Clinical trial NCT00078845: Amifostine in Treating Peripheral Neuropathy Caused by Paclitaxel in Patients With Solid Tumors
Official title: Phase II Trial Of Subcutaneous Amifostine For Reversal Of Persistent Paclitaxel-Induced Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lung Cancer
Neurotoxicity
Ovarian Cancer
Prostate Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: 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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-03-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Neurotoxicity secondary to cancer therapy as measured by FACT-GOG-NTX scale
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Decatur
country: United States
facility: CCOP - Central Illinois
state: Illinois
city: Urbana
country: United States
facility: CCOP - Carle Cancer Center
state: Illinois
city: Wichita
country: United States
facility: CCOP - Wichita
state: Kansas
city: Alexandria
country: United States
facility: Christus St. Frances Cabrini Center for Cancer Care
state: Louisiana
city: Grand Rapids
country: United States
facility: CCOP - Grand Rapids
state: Michigan
city: Kalamazoo
country: United States
facility: CCOP - Kalamazoo
state: Michigan
city: Kansas City
country: United States
facility: CCOP - Kansas City
state: Missouri
city: Springfield
country: United States
facility: Cancer Research for the Ozarks
state: Missouri
city: Columbus
country: United States
facility: CCOP - Columbus
state: Ohio
city: Spartanburg
country: United States
facility: CCOP - Upstate Carolina
state: South Carolina
city: Houston
country: United States
facility: University of Texas M.D. Anderson CCOP Research Base
state: Texas
city: Temple
country: United States
facility: CCOP - Scott and White Hospital
state: Texas
city: Tacoma
country: United States
facility: CCOP - Northwest
state: Washington
city: Marshfield
country: United States
facility: CCOP - Marshfield Clinic Research Foundation
state: Wisconsin
city: Racine
country: United States
facility: All Saints Cancer Center at Wheaton Franciscan Healthcare
state: Wisconsin
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Arthur Forman, MD
role: STUDY_CHAIR
References: