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A Randomized Phase III Trial of Amifostine vs. No Treatment for Platinum Induced Peripheral Neuropathy


Phase 3
18 Years
N/A
Not Enrolling
Both
Gestational Trophoblastic Tumor, Neurotoxicity, Peripheral Neuropathy, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Randomized Phase III Trial of Amifostine vs. No Treatment for Platinum Induced Peripheral Neuropathy


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Outcome Measure:

Improvement of neuropathy by WEST assessment at 6, 12, 18, and 24 weeks

Principal Investigator

Steven C. Plaxe, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Diego

Authority:

United States: Federal Government

Study ID:

CDR0000285700

NCT ID:

NCT00058071

Start Date:

March 2003

Completion Date:

Related Keywords:

  • Gestational Trophoblastic Tumor
  • Neurotoxicity
  • Peripheral Neuropathy
  • Unspecified Adult Solid Tumor, Protocol Specific
  • peripheral neuropathy
  • neurotoxicity
  • hydatidiform mole
  • unspecified adult solid tumor, protocol specific
  • Peripheral Nervous System Diseases
  • Trophoblastic Neoplasms
  • Neurotoxicity Syndromes
  • Demyelinating Diseases
  • Polyneuropathies
  • Nerve Compression Syndromes
  • Neurologic Manifestations
  • Gestational Trophoblastic Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
CCOP - Carle Cancer CenterUrbana, Illinois  61801
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain CampusNew Britain, Connecticut  06050
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Hinsdale Hematology Oncology AssociatesHinsdale, Illinois  60521
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Avera Cancer InstituteSioux Falls, South Dakota  57105
Providence Saint Joseph Medical Center - BurbankBurbank, California  91505
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State UniversityColumbus, Ohio  43210-1240
Sunrise Hospital and Medical CenterLas Vegas, Nevada  89109-2306
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
SUNY Downstate Medical CenterBrooklyn, New York  11203
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Cancer Care Associates - Midtown TulsaTulsa, Oklahoma  74104
Sioux Valley Hospital and University of South Dakota Medical CenterSioux Falls, South Dakota  57117-5134
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
Aultman Hospital Cancer Center at Aultman Health FoundationCanton, Ohio  44710-1799
William Beaumont Hospital - Royal Oak CampusRoyal Oak, Michigan  48073
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781
University of Illinois Cancer CenterChicago, Illinois  60612-7243
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Elkhart General HospitalElkhart, Indiana  46515
Lakeland Regional Cancer Care Center - St. JosephSt. Joseph, Michigan  49085
Women's Cancer Center - Lake MeadLas Vegas, Nevada  89102
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarlton, New Jersey  08053
Fox Chase Virtua Health Cancer Program at Virtua West JerseyVoorhees, New Jersey  08043
Mount Carmel Health - West HospitalColumbus, Ohio  43222
Hillcrest Cancer Center at Hillcrest HospitalMayfield Heights, Ohio  44124
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
Lakeland Regional Cancer Center at Lakeland Regional Medical CenterLakeland, Florida  33805
Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Ella Milbank Foshay Cancer Center at Jupiter Medical CenterJupiter, Florida  33458
Ingalls Cancer Care Center at Ingalls Memorial HospitalHarvey, Illinois  60426
Howard Community Hospital at Howard Regional Health SystemKokomo, Indiana  46904
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
University of Miami Sylvester Comprehensive Cancer Center - MiamiMiami, Florida  33136
FirstHealth Moore Regional Community Hospital Comprehensive Cancer CenterPinehurst, North Carolina  28374
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
St. Vincent's Medical CenterJacksonville, Florida  32203
Louisville Oncology at Norton Cancer CenterLouisville, Kentucky  40202