Breast CancerPhase 2NCT00078845
Amifostine in Treating Peripheral Neuropathy Caused by Paclitaxel in Patients With Solid Tumors
A Phase 2 study testing Amifostine in people with Breast Cancer and Lung Cancer, run by M.D. Anderson Cancer Center at 15 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Lung Cancer, Neurotoxicity
- What is being tested?
- Amifostine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 15 sitesUnited States
- Study dates
- May 2004to May 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Christus St. Frances Cabrini Center for Cancer Care
Alexandria, Louisiana, 71301
CCOP - Columbus
Columbus, Ohio, 43215
CCOP - Central Illinois
Decatur, Illinois, 62526
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503
University of Texas M.D. Anderson CCOP Research Base
Houston, Texas, 77030-4009
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
CCOP - Kansas City
Kansas City, Missouri, 64131
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, 54449
All Saints Cancer Center at Wheaton Franciscan Healthcare
Racine, Wisconsin, 53405
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
Cancer Research for the Ozarks
Springfield, Missouri, 65807
CCOP - Northwest
Tacoma, Washington, 98405-0986
CCOP - Scott and White Hospital
Temple, Texas, 76508
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
CCOP - Wichita
Wichita, Kansas, 67214-3882
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer, Lung Cancer, Neurotoxicity, Ovarian Cancer, Prostate Cancer, Unspecified Adult Solid Tumor, Protocol Specific
- Being tested
- Amifostine
- 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
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Neurotoxicity Syndromes, Ovarian Neoplasms, Prostatic Neoplasms, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmifostineDrug
Also called amifostine trihydrate
500 mg three times a week.
| Study group | Role | What they receive |
|---|---|---|
| Amifostine | Experimental | 500 mg subcutaneous three times a week on Monday, Wednesday and Friday for 4 weeks. Receives: Drug: Amifostine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurotoxicity secondary to cancer therapy as measured by FACT-GOG-NTX scale
11-item FACT/GOG-NTX questionnaire completed weekly following chemotherapy treatment.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2004 (estimated)
- Study startMay 2004
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Arthur Forman, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00078845
- Sponsor's protocol ID
- CDR0000330006
- Other IDs
- MDA-CCC-0223, MDA-CCC-0203, MDA-2003-0789
- Status last verified
- Oct 2012
- First submitted
- 8 Mar 2004
- Last updated
- 17 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial Of Subcutaneous Amifostine For Reversal Of Persistent Paclitaxel-Induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT00078845
- Acronym / sponsor ID
- CDR0000330006
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2004
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 9 Mar 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amifostine | Experimental | Drug: Amifostine500 mg subcutaneous three times a week on Monday, Wednesday and Friday for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmifostineAlso: amifostine trihydrate500 mg three times a week. | Drug | Amifostine |
Primary outcome
Neurotoxicity secondary to cancer therapy as measured by FACT-GOG-NTX scale
Time frame: 12 weeks
11-item FACT/GOG-NTX questionnaire completed weekly following chemotherapy treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arthur Forman, MD study chair
M.D. Anderson Cancer Center
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amifostine in people with Breast Cancer and Lung Cancer, run by M.D. Anderson Cancer Center at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurotoxicity secondary to cancer therapy as measured by FACT-GOG-NTX scale (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2012.