Phase II Trial Of Subcutaneous Amifostine For Reversal Of Persistent Paclitaxel-Induced Peripheral Neuropathy
18 Years
N/A
Both
Breast Cancer, Lung Cancer, Neurotoxicity, Ovarian Cancer, Prostate Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Phase II Trial Of Subcutaneous Amifostine For Reversal Of Persistent Paclitaxel-Induced Peripheral Neuropathy
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Neurotoxicity secondary to cancer therapy as measured by FACT-GOG-NTX scale
Outcome Description:
11-item FACT/GOG-NTX questionnaire completed weekly following chemotherapy treatment.
Outcome Time Frame:
12 weeks
Safety Issue:
Yes
Principal Investigator
Arthur Forman, MD
Investigator Role:
Study Chair
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
CDR0000330006
NCT ID:
NCT00078845
Start Date:
May 2004
Completion Date:
May 2007
Related Keywords:
- Breast Cancer
- Lung Cancer
- Neurotoxicity
- Ovarian Cancer
- Prostate Cancer
- Unspecified Adult Solid Tumor, Protocol Specific
- neurotoxicity
- unspecified adult solid tumor, protocol specific
- recurrent prostate cancer
- stage I prostate cancer
- stage IIB prostate cancer
- stage IIA prostate cancer
- stage III prostate cancer
- stage IV prostate cancer
- recurrent non-small cell lung cancer
- stage I non-small cell lung cancer
- stage II non-small cell lung cancer
- stage IIIA non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- stage IV non-small cell lung cancer
- limited stage small cell lung cancer
- extensive stage small cell lung cancer
- recurrent small cell lung cancer
- recurrent breast cancer
- stage I breast cancer
- stage II breast cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- stage IV breast cancer
- recurrent ovarian epithelial cancer
- stage I ovarian epithelial cancer
- stage II ovarian epithelial cancer
- stage III ovarian epithelial cancer
- stage IV ovarian epithelial cancer
- Breast Neoplasms
- Lung Neoplasms
- Ovarian Neoplasms
- Peripheral Nervous System Diseases
- Prostatic Neoplasms
- Neurotoxicity Syndromes
- Neoplasms
Name | Location |
|---|---|
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| CCOP - Kansas City | Kansas City, Missouri 64131 |
| CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
| CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
| CCOP - Central Illinois | Springfield, Illinois 62526 |
| Cancer Research for the Ozarks | Springfield, Missouri 65807 |
| CCOP - Columbus | Columbus, Ohio 43206 |
| CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
| CCOP - Scott and White Hospital | Temple, Texas 76508 |
| CCOP - Northwest | Tacoma, Washington 98405-0986 |
| CCOP - Marshfield Clinic Research Foundation | Marshfield, Wisconsin 54449 |
| All Saints Cancer Center at Wheaton Franciscan Healthcare | Racine, Wisconsin 53405 |
| Christus St. Frances Cabrini Center for Cancer Care | Alexandria, Louisiana 71301 |
| University of Texas M.D. Anderson CCOP Research Base | Houston, Texas 77030-4009 |
