Ovarian CancerPhase 3NCT00004166
Amifostine in Treating Patients With Ovarian Epithelial Cancer Who Are Receiving Chemotherapy
A Phase 3 study testing amifostine trihydrate and quality-of-life assessment in people with Ovarian Cancer and Quality of Life, run by Northwestern University at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Quality of Life
- What is being tested?
- amifostine trihydrate and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Oct 1999to Jan 2003
- Phase
- Phase 3
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically confirmed, surgically staged ovarian epithelial cancer Planned treatment with paclitaxel/carboplatinum chemotherapy
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 3 mg/dL SGOT/SGPT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 2 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics Other: At least 24 hours since prior antihypertensives
Trial locations and contacts
1 site in 1 country.
United States1 site
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611
About this study
Official title: Amifostine as a Toxicity Protectant in Ovarian Cancer in Chemotherapy Treated Patients: A Pilot Phase III Randomized Controlled Trial
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy.
PURPOSE: Randomized phase III trial to study the effectiveness of amifostine in treating patients who have ovarian epithelial cancer and who are receiving chemotherapy.
Read the detailed description
OBJECTIVES: I. Determine if patients with ovarian epithelial cancer receiving chemotherapy have significantly fewer neurologic events when treated with amifostine. II. Compare amifostine vs no chemoprotection in terms of overall incidence of neuropathy, incidence of neutropenia, infection, and other myelosuppressive events (e.g., leukopenia, anemia, and thrombocytopenia), length of hospital stay due to infections, and quality of life in this patient population.
OUTLINE: This is a randomized, parallel, controlled, double blind study. Patients are randomized to one of two treatment arms. Arm I: Patients receive amifostine IV over 10 minutes, 30 minutes prior to chemotherapy. Arm II: Patients receive a placebo IV over 10 minutes, 30 minutes prior to chemotherapy. Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed prior to courses 1, 4, and 8, and then every 3 months for 1 year. Patients are followed monthly for 6 months.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 2 years.
- Conditions
- Ovarian Cancer, Quality of Life
- Being tested
- amifostine trihydrate, quality-of-life assessment
- Keywords
- stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, quality of life
- Medical subject headings
- Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amifostine trihydrateDrug
quality-of-life assessmentProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2004 (estimated)
- Study startOct 1999
- Primary completionJan 2003
- Study completionJan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- David A. Fishman, MD, Study chair, Robert H. Lurie Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004166
- Sponsor's protocol ID
- NU 97CC4
- Other IDs
- NU-97CC4, NCI-G99-1633
- Status last verified
- May 2012
- First submitted
- 10 Dec 1999
- Last updated
- 6 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amifostine as a Toxicity Protectant in Ovarian Cancer in Chemotherapy Treated Patients: A Pilot Phase III Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00004166
- Acronym / sponsor ID
- NU 97CC4
- Conditions
- Ovarian Cancer, Quality of Life
- Keywords
- stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, quality of life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 1999
- Primary completion
- Jan 2003 (actual)
- Study completion
- Jan 2003 (actual)
- First posted
- 12 Apr 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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy.
PURPOSE: Randomized phase III trial to study the effectiveness of amifostine in treating patients who have ovarian epithelial cancer and who are receiving chemotherapy.
Detailed description
OBJECTIVES: I. Determine if patients with ovarian epithelial cancer receiving chemotherapy have significantly fewer neurologic events when treated with amifostine. II. Compare amifostine vs no chemoprotection in terms of overall incidence of neuropathy, incidence of neutropenia, infection, and other myelosuppressive events (e.g., leukopenia, anemia, and thrombocytopenia), length of hospital stay due to infections, and quality of life in this patient population.
OUTLINE: This is a randomized, parallel, controlled, double blind study. Patients are randomized to one of two treatment arms. Arm I: Patients receive amifostine IV over 10 minutes, 30 minutes prior to chemotherapy. Arm II: Patients receive a placebo IV over 10 minutes, 30 minutes prior to chemotherapy. Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed prior to courses 1, 4, and 8, and then every 3 months for 1 year. Patients are followed monthly for 6 months.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 2 years.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- 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 |
|---|---|---|
| amifostine trihydrate | Drug | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 6 Jun 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.
David A. Fishman, MD study chair
Robert H. Lurie Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing amifostine trihydrate and quality-of-life assessment in people with Ovarian Cancer and Quality of Life, run by Northwestern University at 1 site 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 6 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
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 6 Jun 2012.