Breast CancerPhase 1NCT00003927
Combination Chemotherapy, Amifostine, and Peripheral Stem Cell Transplantation in Treating Patients With Stage II, Stage III, or Stage IV Breast Cancer
A Phase 1 study testing filgrastim, amifostine trihydrate and cyclophosphamide in people with Breast Cancer, run by City of Hope Medical 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 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 59 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- filgrastim, amifostine trihydrate and cyclophosphamide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 1999to 21 Mar 2023
- Phase
- Phase 1
- 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 59 years
- All sexes
- No healthy volunteers
- Adult
DISEASE CHARACTERISTICS: Histologically proven breast cancer including: Stage IV metastatic disease with current partial or complete response to prior induction chemotherapy High risk primary disease with less than 60% chance of progression free survival at 3 years Stage II tumors with 10 or more axillary node involvement Stage IIIA or IIIB tumors No bone marrow metastases No CNS metastases No more than 10 bone metastases Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: 59 and under Menopausal status: Not specified Performance status: Karnofsky 80-100% Life expectancy: Not specified Hematopoietic: Neutrophil count greater than 2,000/mm3 Platelet count greater than 150,000/mm3 Hemoglobin greater than 9 g/dL (blood transfusions allowed) Hepatic: Bilirubin no greater than 1.2 mg/dL SGOT or SGPT less than 1.5 times upper limit of normal Renal: Creatinine no greater than 1.2 mg/dL Creatinine clearance at least 80 mL/min No prior hemorrhagic cystitis Cardiovascular: Ejection fraction at least 55% by MUGA No prior valvular heart disease or arrhythmia Pulmonary: DLCO at least 60% lower limit of predicted pCO2 no greater than 43 mmHg on room air pO2 greater than 85 mmHg on room air FEV 1 at least 2 liters Other: No other prior malignancy except basal or squamous cell skin cancer, or carcinoma in situ or stage I carcinoma of the cervix Not pregnant HIV negative Hepatitis B negative No prior history of disabling psychosocial disorder No other CNS dysfunction
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy No more than 2 prior chemotherapy regimens for metastatic disease Prior total doxorubicin dose no greater than 180 mg/m2 Prior total paclitaxel dose no greater than 750 mg/m2 Endocrine therapy: At least 4 weeks since prior hormonal therapy Radiotherapy: At least 4 weeks since prior radiotherapy No prior radiotherapy to the left chest wall No prior radiotherapy to greater than 20% of bone marrow (excluding syngeneic transplantation candidates) Surgery: Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, 91010-3000
About this study
Official title: High-Dose Infusional Taxol, Amifostine, Doxorubicin, and Cyclophosphamide Followed by Stem Cell Rescue for High Risk Primary and Responsive 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. Amifostine may protect normal cells from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, amifostine, and peripheral stem cell transplantation in treating patients who have stage II, stage III, or stage IV breast cancer.
Read the detailed description
OBJECTIVES: I. Evaluate the feasibility of high dose doxorubicin, cyclophosphamide, paclitaxel, and amifostine in patients with high risk stage II/III and responsive stage IV advanced breast cancer. II. Determine the pharmacokinetic profile of paclitaxel administered with amifostine in this regimen in these patients. III. Assess the toxicity of this treatment regimen in this patient population.
OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously twice daily on days 1-4 for peripheral blood stem cell (PBSC) mobilization and continuing through days 5-10 during PBSC collection. At least 2 weeks following mobilization, patients receive doxorubicin IV as a continuous infusion on days -9 through -5 followed by cyclophosphamide IV over 2 hours on day -5 and amifostine IV over 15 minutes, and paclitaxel IV over 24 hours on day -4. On day -2, 25% PBSC are reinfused and 75% are reinfused on day 0, followed by daily G-CSF subcutaneously or IV beginning on day 1. Patients are followed every 3 months for 2 years, then periodically thereafter.
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study within 6-8 months.
