Breast CancerPhase 2NCT00004092
Combination Chemotherapy in Treating Patients With High-Risk Breast Cancer
A Phase 2 study testing filgrastim, carboplatin and cyclophosphamide in people with Breast Cancer, run by City of Hope Medical Center at 2 sites 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. PURPOSE: This randomized phase II trial is studying two different regimens of combination chemotherapy and comparing them to see how well they… Read more about this study
- Who is it for?
- Ages Up to 60 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- filgrastim, carboplatin and cyclophosphamide
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesUnited States
- Study dates
- May 1999to Dec 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS:
- Histologically proven high-risk primary breast cancer with less than 60% chance of progression-free survival of 3 years from diagnosis
- Stage II with at least 10 positive axillary nodes OR
- Stage IIIA or IIIB
- No histologically proven bone marrow metastasis
- No CNS metastasis
- Hormone receptor status:
- Hormone receptor status known
PATIENT CHARACTERISTICS:
Age:
- Physiological age 60 or under
Menopausal status:
- Not specified
Performance status:
- Karnofsky 80-100%
Life expectancy:
- See Disease Characteristics
Hematopoietic:
- Neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- SGOT or SGPT no greater than 2 times upper limit of normal
- Hepatitis B antigen negative
Renal:
- Creatinine no greater than 1.2 mg/dL
- Creatinine clearance at least 70 mL/min
- No prior hemorrhagic cystitis
Cardiovascular:
- Ejection fraction at least 55% by MUGA
- No prior significant valvular heart disease or arrhythmia
Pulmonary:
- FEV_1 at least 60% of predicted
- pO_2 at least 85 mm Hg on room air
- pCO_2 at least 43 mm Hg on room air
- DLCO at least 60% lower limit of predicted
Other:
- No other prior malignancy except squamous cell or basal cell skin cancer or stage I or carcinoma in situ of the cervix
- No CNS dysfunction that would preclude compliance
- HIV negative
- No sensitivity to E. coli-derived products
- Not pregnant
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 4 weeks since prior chemotherapy
- No prior doxorubicin of total dose exceeding 240 mg/m^2
- No prior paclitaxel of total dose of at least 750 mg/m^2
- No more than 12 months since prior conventional-dose adjuvant chemotherapy
Endocrine therapy:
- At least 4 weeks since prior hormonal therapy
Radiotherapy:
- At least 4 weeks since prior radiotherapy
- No prior radiation to the left chest wall
Surgery:
- Not specified
Trial locations and contacts
2 sites in 1 country.
United States2 sites
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
Banner Good Samaritan Medical Center
Phoenix, Arizona, 85006
About this study
Official title: Randomized Phase II Study of Adriamycin/Cytoxan/Taxol (ACT) vs. Cytoxan, Thiotepa, Carboplatin (STAMP V) in Patients With High-Risk Primary 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.
PURPOSE: This randomized phase II trial is studying two different regimens of combination chemotherapy and comparing them to see how well they work in treating patients with high-risk primary stage II or stage III breast cancer.
Read the detailed description
OBJECTIVES:
- Compare the toxic effects of doxorubicin, cyclophosphamide, and paclitaxel vs cyclophosphamide, thiotepa, and carboplatin in patients with high-risk primary breast cancer. (Arm I closed to accural as of 4/6/2006.)
- Compare the efficacies of these regimens followed by peripheral blood stem cell rescue in these patients.
- Determine the efficacy of a bisphosphonate to prevent relapse/metastasis after high-dose chemotherapy in these patients.
OUTLINE: This is a randomized study. Patients are stratified by stage of disease.
Peripheral blood stem cells (PBSC) are collected after mobilization with filgrastim (G-CSF), administered subcutaneously or IV, twice daily beginning 3 days before collection and continuing until collection is complete.
All patients receive conventional-dose adjuvant chemotherapy, probably comprising doxorubicin IV, cyclophosphamide IV, and fluorouracil IV over 1 hour on days 1, 22, 43, and 64. Patients are then randomized to receive 1 of 2 treatment arms of high-dose chemotherapy. (Arm I closed to accrual as of 4/6/2006.)
