Breast CancerPhase 2NCT00003392
High-Dose Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Metastatic Breast Cancer
A Phase 2 study testing filgrastim, carboplatin and cyclophosphamide in people with Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 14 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 chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 65 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
- How many people
- 61 participants
- Where
- 14 sitesUnited States
- Study dates
- Sep 1997to Jan 2003
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically proven recurrent or refractory, metastatic breast cancer Patients previously treated for metastatic disease must show response to last standard dose chemotherapy regimen within 60 days of study entry OR Patients with no evidence of disease (e.g., resected skin lesions) must show no evidence of progression or bone disease No CNS metastases No disease progression following prior platinum or paclitaxel based regimens Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: 18 to 65 Sex: Not specified Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 90,000/mm3 No prior inability to mobilize adequate peripheral blood progenitor cells for high dose therapy Hepatic: Bilirubin no greater than 1.8 mg/dL Transaminases stable and no greater than 3 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: LVEF within normal limits No significant cardiovascular disease No coronary artery disease No arrhythmias No congestive heart failure Other: Not pregnant or nursing Negative pregnancy test required of fertile women Effective contraception required of fertile patients Not HIV positive No nonmalignant disease precluding protocol treatment No sensitivity to E. coli-derived drug preparations No prior participation in this study No greater than grade I neurotoxicity
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior cellular support for high dose chemotherapy Chemotherapy: See Disease Characteristics No more than 6 prior courses of chemotherapy for metastatic disease At least 3 weeks since prior chemotherapy and recovered No prior high dose chemotherapy with cellular support Endocrine therapy: No concurrent steroid therapy Concurrent hormonal therapy allowed Radiotherapy: At least 3 weeks since prior radiotherapy and recovered No prior extensive pelvic radiation Surgery: Not specified Other: Recovered from acute toxic effects of any prior therapy No concurrent anticoagulation therapy
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
University of Chicago Cancer Research Center
Chicago, Illinois, 60637
Bone Marrow Stem Cell Transplant Institute of Florida
Fort Lauderdale, Florida, 33313
Scripps Clinic
La Jolla, California, 92037
University of California San Diego
La Jolla, California, 92093
Methodist Hospital-Central Unit
Memphis, Tennessee, 38104
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Stem Cell Sciences
New York, New York, 10016
Lutheran General Cancer Care Center
Park Ridge, Illinois, 60068
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
Temple University Cancer Center
Philadelphia, Pennsylvania, 19140
University of Rochester School of Medicine
Rochester, New York, 14642
New York Medical College
Valhalla, New York, 10595
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
About this study
Official title: Multiple Cycles of High Dose Chemotherapy Supported With Filgrastim and Peripheral Blood Progenitor Cells in Patients With Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of high-dose chemotherapy and peripheral stem cell transplantation in treating patients with recurrent or refractory metastatic breast cancer.
Read the detailed description
OBJECTIVES: I. Determine the effects on 2 year progression-free survival of a regimen consisting of cyclophosphamide, paclitaxel, and filgrastim (G-CSF) to mobilize peripheral blood progenitor cells (PBPCs), followed by 2 courses of carboplatin and paclitaxel followed by 1 course of melphalan, each supported with PBPCs and G-CSF, in patients with recurrent or refractory, advanced breast cancer. II. Evaluate the feasibility of administering multiple courses of high dose chemotherapy in an outpatient setting for these patients. III. Evaluate the rate of complete response to the high dose therapy in these patients.
OUTLINE: This is a multicenter study. Patients receive mobilization therapy consisting of cyclophosphamide IV over 1 hour followed by paclitaxel IV over 3 hours, then filgrastim (G-CSF) beginning 24 hours following completion of paclitaxel and continuing through the last day of leukapheresis. Leukapheresis continues until an adequate number of CD34+ cells is collected. Following cell count recovery, patients receive 3 courses of high-dose chemotherapy: 2 courses of paclitaxel IV over 3 hours followed by carboplatin IV over 1 hour, with the first course generally within 21 days after completion of leukapheresis and the second course 21-35 days after the first; then 1 course of melphalan IV infused over 30 minutes 21-35 days after the previous carboplatin dose. Each course of chemotherapy is followed 24-48 hours later by the infusion of G-CSF-mobilized peripheral blood progenitor cells and G-CSF. Patients are followed every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 96 evaluable patients will be accrued for this study over 3 years.
