Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MDA-CCC-0223 | |||
| MDA-CCC-0203 | |||
| MDA-2003-0789 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
OBJECTIVES:
Primary
Secondary
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amifostine | Experimental | 500 mg subcutaneous three times a week on Monday, Wednesday and Friday for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amifostine | Drug | 500 mg three times a week. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Neurotoxicity secondary to cancer therapy as measured by FACT-GOG-NTX scale | 11-item FACT/GOG-NTX questionnaire completed weekly following chemotherapy treatment. | 12 weeks |
Not provided
Not provided
DISEASE CHARACTERISTICS:
Diagnosis of a solid tumor, including, but not limited to the following:
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
No other possible cause of neuropathy (e.g., alcoholism, diabetes, or peripheral vascular disease)
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Arthur Forman, MD | M.D. Anderson Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CCOP - Central Illinois | Decatur | Illinois | 62526 | United States | ||
| CCOP - Carle Cancer Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Urbana |
| Illinois |
| 61801 |
| United States |
| CCOP - Wichita | Wichita | Kansas | 67214-3882 | United States |
| Christus St. Frances Cabrini Center for Cancer Care | Alexandria | Louisiana | 71301 | United States |
| CCOP - Grand Rapids | Grand Rapids | Michigan | 49503 | United States |
| CCOP - Kalamazoo | Kalamazoo | Michigan | 49007-3731 | United States |
| CCOP - Kansas City | Kansas City | Missouri | 64131 | United States |
| Cancer Research for the Ozarks | Springfield | Missouri | 65807 | United States |
| CCOP - Columbus | Columbus | Ohio | 43215 | United States |
| CCOP - Upstate Carolina | Spartanburg | South Carolina | 29303 | United States |
| University of Texas M.D. Anderson CCOP Research Base | Houston | Texas | 77030-4009 | United States |
| CCOP - Scott and White Hospital | Temple | Texas | 76508 | United States |
| CCOP - Northwest | Tacoma | Washington | 98405-0986 | United States |
| CCOP - Marshfield Clinic Research Foundation | Marshfield | Wisconsin | 54449 | United States |
| All Saints Cancer Center at Wheaton Franciscan Healthcare | Racine | Wisconsin | 53405 | United States |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D008175 | Lung Neoplasms |
| D020258 | Neurotoxicity Syndromes |
| D010051 | Ovarian Neoplasms |
| D011471 | Prostatic Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D055752 | Small Cell Lung Carcinoma |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009422 | Nervous System Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D004999 | Amifostine |
| ID | Term |
|---|---|
| D063086 | Organothiophosphates |
| D010755 | Organophosphates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D009946 | Organothiophosphorus Compounds |
| D013457 | Sulfur Compounds |
Not provided
Not provided