- Arm I (ACT) (closed to accrual as of 4/6/2006): Patients receive doxorubicin IV over 24 hours on days -9 to -6, cyclophosphamide IV over 2 hours on day -5, and paclitaxel IV over 24 hours on day -2. PBSC are reinfused on days -2 and 0. G-CSF is administered beginning on day 0 and continuing until blood counts recover.
- Arm II (STAMP V): Patients receive cyclophosphamide IV, carboplatin IV, and thiotepa IV over 24 hours on days -7 to -4. PBSC are reinfused and G-CSF is administered as in arm I.
Within 4-6 weeks of day 0 of high-dose chemotherapy, patients with estrogen and/or progesterone receptor positive tumors receive oral tamoxifen twice daily for 5 years. Patients are also randomized to receive a bisphosphonate comprising pamidronate IV every 4 weeks for 2 years.
Quality of life is assessed before therapy, at 30 days after high-dose chemotherapy, and at 6 and 12 months.
Patients are followed every 3 months for 1 year and then every 6 months for at least 10 years.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 3 years.
- Conditions
- Breast Cancer
- Being tested
- filgrastim, carboplatin, cyclophosphamide, doxorubicin hydrochloride, paclitaxel
- Keywords
- stage II breast cancer, stage IIIA breast cancer, stage IIIB 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.
filgrastimBiological
Given IV or subcutaneously
carboplatinDrug
Given IV
cyclophosphamideDrug
Given IV
Given IV
paclitaxelDrug
Given IV
thiotepaDrug
Given IV
peripheral blood stem cell transplantationProcedure or surgery
Patients receive autologous peripheral blood stem cells
| Study group | Role | What they receive |
|---|---|---|
| Arm I (ACT) (closed to accrual as of 4/6/2006) | Experimental | Patients receive doxorubicin IV over 24 hours on days -9 to -6, cyclophosphamide IV over 2 hours on day -5, and paclitaxel IV over 24 hours on day -2. PBSC are reinfused on days -2 and 0. G-CSF is administered beginning on day 0 and continuing until blood counts recover. Receives: Biological: filgrastim; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: paclitaxel; Procedure: peripheral blood stem cell transplantation |
| Arm II (STAMP V) | Active comparator | Patients receive cyclophosphamide IV, carboplatin IV, and thiotepa IV over 24 hours on days -7 to -4. PBSC are reinfused and G-CSF is administered as in arm I. Receives: Biological: filgrastim; Drug: carboplatin; Drug: cyclophosphamide; Drug: thiotepa; Procedure: peripheral blood stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Five-Year Relapse-free Survival
RFS events included death or disease recurrence. Patients who did not experience disease recurrence or death were censored at the date of last follow-up. Survival rates were estimates using the Kaplan-Meier method.
Measured: Five years
Secondary outcomes (1)
Five-Year Overall Survival
Patients who were still alive were censored at the date of last follow-up. Survival rates were estimates using the Kaplan-Meier method.
Measured: Five Years
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 1999
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by City of Hope Medical 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- George Somlo, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004092
- Sponsor's protocol ID
- 98096
- Other IDs
- U01CA063265, P30CA033572, CHNMC-IRB-98096, CHNMC-PHII-18, NCI-H99-0038, CDR0000067305
- Status last verified
- Jul 2015
- First submitted
- 10 Dec 1999
- Last updated
- 4 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study of Adriamycin/Cytoxan/Taxol (ACT) vs. Cytoxan, Thiotepa, Carboplatin (STAMP V) in Patients With High-Risk Primary Breast Cancer
- ClinicalTrials.gov ID
- NCT00004092
- Acronym / sponsor ID
- 98096
- Conditions
- Breast Cancer
- Keywords
- stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 1999
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Posted 4 Aug 2015
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.
PURPOSE: This randomized phase II trial is studying two different regimens of combination chemotherapy and comparing them to see how well they work in treating patients with high-risk primary stage II or stage III breast cancer.
Detailed description
OBJECTIVES:
- Compare the toxic effects of doxorubicin, cyclophosphamide, and paclitaxel vs cyclophosphamide, thiotepa, and carboplatin in patients with high-risk primary breast cancer. (Arm I closed to accural as of 4/6/2006.)
- Compare the efficacies of these regimens followed by peripheral blood stem cell rescue in these patients.
