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Phase II Trial Of Subcutaneous Amifostine For Reversal Of Persistent Paclitaxel-Induced Peripheral Neuropathy


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer, Lung Cancer, Neurotoxicity, Ovarian Cancer, Prostate Cancer, Unspecified Adult Solid Tumor, Protocol Specific

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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 CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Central IllinoisSpringfield, Illinois  62526
Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - ColumbusColumbus, Ohio  43206
CCOP - Grand RapidsGrand Rapids, Michigan  49503
CCOP - Scott and White HospitalTemple, Texas  76508
CCOP - NorthwestTacoma, Washington  98405-0986
CCOP - Marshfield Clinic Research FoundationMarshfield, Wisconsin  54449
All Saints Cancer Center at Wheaton Franciscan HealthcareRacine, Wisconsin  53405
Christus St. Frances Cabrini Center for Cancer CareAlexandria, Louisiana  71301
University of Texas M.D. Anderson CCOP Research BaseHouston, Texas  77030-4009