Amifostine in Treating Peripheral Neuropathy in Patients Who Have Received Chemotherapy for Cancer - Full Text View

Sponsor:	Gynecologic Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00058071

Purpose

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.

Condition	Intervention	Phase
Gestational Trophoblastic Tumor Neurotoxicity Unspecified Adult Solid Tumor, Protocol Specific	Drug: amifostine trihydrate	Phase III

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Active Control
Official Title:	A Randomized Phase III Trial of Amifostine vs. No Treatment for Platinum Induced Peripheral Neuropathy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Peripheral Nerve Disorders

Drug Information available for: Amifostine

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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

Secondary Outcome Measures:

Improved quality of life by Functional Assessment of Cancer Therapy-GOG/NTX (FACT-GOG/NTX) at 6, 12, 18, and 24 weeks

Estimated Enrollment:	100
Study Start Date:	March 2003
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00058071

Show 57 Study Locations

Sponsors and Collaborators

Gynecologic Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Steven C. Plaxe, MD

University of California, San Diego

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000285700, GOG-0192
Study First Received:	April 7, 2003
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00058071 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

neurotoxicity
hydatidiform mole
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:

Radiation-Protective Agents
Neoplasms by Histologic Type
Pregnancy Complications, Neoplastic
Pregnancy Complications
Amifostine
Neurotoxicity Syndromes
Physiological Effects of Drugs
Nervous System Diseases
Poisoning

Disorders of Environmental Origin
Protective Agents
Pharmacologic Actions
Neoplasms
Neuromuscular Diseases
Peripheral Nervous System Diseases
Gestational Trophoblastic Neoplasms
Neoplasms, Germ Cell and Embryonal
Trophoblastic Neoplasms

ClinicalTrials.gov processed this record on November 09, 2009