- Determine the efficacy of a bisphosphonate to prevent relapse/metastasis after high-dose chemotherapy in these patients.
OUTLINE: This is a randomized study. Patients are stratified by stage of disease.
Peripheral blood stem cells (PBSC) are collected after mobilization with filgrastim (G-CSF), administered subcutaneously or IV, twice daily beginning 3 days before collection and continuing until collection is complete.
All patients receive conventional-dose adjuvant chemotherapy, probably comprising doxorubicin IV, cyclophosphamide IV, and fluorouracil IV over 1 hour on days 1, 22, 43, and 64. Patients are then randomized to receive 1 of 2 treatment arms of high-dose chemotherapy. (Arm I closed to accrual as of 4/6/2006.)
- Arm I (ACT) (closed to accrual as of 4/6/2006): Patients receive doxorubicin IV over 24 hours on days -9 to -6, cyclophosphamide IV over 2 hours on day -5, and paclitaxel IV over 24 hours on day -2. PBSC are reinfused on days -2 and 0. G-CSF is administered beginning on day 0 and continuing until blood counts recover.
- Arm II (STAMP V): Patients receive cyclophosphamide IV, carboplatin IV, and thiotepa IV over 24 hours on days -7 to -4. PBSC are reinfused and G-CSF is administered as in arm I.
Within 4-6 weeks of day 0 of high-dose chemotherapy, patients with estrogen and/or progesterone receptor positive tumors receive oral tamoxifen twice daily for 5 years. Patients are also randomized to receive a bisphosphonate comprising pamidronate IV every 4 weeks for 2 years.
Quality of life is assessed before therapy, at 30 days after high-dose chemotherapy, and at 6 and 12 months.
Patients are followed every 3 months for 1 year and then every 6 months for at least 10 years.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (ACT) (closed to accrual as of 4/6/2006) | Experimental | Biological: filgrastim, Drug: cyclophosphamide, Drug: doxorubicin hydrochloride, Drug: paclitaxel, Procedure: peripheral blood stem cell transplantationPatients receive doxorubicin IV over 24 hours on days -9 to -6, cyclophosphamide IV over 2 hours on day -5, and paclitaxel IV over 24 hours on day -2. PBSC are reinfused on days -2 and 0. G-CSF is administered beginning on day 0 and continuing until blood counts recover. |
| Arm II (STAMP V) | Active comparator | Biological: filgrastim, Drug: carboplatin, Drug: cyclophosphamide, Drug: thiotepa, Procedure: peripheral blood stem cell transplantationPatients receive cyclophosphamide IV, carboplatin IV, and thiotepa IV over 24 hours on days -7 to -4. PBSC are reinfused and G-CSF is administered as in arm I. |
Who may qualify
- Ages
- Up to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| filgrastimGiven IV or subcutaneously | Biological | Arm I (ACT) (closed to accrual as of 4/6/2006), Arm II (STAMP V) |
| carboplatinGiven IV | Drug | Arm II (STAMP V) |
| cyclophosphamideGiven IV | Drug | Arm I (ACT) (closed to accrual as of 4/6/2006), Arm II (STAMP V) |
| doxorubicin hydrochlorideGiven IV | Drug | Arm I (ACT) (closed to accrual as of 4/6/2006) |
| paclitaxelGiven IV | Drug | Arm I (ACT) (closed to accrual as of 4/6/2006) |
| thiotepaGiven IV | Drug | Arm II (STAMP V) |
| peripheral blood stem cell transplantationPatients receive autologous peripheral blood stem cells | Procedure or surgery | Arm I (ACT) (closed to accrual as of 4/6/2006), Arm II (STAMP V) |
Primary outcome
Five-Year Relapse-free Survival
Time frame: Five years
RFS events included death or disease recurrence. Patients who did not experience disease recurrence or death were censored at the date of last follow-up. Survival rates were estimates using the Kaplan-Meier method.
1 secondary outcome
Five-Year Overall Survival
Time frame: Five Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
George Somlo, MD principal investigator
City of Hope Medical Center
2 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 filgrastim, carboplatin and cyclophosphamide in people with Breast Cancer, run by City of Hope Medical Center at 2 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 4 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 4 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Five-Year Relapse-free Survival (time frame: Five years). 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 4 Aug 2015.