -4.2; 0.0; 8.3; 4.2 | — |
| SECONDARY Paclitaxel Acute Pain Syndrome Incidence and Severity Between GSH and Placebo Arms |
2.0; 2.0 | — |
| SECONDARY Percentage of Patients Delaying PC Chemotherapy Secondary to PN |
1.1; 0 | — |
| SECONDARY Percentage of Patients Undergoing Dose Reductions Secondary to PCI PN |
2.1; 1.1; 1.1; 0.0 | — |
| SECONDARY Percentage of Patients With Grade 2+ and Grade 3+ Paclitaxel/Carboplatin-induced (PCI) Peripheral Neuropathy (PN) According to the Common Terminology Criteria for Adverse Events (CTCAE) Neuropathy Scale |
38.3; 33.0; 5.3; 4.4 | — |
| SECONDARY Times to Onset of CTCAE Grade 2+ PN |
140; 234 | — |
| SECONDARY Times to Onset of CTCAE Grade 3+ PN |
NA; NA | — |
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 Criteria
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 = = 3400
- Absolute neutrophil count (ANC) >= 1500
- Platelet (PLT) >= 100,000
- Hemoglobin (HgB) > 10.0
- Creatinine = 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
Data sourced from ClinicalTrials.gov (NCT02311907). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.