Breast CancerPhase 2NCT00006260
Combination Chemotherapy in Treating Patients With Metastatic Breast Cancer
A Phase 2 study testing cisplatin, etoposide and ifosfamide in people with Breast Cancer, run by Case Comprehensive Cancer Center 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. Combining more than one drug may kill more tumor cells. Drugs such as mesna may be effective in preventing some of the side effects of chemotherapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer
- What is being tested?
- cisplatin, etoposide and ifosfamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- May 1997to Jan 2005
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically proven progressive metastatic breast cancer
- Measurable disease
- Any lesion measurable in 2 dimensions
- Hepatic metastases if the sum of the measurements below the costal margin in the midclavicular line and the tip to the xiphoid process is greater than 5 cm during quiet respiration
- Hepatic defects that are clearly measurable by radionuclide, CAT, or MRI scans
- Bone metastases are not considered measurable disease
- Evaluable disease allowed if measurable disease also present
- No brain metastases, carcinomatous meningitis, or spinal cord compression
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- Not specified
Menopausal status:
- Not specified
Performance status:
- ECOG 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- Hemoglobin at least 10 g/dL
- WBC at least 4,000/mm3
- Platelet count at least 100,000/mm3
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
Renal:
- Creatinine no greater than 1.5 mg/dL
- No bladder outlet obstruction
Cardiovascular:
- No symptomatic cardiovascular disease (e.g., congestive heart disease) or inability to tolerate a fluid load
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active infection
- No prior malignancies except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No greater than 1 prior biologic response modifier treatment for metastatic disease
Chemotherapy:
- No greater than 1 prior chemotherapy regimen for metastatic disease allowed
- Patients who relapsed during or within 6 months after adjuvant chemotherapy are considered to have failed 1 regimen
- Patients who relapsed more than 6 months after adjuvant chemotherapy are considered to not have had a prior regimen
- Greater than 4 weeks since prior chemotherapy (greater than 6 weeks for mitomycin or nitrosoureas) and recovered
- No prior cisplatin, etoposide, or ifosfamide
Endocrine therapy:
- Prior medical or surgical hormonal therapy allowed
Radiotherapy:
- Prior radiation therapy to areas of measurable disease allowed if indicator lesion increased in size by greater than 25% after treatment
- Recovered from effects of prior radiotherapy
Surgery:
- Recovered from effects of major surgery
Other:
- At least 7 days since prior nephrotoxic drugs (e.g., aminoglycosides, diuretics, lithium, intravenous contrast, or nonsteroidal antiinflammatory drugs)
Trial locations and contacts
1 site in 1 country.
United States1 site
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5055
About this study
Official title: A Phase II Study Of An OutPatient Three Day VIP Regimen With Oral Mesna For Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Drugs such as mesna may be effective in preventing some of the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of etoposide and ifosfamide given with mesna, and cisplatin in treating patients who have metastatic breast cancer.
Read the detailed description
OBJECTIVES:
- Determine the objective response rate in patients with metastatic breast cancer treated with etoposide, ifosfamide with mesna, and cisplatin.
- Determine the tolerability and toxicity of this regimen in these patients.
OUTLINE: Patients are stratified according to number of prior chemotherapy courses for metastatic disease (0 vs 1).
Patients receive etoposide IV over 60-90 minutes, cisplatin IV over 30 minutes, and ifosfamide IV over 30 minutes on days 1-3. Mesna is administered IV over 15 minutes 30 minutes prior to and 4 hours after ifosfamide, then orally at 8 hours post infusion. Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months.
PROJECTED ACCRUAL: At least 36 patients (16 per stratum) will be accrued over 36 months.
- Conditions
- Breast Cancer
- Being tested
- cisplatin, etoposide, ifosfamide, Mesna
- Keywords
- stage IV breast cancer, recurrent breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatinDrug
cisplatin IV over 30 minutes on days 1-3.
etoposideDrug
etoposide IV over 60-90 minutes on days 1-3.
ifosfamideDrug
ifosfamide IV over 30 minutes on days 1-3.
MesnaDrug
Mesna is administered IV over 15 minutes 30 minutes prior to and 4 hours after ifosfamide, then orally at 8 hours post infusion.
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the objective response rate in patients with metastatic breast cancer treated with etoposide, ifosfamide with mesna, and cisplatin.
Measured: Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMay 1997
- Primary completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Scot C. Remick, MD, Principal investigator, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006260
- Sponsor's protocol ID
- CWRU4196
- Other IDs
- P30CA043703, CWRU-4196, BMS-CRWU-4196, NCI-G00-1854
- Status last verified
- Jun 2010
- First submitted
- 11 Sep 2000
- Last updated
- 11 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Viana LV, Leitao CB, Grillo MF, Rocha EP, Brenner JK, Friedman R, Gross JL. Hypertension management algorithm for type 2 diabetic patients applied in primary care. Diabetol Metab Syndr. 2013 Sep 12;5(1):52. doi: 10.1186/1758-5996-5-52.
PubMed 24028306
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Of An OutPatient Three Day VIP Regimen With Oral Mesna For Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00006260
- Acronym / sponsor ID
- CWRU4196
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer, recurrent breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 1997
- Primary completion
- Jan 2005 (actual)
- First posted
- 27 Jan 2003 (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. Combining more than one drug may kill more tumor cells. Drugs such as mesna may be effective in preventing some of the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of etoposide and ifosfamide given with mesna, and cisplatin in treating patients who have metastatic breast cancer.
Detailed description
OBJECTIVES:
- Determine the objective response rate in patients with metastatic breast cancer treated with etoposide, ifosfamide with mesna, and cisplatin.
- Determine the tolerability and toxicity of this regimen in these patients.
OUTLINE: Patients are stratified according to number of prior chemotherapy courses for metastatic disease (0 vs 1).
Patients receive etoposide IV over 60-90 minutes, cisplatin IV over 30 minutes, and ifosfamide IV over 30 minutes on days 1-3. Mesna is administered IV over 15 minutes 30 minutes prior to and 4 hours after ifosfamide, then orally at 8 hours post infusion. Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months.
PROJECTED ACCRUAL: At least 36 patients (16 per stratum) will be accrued over 36 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| cisplatincisplatin IV over 30 minutes on days 1-3. | Drug | – |
| etoposideetoposide IV over 60-90 minutes on days 1-3. | Drug | – |
| ifosfamideifosfamide IV over 30 minutes on days 1-3. | Drug | – |
| MesnaMesna is administered IV over 15 minutes 30 minutes prior to and 4 hours after ifosfamide, then orally at 8 hours post infusion. | Drug | – |
Primary outcome
Determine the objective response rate in patients with metastatic breast cancer treated with etoposide, ifosfamide with mesna, and cisplatin.
Time frame: Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression.
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 11 Jun 2010.
- Derived from this study: PubMed 24028306Viana LV, Leitao CB, Grillo MF, Rocha EP, Brenner JK, Friedman R, Gross JL. Hypertension management algorithm for type 2 diabetic patients applied in primary care. Diabetol Metab Syndr. 2013 Sep 12;5(1):52. doi: 10.1186/1758-5996-5-52.
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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.
Scot C. Remick, MD principal investigator
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive 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 2 study testing cisplatin, etoposide and ifosfamide in people with Breast Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2010. 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 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?
Determine the objective response rate in patients with metastatic breast cancer treated with etoposide, ifosfamide with mesna, and cisplatin. (time frame: Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00006260, which also lists 1 linked publication.
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 11 Jun 2010.