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

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ClinicalTrials.gov Identifier: NCT02311907
Recruitment Status : Completed
First Posted : December 9, 2014
Results First Posted : February 23, 2017
Last Update Posted : February 23, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Supportive Care
Conditions: 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
Interventions: Drug: Carboplatin
Drug: Glutathione
Other: Laboratory Biomarker Analysis
Drug: Paclitaxel
Other: Placebo
Other: Quality-of-Life Assessment

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Total of 195 patients were enrolled, 185 started the treatment (8 cancels, 1 ineligible and 1 excluded due to switching regimens).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
A (Glutathione, Carboplatin) 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.
B (Placebo, Paclitaxel) Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.

Participant Flow:   Overall Study
    A (Glutathione, Carboplatin)   B (Placebo, Paclitaxel)
STARTED   94   91 
COMPLETED   94   91 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
A (Glutathione, Carboplatin) 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.
B (Placebo, Paclitaxel) Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
Total Total of all reporting groups

Baseline Measures
   A (Glutathione, Carboplatin)   B (Placebo, Paclitaxel)   Total 
Overall Participants Analyzed 
[Units: Participants]
 94   91   185 
Age 
[Units: Years]
Median (Full Range)
 63 
 (37 to 85) 
 63 
 (28 to 84) 
 63 
 (28 to 85) 
Gender 
[Units: Participants]
Count of Participants
     
Female      74  78.7%      76  83.5%      150  81.1% 
Male      20  21.3%      15  16.5%      35  18.9% 
Region of Enrollment 
[Units: Participants]
     
United States   94   91   185 


  Outcome Measures

1.  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)).   [ Time Frame: Every 28 day cycle, up to 6 cycles. ]

2.  Secondary:   Recurrence-free Survival (for Patients Without Clinical Evidence of Disease)   [ Time Frame: Up to 1 year ]

3.  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.   [ Time Frame: Baseline to 1 year ]

4.  Secondary:   Paclitaxel Acute Pain Syndrome Incidence and Severity Between GSH and Placebo Arms   [ Time Frame: Up to 1 year ]

5.  Secondary:   Percentage of Patients Delaying PC Chemotherapy Secondary to PN   [ Time Frame: Up to 1 year ]

6.  Secondary:   Percentage of Patients Undergoing Dose Reductions Secondary to PCI PN   [ Time Frame: Up to 1 year ]

7.  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   [ Time Frame: Up to 1 year ]

8.  Secondary:   Times to Onset of CTCAE Grade 2+ PN   [ Time Frame: Up to 1 year ]

9.  Secondary:   Times to Onset of CTCAE Grade 3+ PN   [ Time Frame: Up to 5 years from registration ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Charles L. Loprinzi M.D.
Organization: Mayo Clinic
phone: 507/284-1623
e-mail: cloprinzi@mayo.edu



Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT02311907     History of Changes
Obsolete Identifiers: NCT00979082
Other Study ID Numbers: N08CA
NCI-2011-01965 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000654097
U10CA037404 ( U.S. NIH Grant/Contract )
First Submitted: December 8, 2014
First Posted: December 9, 2014
Results First Submitted: July 19, 2016
Results First Posted: February 23, 2017
Last Update Posted: February 23, 2017