Breast CancerPhase 2NCT00007904
Adjuvant Stage 2-3A Breast Cancer With Positive Lymph Nodes
A Phase 2 study testing filgrastim, cyclophosphamide and doxorubicin hydrochloride in people with Breast Cancer, run by Case Comprehensive Cancer Center at 3 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. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- filgrastim, cyclophosphamide and doxorubicin hydrochloride
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2000to Sep 2012
- 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:
- Histologically confirmed stage II or IIIA breast cancer
- At least 5 axillary lymph nodes
- No T4 or N3 disease
- No distant metastases by CT scan of the chest, abdomen, and pelvis; bone scan; and bone marrow evaluation
- No more than 8 weeks since prior lumpectomy or mastectomy with axillary node dissection
- Negative surgical margins
- Hormone receptor status:
- Hormone receptor status known
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex:
- Male or female
Menopausal status:
- Not specified
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,500/mm^3
- Granulocyte count at least 1,500/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGOT no greater than 1.5 times ULN
- Alkaline phosphatase no greater than 1.5 times ULN
Renal:
- Creatinine no greater than 1.5 mg/dL
Cardiovascular:
- No poorly controlled ischemic heart disease or congestive heart failure
Pulmonary:
- No severe chronic obstructive or restrictive pulmonary disease
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No severe diabetes mellitus
- No other severe concurrent medical or psychiatric illness that would preclude study participation
- No other malignancy within past 5 years except curatively treated ductal carcinoma in situ, lobular carcinoma in situ, or breast cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy
Surgery:
- See Disease Characteristics
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
UH-LUICC
Mentor, Ohio, 44060
UH-Chagrin Highlands
Orange, Ohio, 44122
About this study
Official title: A Phase II Study Of Safety And Tolerability Of Adjuvant Chemotherapy With Continuous Infusion Paclitaxel And Dose Intense Cyclophosphamide And Hematopoietic Growth Factor Support Followed By Doxorubicin For Stage II-IIIA Breast Cancer Involving Greater Than or Equal to 10 Lymph Nodes
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. Radiation therapy uses high-energy x-rays to damage tumor cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with filgrastim and radiation therapy works in treating patients with stage II or stage IIIA breast cancer.
Read the detailed description
OBJECTIVES:
- Determine the feasibility of administering adjuvant paclitaxel, dose-intensive cyclophosphamide, and filgrastim (G-CSF), followed by doxorubicin and then radiotherapy in patients with stage II or IIIA breast cancer involving > 4 lymph nodes.
- Determine the incidence of febrile neutropenia in these patients during the first course of therapy.
- Compare the incidence of febrile neutropenia and duration of neutropenia in patients treated with this regimen with that seen in patients treated on protocol CWRU-4194.
- Determine the disease-free and overall survival of patients treated with this regimen.
- Evaluate the quality of life of these patients.
- Correlate HER-2/neu overexpression with disease-free and overall survival in these patients.
OUTLINE: Patients receive paclitaxel IV continuously and cyclophosphamide IV over 2 hours on days 1-3. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 5 and continuing until day 14 or until blood counts recover. Treatment repeats every 21 days for 3 courses. Patients then receive doxorubicin IV on day 1 and G-CSF SC on days 2-11 every 21 days for 4 courses.
Patients with hormone receptor positive disease also receive oral tamoxifen daily for 5 years beginning at the completion of chemotherapy.
Beginning 3-6 weeks after the completion of chemotherapy, patients receive radiotherapy 5 days a week for 6-7 weeks.
Quality of life is assessed days 1 and 4 of the first course of chemotherapy, day 1 of the second course, the last day of the final course, and at 6 months after the completion of treatment.
Patients are followed every 3 months for 2 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- filgrastim, cyclophosphamide, doxorubicin hydrochloride, paclitaxel, tamoxifen citrate
- Keywords
- stage II breast cancer, stage IIIA breast cancer, male breast cancer
- Medical subject headings
- Breast Neoplasms, Breast Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
Also called G-CSF, Neupogen®, recominant-methionyl human granulocyte-colony stimulating factor, granulocyte colony stimulating factor, r-methHuG-CSF
Neupogen (G-CSF) given at a dose of 10 ugm/kg subcutaneously starting on day 5 and continuing until ANC > 10,000/uL x1 day after the nadir cycles 1-3.
cyclophosphamideDrug
Also called Cytoxan®, CTX, CPM, Neosar®
cyclophosphamide 700 mg/m2 daily for 3 day every 3 weeks cycles 1-3
Patients then receive doxorubicin IV on day 1.
paclitaxelDrug
Also called Taxol®
Paclitaxel 160 mg/m2 given over 72 hours by continuous infusion days 1-3
tamoxifen citrateDrug
tamoxifen at a dose of 20 mg daily for 5 years after chemotherapy is completed
adjuvant therapyProcedure or surgery
Patients receive paclitaxel IV continuously and cyclophosphamide IV over 2 hours on days 1-3. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 5 and continuing until day 14 or until blood counts recover. Treatment repeats every 21 days for 3 courses. Patients then receive doxorubicin IV on day 1 and G-CSF SC on days 2-11 every 21 days for 4 courses.