- Conditions
- Breast Cancer
- Being tested
- filgrastim, carboplatin, cyclophosphamide, melphalan, paclitaxel
- 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.
filgrastimBiological
10 mcg/kg/d, day 2 through last day of leukapheresis
carboplatinDrug
18 AUC IV, approximately days 21, 42
cyclophosphamideDrug
4 gm/m2 IV, day 1
melphalanDrug
140 mg/m2 IV , approximately day 63
paclitaxelDrug
170 mg/m2 IV day 1
bone marrow ablation with stem cell supportProcedure or surgery
peripheral blood stem cell transplantationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2004 (estimated)
- Study startSep 1997
- Primary completionAug 2002
- Study completionJan 2003
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 UNC Lineberger 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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Thomas C. Shea, MD, Study chair, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003392
- Sponsor's protocol ID
- LCCC 9727
- Other IDs
- UNC-LCCC-970135, NCI-G98-1446
- Status last verified
- Feb 2012
- First submitted
- 1 Nov 1999
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Cycles of High Dose Chemotherapy Supported With Filgrastim and Peripheral Blood Progenitor Cells in Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00003392
- Acronym / sponsor ID
- LCCC 9727
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer, recurrent breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 1997
- Primary completion
- Aug 2002 (actual)
- Study completion
- Jan 2003 (actual)
- First posted
- 22 Jul 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. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of high-dose chemotherapy and peripheral stem cell transplantation in treating patients with recurrent or refractory metastatic breast cancer.
Detailed description
OBJECTIVES: I. Determine the effects on 2 year progression-free survival of a regimen consisting of cyclophosphamide, paclitaxel, and filgrastim (G-CSF) to mobilize peripheral blood progenitor cells (PBPCs), followed by 2 courses of carboplatin and paclitaxel followed by 1 course of melphalan, each supported with PBPCs and G-CSF, in patients with recurrent or refractory, advanced breast cancer. II. Evaluate the feasibility of administering multiple courses of high dose chemotherapy in an outpatient setting for these patients. III. Evaluate the rate of complete response to the high dose therapy in these patients.
OUTLINE: This is a multicenter study. Patients receive mobilization therapy consisting of cyclophosphamide IV over 1 hour followed by paclitaxel IV over 3 hours, then filgrastim (G-CSF) beginning 24 hours following completion of paclitaxel and continuing through the last day of leukapheresis. Leukapheresis continues until an adequate number of CD34+ cells is collected. Following cell count recovery, patients receive 3 courses of high-dose chemotherapy: 2 courses of paclitaxel IV over 3 hours followed by carboplatin IV over 1 hour, with the first course generally within 21 days after completion of leukapheresis and the second course 21-35 days after the first; then 1 course of melphalan IV infused over 30 minutes 21-35 days after the previous carboplatin dose. Each course of chemotherapy is followed 24-48 hours later by the infusion of G-CSF-mobilized peripheral blood progenitor cells and G-CSF. Patients are followed every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 96 evaluable patients will be accrued for this study over 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- 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 |
|---|---|---|
| filgrastim10 mcg/kg/d, day 2 through last day of leukapheresis | Biological | – |
| carboplatin18 AUC IV, approximately days 21, 42 | Drug | – |
| cyclophosphamide4 gm/m2 IV, day 1 | Drug | – |
| melphalan140 mg/m2 IV , approximately day 63 | Drug | – |
| paclitaxel170 mg/m2 IV day 1 | Drug | – |
| bone marrow ablation with stem cell support | Procedure or surgery | – |
| peripheral blood stem cell transplantation | 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 22 Feb 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.
Thomas C. Shea, MD study chair
UNC Lineberger Comprehensive Cancer Center
14 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 UNC Lineberger Comprehensive Cancer Center at 14 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 22 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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.
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 22 Feb 2012.