Gestational Trophoblastic TumorPhase 3NCT00058071
Amifostine in Treating Peripheral Neuropathy in Patients Who Have Received Chemotherapy for Cancer
A Phase 3 study testing amifostine trihydrate in people with Gestational Trophoblastic Tumor and Neurotoxicity, run by Gynecologic Oncology Group at 57 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gestational Trophoblastic Tumor, Neurotoxicity, Peripheral Neuropathy
- What is being tested?
- amifostine trihydrate
- How many people
- 100 participants
- Where
- 57 sitesUnited States
- Study dates
- Mar 2003to Dec 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
57 sites in 1 country.
57 sites in 1 country
United States57 sites
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, 19001
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, 44307
Rush-Copley Cancer Care Center
Aurora, Illinois, 60507
SUNY Downstate Medical Center
Brooklyn, New York, 11203
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
Providence Saint Joseph Medical Center - Burbank
Burbank, California, 91505
Aultman Hospital Cancer Center at Aultman Health Foundation
Canton, Ohio, 44710-1799
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599-7295
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, 28232-2861
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611-3013
University of Illinois Cancer Center
Chicago, Illinois, 60612-7243
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, 45267
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, 43210-1240
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, 43214-3998
Mount Carmel Health - West Hospital
Columbus, Ohio, 43222
Elkhart General Hospital
Elkhart, Indiana, 46515
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, 60426
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, 60521
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, 52242
University of Mississippi Cancer Clinic
Jackson, Mississippi, 39216
St. Vincent's Medical Center
Jacksonville, Florida, 32204
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, 60435
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter, Florida, 33458
Howard Community Hospital at Howard Regional Health System
Kokomo, Indiana, 46904
Moores UCSD Cancer Center
La Jolla, California, 92093-0658
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, 46350
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
Lakeland, Florida, 33805
Women's Cancer Center - Lake Mead
Las Vegas, Nevada, 89102
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, 90095-1781
Louisville Oncology at Norton Cancer Center
Louisville, Kentucky, 40202
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, 08053
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, 44124
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, 33136
Saint Anthony Memorial Health Centers
Michigan City, Indiana, 46360
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
New Britain, Connecticut, 06050
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, 73104
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, 19111-2497
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
Pinehurst, North Carolina, 28374
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, 48073
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, 49085
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, 31403-3089
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, 57117-5039
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
Memorial Hospital of South Bend
South Bend, Indiana, 46601
Saint Joseph Regional Medical Center
South Bend, Indiana, 46617
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, 62781-0001
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65802
St. John's Regional Health Center
Springfield, Missouri, 65804
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, 65807
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, 63110
Cancer Care Associates - Midtown Tulsa
Tulsa, Oklahoma, 74104
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, 61801
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, 08043
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees Township, New Jersey, 08043
About this study
Official title: A Randomized Phase III Trial of Amifostine vs. No Treatment for Platinum Induced Peripheral Neuropathy
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.
Read the 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.
- Conditions
- Gestational Trophoblastic Tumor, Neurotoxicity, Peripheral Neuropathy, Unspecified Adult Solid Tumor, Protocol Specific
- Being tested
- amifostine trihydrate
- Keywords
- peripheral neuropathy, neurotoxicity, hydatidiform mole, unspecified adult solid tumor, protocol specific
- Medical subject headings
- Gestational Trophoblastic Disease, Neurotoxicity Syndromes, Peripheral Nervous System Diseases, Hydatidiform Mole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amifostine trihydrateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of neuropathy by WEST assessment at 6, 12, 18, and 24 weeks
Secondary outcomes (1)
Improved quality of life by Functional Assessment of Cancer Therapy-GOG/NTX (FACT-GOG/NTX) at 6, 12, 18, and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2003 (estimated)
- Study startMar 2003
- Primary completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Trophoblastic TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Steven C. Plaxe, MD, Study chair, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00058071
- Sponsor's protocol ID
- CDR0000285700
- Other IDs
- GOG-0192
- Status last verified
- Jul 2007
- First submitted
- 7 Apr 2003
- Last updated
- 9 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Trial of Amifostine vs. No Treatment for Platinum Induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT00058071
- Acronym / sponsor ID
- CDR0000285700
- Conditions
- Gestational Trophoblastic Tumor, Neurotoxicity, Peripheral Neuropathy, Unspecified Adult Solid Tumor, Protocol Specific
- Keywords
- peripheral neuropathy, neurotoxicity, hydatidiform mole, unspecified adult solid tumor, protocol specific
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Gynecologic Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2003
- Primary completion
- Dec 2007 (actual)
- First posted
- 9 Apr 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| amifostine trihydrate | Drug | – |
Primary outcome
Improvement of neuropathy by WEST assessment at 6, 12, 18, and 24 weeks
1 secondary outcome
Improved quality of life by Functional Assessment of Cancer Therapy-GOG/NTX (FACT-GOG/NTX) at 6, 12, 18, and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven C. Plaxe, MD study chair
University of California, San Diego
57 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing amifostine trihydrate in people with Gestational Trophoblastic Tumor and Neurotoxicity, run by Gynecologic Oncology Group at 57 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of neuropathy by WEST assessment at 6, 12, 18, and 24 weeks. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2013.