radiation therapyRadiation
Beginning 3-6 weeks after the completion of chemotherapy, patients receive radiotherapy 5 days a week for 6-7 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Combination Chemotherapy | Experimental | Paclitaxel IV continuously over 72 hours on days 1-3 and cyclophosphamide IV on days 1-3. Filgrastim subcutaneously (SC) beginning on day 5 and continuing until blood counts recover or pegfilgrastim SC on day 5. Treatment repeats every 21 days for 3 courses. Then doxorubicin hydrochloride IV on day 1 and filgrastim SC beginning on day 2 and continuing until blood counts recover or pegfilgrastim SC on day 2. Treatment repeats every 21 days for 4 courses. Patients with hormone-receptor positive tumors receive oral tamoxifen citrate or oral anastrozole daily for 5 years following chemotherapy. Beginning 3-6 weeks after completion of chemotherapy, patients undergo radiation therapy 5 days a week for 6-7 weeks. Receives: Biological: filgrastim; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: paclitaxel; Drug: tamoxifen citrate; Procedure: adjuvant therapy; Radiation: radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety of administering continuous infusion paclitaxel with dose intense cyclophosphamide
Paclitaxel 160 mg/m2 given over 72 hours by continuous infusion days 1-3 given concurrently with cyclophosphamide 700 mg/m2 daily for 3 day every 3 weeks cycles 1-3. Patients will be observed in the outpatient treatment area during the first 2 hours of the paclitaxel infusion for allergic reactions. Epinephrine, hydrocortisone, and IV antihistamine will be available.
Measured: 9 weeks
To determine the incidence of febrile neutropenia with the first cycle of therapy.
A specific objective of this trial is to estimate the incidence of febrile neutropenia. The observed incidence of febrile neutropenia with the first cycle of cyclophosphamide and paclitaxel, as well as the observed number of days of grade ¾ neutropenia during the first treatment cycle, will be reported along with 95% confidence intervals.
Measured: 3 weeks
Secondary outcomes (5)
To determine days of neutrophil counts below 500/uL on this regimen during the first treatment cycle.
Measured: after 1st cycle (3 weeks)
To evaluate dose delays and dose reductions of this regimen.
Measured: at 7 cycles (21 weeks)
To determine disease-free and overall survival of this regimen.
Measured: 5 yrs after treatment
Quality of life as assessed by Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire
Quality of life will be assessed using the FACT-B instrument. Quality of life will be assessed at the following timepoints: Cycle 1 day 1, Cycle 1 day 4, Cycle 2 day 1, on the final day of adriamycin, and 6 months after treatment is completed.
Measured: 6 months after treatment
Correlation of Her2/neu overexpression with disease-free and overall survival
Measured: 5 yrs after treatment
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 startJul 2000
- Primary completionJun 2006
- Study completionSep 2012
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 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Brenda W. Cooper, MD, Study chair, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00007904
- Sponsor's protocol ID
- CWRU1100
- Other IDs
- P30CA043703, 05-00-23, NCI-G00-1877, CWRU1100, NCI-2010-01068
- Status last verified
- Sep 2012
- First submitted
- 6 Jan 2001
- Last updated
- 2 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Of Safety And Tolerability Of Adjuvant Chemotherapy With Continuous Infusion Paclitaxel And Dose Intense Cyclophosphamide And Hematopoietic Growth Factor Support Followed By Doxorubicin For Stage II-IIIA Breast Cancer Involving Greater Than or Equal to 10 Lymph Nodes
- ClinicalTrials.gov ID
- NCT00007904
- Acronym / sponsor ID
- CWRU1100
- Conditions
- Breast Cancer
- Keywords
- stage II breast cancer, stage IIIA breast cancer, male breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2000
- Primary completion
- Jun 2006 (actual)
- Study completion
- Sep 2012 (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. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. Radiation therapy uses high-energy x-rays to damage tumor cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with filgrastim and radiation therapy works in treating patients with stage II or stage IIIA breast cancer.
Detailed description
OBJECTIVES:
- Determine the feasibility of administering adjuvant paclitaxel, dose-intensive cyclophosphamide, and filgrastim (G-CSF), followed by doxorubicin and then radiotherapy in patients with stage II or IIIA breast cancer involving > 4 lymph nodes.
- Determine the incidence of febrile neutropenia in these patients during the first course of therapy.
- Compare the incidence of febrile neutropenia and duration of neutropenia in patients treated with this regimen with that seen in patients treated on protocol CWRU-4194.
- Determine the disease-free and overall survival of patients treated with this regimen.
- Evaluate the quality of life of these patients.
- Correlate HER-2/neu overexpression with disease-free and overall survival in these patients.
OUTLINE: Patients receive paclitaxel IV continuously and cyclophosphamide IV over 2 hours on days 1-3. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 5 and continuing until day 14 or until blood counts recover. Treatment repeats every 21 days for 3 courses. Patients then receive doxorubicin IV on day 1 and G-CSF SC on days 2-11 every 21 days for 4 courses.
Patients with hormone receptor positive disease also receive oral tamoxifen daily for 5 years beginning at the completion of chemotherapy.
