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Amifostine in Treating Peripheral Neuropathy in Patients Who Have Received Chemotherapy for Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00058071
Recruitment Status : Completed
First Posted : April 9, 2003
Last Update Posted : July 9, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Gynecologic Oncology Group

Tracking Information
First Submitted Date  ICMJE April 7, 2003
First Posted Date  ICMJE April 9, 2003
Last Update Posted Date July 9, 2013
Study Start Date  ICMJE March 2003
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2006)
Improvement of neuropathy by WEST assessment at 6, 12, 18, and 24 weeks
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2006)
Improved quality of life by Functional Assessment of Cancer Therapy-GOG/NTX (FACT-GOG/NTX) at 6, 12, 18, and 24 weeks
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Amifostine in Treating Peripheral Neuropathy in Patients Who Have Received Chemotherapy for Cancer
Official Title  ICMJE A Randomized Phase III Trial of Amifostine vs. No Treatment for Platinum Induced Peripheral Neuropathy
Brief Summary

RATIONALE: Amifostine may be effective in relieving numbness, tingling, and other symptoms of peripheral neuropathy. It is not yet known whether amifostine is effective in treating peripheral neuropathy in patients who have received chemotherapy for cancer.

PURPOSE: This randomized phase III trial is studying amifostine to see how well it works compared to observation in relieving numbness, tingling, and other symptoms of peripheral neuropathy in patients who have received platinum-based chemotherapy (such as cisplatin or carboplatin) for cancer.

Detailed Description

OBJECTIVES:

  • Determine, preliminarily, whether amifostine is superior to no treatment, in terms of improving the symptoms and/or objective findings of platinum-induced peripheral neuropathy, in patients with cancer.
  • Determine the toxicity of this drug in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive amifostine IV or subcutaneously over 3 minutes on days 1, 3, and 5. Treatment continues for 12 weeks in the absence of unacceptable toxicity. Patients are observed for 12 weeks.
  • Arm II: Patients are observed for 24 weeks. After 24 weeks patients may cross over to treatment as in arm I.

Quality of life is assessed at baseline and then at 6, 12, 18, and 24 weeks after study entry.

Patients are followed at 6 and 12 weeks after study treatment, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 50-100 patients (25-50 per treatment arm) will be accrued for this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Primary Purpose: Supportive Care
Condition  ICMJE
  • Gestational Trophoblastic Tumor
  • Neurotoxicity
  • Peripheral Neuropathy
  • Unspecified Adult Solid Tumor, Protocol Specific
Intervention  ICMJE Drug: amifostine trihydrate
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 8, 2006)
100
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Prior therapy with platinum-based chemotherapy regimen for a malignancy

    • Treatment with other agents, including paclitaxel, allowed
  • Grade 2 or greater peripheral neuropathy (numbness, tingling, pain in the distal extremities) attributed to prior platinum-based chemotherapy

    • Must have persisted and be stable for 3-36 months after completion of chemotherapy
    • Duration of neuropathy no more than 3 years
  • No other possible causes for the neuropathy (e.g., alcoholism, diabetes, or peripheral vascular disease)

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • GOG 0-3

Life expectancy

  • At least 6 months

Hematopoietic

  • Not specified

Hepatic

  • Bilirubin no greater than 2.0 mg/dL

Renal

  • Creatinine no greater than 2.0 mg/dL
  • Calcium at least lower limit of normal

Cardiovascular

  • No hypotension
  • No history of cerebrovascular accident

Other

  • No other significant comorbid medical conditions that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics
  • No concurrent chemotherapy
  • No chemotherapy (including paclitaxel, cisplatin, and carboplatin) for at least 4 months after study entry

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • At least 24 hours since prior antihypertensive medications
  • No prior amifostine
  • Prior treatment on a GOG treatment protocol allowed
  • No concurrent monoamine oxidase inhibitors
  • No concurrent neurotoxic agents during and for at least 6 months after study entry
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00058071
Other Study ID Numbers  ICMJE CDR0000285700
GOG-0192
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Gynecologic Oncology Group
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Steven C. Plaxe, MD University of California, San Diego
PRS Account Gynecologic Oncology Group
Verification Date July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP