Amifostine in Treating Peripheral Neuropathy Caused by Paclitaxel in Patients With Solid Tumors

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00078845
First received: March 8, 2004
Last updated: October 16, 2012
Last verified: October 2012

March 8, 2004
October 16, 2012
May 2004
May 2007   (final data collection date for primary outcome measure)
Neurotoxicity secondary to cancer therapy as measured by FACT-GOG-NTX scale [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
11-item FACT/GOG-NTX questionnaire completed weekly following chemotherapy treatment.
Not Provided
Complete list of historical versions of study NCT00078845 on ClinicalTrials.gov Archive Site
Not Provided
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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 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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Breast Cancer
  • Lung Cancer
  • Neurotoxicity
  • Ovarian Cancer
  • Prostate Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
Drug: Amifostine
500 mg three times a week.
Other Name: amifostine trihydrate
Experimental: Amifostine
500 mg subcutaneous three times a week on Monday, Wednesday and Friday for 4 weeks.
Intervention: Drug: Amifostine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
May 2007
May 2007   (final data collection date for primary outcome measure)

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
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Arthur Forman, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
October 2012

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