Beginning 3-6 weeks after the completion of chemotherapy, patients receive radiotherapy 5 days a week for 6-7 weeks.
Quality of life is assessed days 1 and 4 of the first course of chemotherapy, day 1 of the second course, the last day of the final course, and at 6 months after the completion of treatment.
Patients are followed every 3 months for 2 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm A: Combination Chemotherapy | Experimental | Biological: filgrastim, Drug: cyclophosphamide, Drug: doxorubicin hydrochloride, Drug: paclitaxel, Drug: tamoxifen citrate, Procedure: adjuvant therapy, Radiation: radiation therapyPaclitaxel IV continuously over 72 hours on days 1-3 and cyclophosphamide IV on days 1-3. Filgrastim subcutaneously (SC) beginning on day 5 and continuing until blood counts recover or pegfilgrastim SC on day 5. Treatment repeats every 21 days for 3 courses. Then doxorubicin hydrochloride IV on day 1 and filgrastim SC beginning on day 2 and continuing until blood counts recover or pegfilgrastim SC on day 2. Treatment repeats every 21 days for 4 courses. Patients with hormone-receptor positive tumors receive oral tamoxifen citrate or oral anastrozole daily for 5 years following chemotherapy. Beginning 3-6 weeks after completion of chemotherapy, patients undergo radiation therapy 5 days a week for 6-7 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 |
|---|---|---|
| filgrastimAlso: G-CSF, Neupogen®, recominant-methionyl human granulocyte-colony stimulating factor, granulocyte colony stimulating factor, r-methHuG-CSFNeupogen (G-CSF) given at a dose of 10 ugm/kg subcutaneously starting on day 5 and continuing until ANC > 10,000/uL x1 day after the nadir cycles 1-3. | Biological | Arm A: Combination Chemotherapy |
| cyclophosphamideAlso: Cytoxan®, CTX, CPM, Neosar®cyclophosphamide 700 mg/m2 daily for 3 day every 3 weeks cycles 1-3 | Drug | Arm A: Combination Chemotherapy |
| doxorubicin hydrochloridePatients then receive doxorubicin IV on day 1. | Drug | Arm A: Combination Chemotherapy |
| paclitaxelAlso: Taxol®Paclitaxel 160 mg/m2 given over 72 hours by continuous infusion days 1-3 | Drug | Arm A: Combination Chemotherapy |
| tamoxifen citratetamoxifen at a dose of 20 mg daily for 5 years after chemotherapy is completed | Drug | Arm A: Combination Chemotherapy |
| adjuvant therapyPatients receive paclitaxel IV continuously and cyclophosphamide IV over 2 hours on days 1-3. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 5 and continuing until day 14 or until blood counts recover. Treatment repeats every 21 days for 3 courses. Patients then receive doxorubicin IV on day 1 and G-CSF SC on days 2-11 every 21 days for 4 courses. | Procedure or surgery | Arm A: Combination Chemotherapy |
| radiation therapyBeginning 3-6 weeks after the completion of chemotherapy, patients receive radiotherapy 5 days a week for 6-7 weeks. | Radiation | Arm A: Combination Chemotherapy |
Primary outcome
To determine the safety of administering continuous infusion paclitaxel with dose intense cyclophosphamide
Time frame: 9 weeks
Paclitaxel 160 mg/m2 given over 72 hours by continuous infusion days 1-3 given concurrently with cyclophosphamide 700 mg/m2 daily for 3 day every 3 weeks cycles 1-3. Patients will be observed in the outpatient treatment area during the first 2 hours of the paclitaxel infusion for allergic reactions. Epinephrine, hydrocortisone, and IV antihistamine will be available.
To determine the incidence of febrile neutropenia with the first cycle of therapy.
Time frame: 3 weeks
A specific objective of this trial is to estimate the incidence of febrile neutropenia. The observed incidence of febrile neutropenia with the first cycle of cyclophosphamide and paclitaxel, as well as the observed number of days of grade ¾ neutropenia during the first treatment cycle, will be reported along with 95% confidence intervals.
5 secondary outcomes
To determine days of neutrophil counts below 500/uL on this regimen during the first treatment cycle.
Time frame: after 1st cycle (3 weeks)
To evaluate dose delays and dose reductions of this regimen.
Time frame: at 7 cycles (21 weeks)
To determine disease-free and overall survival of this regimen.
Time frame: 5 yrs after treatment
Quality of life as assessed by Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire
Time frame: 6 months after treatment
Correlation of Her2/neu overexpression with disease-free and overall survival
Time frame: 5 yrs after 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 2 Oct 2012.
- Clinical trial summary from the National Cancer Institute's PDQ® databaseLink provided by the sponsor.
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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.
Brenda W. Cooper, MD study chair
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
3 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, cyclophosphamide and doxorubicin hydrochloride in people with Breast Cancer, run by Case Comprehensive Cancer Center at 3 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 2 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 3 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?
To determine the safety of administering continuous infusion paclitaxel with dose intense cyclophosphamide (time frame: 9 weeks). The study lists 2 primary outcomes in all. 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 2 Oct 2012.