Clinical trial · Interventional
Amifostine in Treating Peripheral Neuropathy Caused by Paclitaxel in Patients With Solid Tumors
Phase II Trial Of Subcutaneous Amifostine For Reversal Of Persistent Paclitaxel-Induced Peripheral Neuropathy
NCT00078845CI-TRIAL-00008285completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Amifostine may be effective in reducing pain, numbness, tingling, and other symptoms of peripheral neuropathy. PURPOSE: This phase II trial is studying how well amifostine works in reducing pain, numbness, tingling, and other symptoms of peripheral neuropathy in patients who have received paclitaxel for solid tumors.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Neurotoxicity | — | UNRESOLVED | — |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Amifostine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Amifostine
- description
- 500 mg subcutaneous three times a week on Monday, Wednesday and Friday for 4 weeks.
- interventionNames
- Drug: Amifostine
Primary outcomes (1)
- measure
- Neurotoxicity secondary to cancer therapy as measured by FACT-GOG-NTX scale
- timeFrame
- 12 weeks
- description
- 11-item FACT/GOG-NTX questionnaire completed weekly following chemotherapy treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.