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Amifostine in Treating Peripheral Neuropathy Caused by Paclitaxel in Patients With Solid Tumors
This study has been completed.
Study NCT00078845   Information provided by National Cancer Institute (NCI)
First Received: March 8, 2004   Last Updated: May 9, 2009   History of Changes

March 8, 2004
May 9, 2009
May 2004
 
Neurotoxicity secondary to cancer therapy as measured by FACT-GOG-NTX scale
Same as current
Complete list of historical versions of study NCT00078845 on ClinicalTrials.gov Archive Site
 
 
 
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

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

  • 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 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.

Phase II
Interventional
Supportive Care, Open Label
  • Breast Cancer
  • Lung Cancer
  • Neurotoxicity
  • Ovarian Cancer
  • Prostate Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
Drug: amifostine trihydrate
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
40
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00078845
 
CDR0000330006, MDA-CCC-0223, MDA-CCC-0203, MDA-2003-0789
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Arthur Forman, MD M.D. Anderson Cancer Center
National Cancer Institute (NCI)
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP