Completed

Phase II Trial Of Subcutaneous Amifostine For Reversal Of Persistent Paclitaxel-Induced Peripheral Neuropathy

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What is being tested

Amifostine

Drug
Who is being recruted

Urogenital Diseases+21

+ Genital Diseases

+ Breast Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Supportive Care Study

Phase 2
Interventional
Study Start: May 2004
See protocol details

Summary

Principal SponsorM.D. Anderson Cancer Center
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2004

Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Determine the percentage of patients with solid tumors who have persistent paclitaxel-induced peripheral neuropathy who benefit, defined as a decrease of at least 20% on their FUNCTIONAL ASSESSMENT OF CANCER THERAPY/ GYNECOLOGIC ONCOLOGY GROUP NEUROTOXICITY (FACT/GOG-Ntx) FACT-GOG-NTX score, from treatment with subcutaneous amifostine. * Determine whether there is sufficient evidence of reversal activity of this drug in these patients to justify a phase III study. Secondary * Compare the acute toxic effects of this drug administered subcutaneously in these patients vs IV administrations of this drug historically and/or during the GOG-0192 study. * Determine the capability of the Weinstein Enhanced Sensory Test to provide objective, quantitative evidence for improvement in patients who have subjective improvement as self-reported on the FACT-GOG-NTX scale. * Determine whether any benefit in patients treated with this drug is transient or lasts at least 8 weeks. OUTLINE: This is an open-label, multicenter study. Patients receive amifostine subcutaneously three times weekly for 4 weeks in the absence of symptom progression or unacceptable toxicity. Patients achieving a complete or partial response receive an additional 4 weeks of therapy. Neuropathy symptoms are assessed using the FACT-GOG-NTX questionnaire administered at baseline, weekly during therapy, and at 12 weeks and the Weinstein Enhanced Sensory Test administered at baseline and at 4, 8, and 12 weeks. Patients are followed at 12 weeks. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 10-20 months.

Official TitlePhase II Trial Of Subcutaneous Amifostine For Reversal Of Persistent Paclitaxel-Induced Peripheral Neuropathy 
NCT00078845
Principal SponsorM.D. Anderson Cancer Center
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

24 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesBreast DiseasesBreast NeoplasmsGenital Diseases, MaleGenital Neoplasms, MaleLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteNervous System DiseasesNeuromuscular DiseasesPeripheral Nervous System DiseasesPoisoningProstatic DiseasesProstatic NeoplasmsRespiratory Tract DiseasesRespiratory Tract NeoplasmsSkin DiseasesThoracic NeoplasmsUrogenital NeoplasmsNeurotoxicity SyndromesMale Urogenital DiseasesChemically-Induced Disorders

Criteria

DISEASE CHARACTERISTICS: * Diagnosis of a solid tumor, including, but not limited to the following: * Ovarian cancer * Lung cancer * Prostate cancer * Breast cancer * Previously treated with paclitaxel * Peripheral neuropathy (e.g., numbness, tingling, and/or pain in distal extremities) believed to be caused by paclitaxel only or the combination of paclitaxel and carboplatin * At least 18 out of 44 on the FACT-GOG-NTX scale * Persistent neuropathy for at least 2, but no more than 12 months after chemotherapy * Not improving * No other possible cause of neuropathy (e.g., alcoholism, diabetes, or peripheral vascular disease) * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Not specified Menopausal status * Not specified Performance status * Karnofsky 50-100% Life expectancy * More than 2 months Hematopoietic * Not specified Hepatic * Bilirubin ≤ 2.0 mg/dL Renal * Creatinine ≤ 2.0 mg/dL * Calcium ≥ lower limit of normal Cardiovascular * See Disease Characteristics * No prior cerebrovascular accident Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other significant comorbid medical condition that would preclude study participation * No known sensitivity to aminothiol compounds PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics * No prior cisplatin * No chemotherapy during and for at least 3 months after study participation Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * No concurrent monoamine oxidase inhibitors

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
500 mg subcutaneous three times a week on Monday, Wednesday and Friday for 4 weeks.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 15 locations

Suspended

CCOP - Central Illinois

Decatur, United StatesSee the location
Suspended

CCOP - Carle Cancer Center

Urbana, United States
Suspended

CCOP - Wichita

Wichita, United States
Suspended

Christus St. Frances Cabrini Center for Cancer Care

Alexandria, United States
Completed15 Study Centers