- Conditions
- Breast Cancer
- Being tested
- filgrastim, amifostine trihydrate, cyclophosphamide, doxorubicin hydrochloride, paclitaxel
- Keywords
- stage II breast cancer, stage IV 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
amifostine trihydrateDrug
cyclophosphamideDrug
paclitaxelDrug
peripheral blood stem cell transplantationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| High Dose chemotherapy followed by cell rescue | Experimental | Doxorubicin, cyclophosphamide, Taxol, amifostine Receives: Biological: filgrastim; Drug: amifostine trihydrate; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: paclitaxel; Procedure: peripheral blood stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of high dose chemotherapy in advance breast cancer patients.
Measured: Up to death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2003 (estimated)
- Study start18 May 1999
- Primary completion21 Mar 2023
- Study completion21 Mar 2023
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 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 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
- Sayeh Lavasani, MD, Study chair, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003927
- Sponsor's protocol ID
- 99002
- Other IDs
- P30CA033572, CHNMC-IRB-99002, ALZA-CHNMC-IRB-99002, NCI-G99-1527, CDR0000067115
- Status last verified
- Jul 2023
- First submitted
- 1 Nov 1999
- Last updated
- 5 Jul 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Dose Infusional Taxol, Amifostine, Doxorubicin, and Cyclophosphamide Followed by Stem Cell Rescue for High Risk Primary and Responsive Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00003927
- Acronym / sponsor ID
- 99002
- Conditions
- Breast Cancer
- Keywords
- stage II breast cancer, stage IV breast cancer, stage IIIA breast cancer, stage IIIB breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 18 May 1999 (actual)
- Primary completion
- 21 Mar 2023 (actual)
- Study completion
- 21 Mar 2023 (actual)
- First posted
- 11 Dec 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 chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Amifostine may protect normal cells from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, amifostine, and peripheral stem cell transplantation in treating patients who have stage II, stage III, or stage IV breast cancer.
Detailed description
OBJECTIVES: I. Evaluate the feasibility of high dose doxorubicin, cyclophosphamide, paclitaxel, and amifostine in patients with high risk stage II/III and responsive stage IV advanced breast cancer. II. Determine the pharmacokinetic profile of paclitaxel administered with amifostine in this regimen in these patients. III. Assess the toxicity of this treatment regimen in this patient population.
OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously twice daily on days 1-4 for peripheral blood stem cell (PBSC) mobilization and continuing through days 5-10 during PBSC collection. At least 2 weeks following mobilization, patients receive doxorubicin IV as a continuous infusion on days -9 through -5 followed by cyclophosphamide IV over 2 hours on day -5 and amifostine IV over 15 minutes, and paclitaxel IV over 24 hours on day -4. On day -2, 25% PBSC are reinfused and 75% are reinfused on day 0, followed by daily G-CSF subcutaneously or IV beginning on day 1. Patients are followed every 3 months for 2 years, then periodically thereafter.
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study within 6-8 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High Dose chemotherapy followed by cell rescue | Experimental | Biological: filgrastim, Drug: amifostine trihydrate, Drug: cyclophosphamide, Drug: doxorubicin hydrochloride, Drug: paclitaxel, Procedure: peripheral blood stem cell transplantationDoxorubicin, cyclophosphamide, Taxol, amifostine |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| filgrastim | Biological | High Dose chemotherapy followed by cell rescue |
| amifostine trihydrate | Drug | High Dose chemotherapy followed by cell rescue |
| cyclophosphamide | Drug | High Dose chemotherapy followed by cell rescue |
| doxorubicin hydrochloride | Drug | High Dose chemotherapy followed by cell rescue |
| paclitaxel | Drug | High Dose chemotherapy followed by cell rescue |
| peripheral blood stem cell transplantation | Procedure or surgery | High Dose chemotherapy followed by cell rescue |
Primary outcome
Feasibility of high dose chemotherapy in advance breast cancer patients.
Time frame: Up to death
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 5 Jul 2023.
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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.
Sayeh Lavasani, MD study chair
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing filgrastim, amifostine trihydrate and cyclophosphamide in people with Breast Cancer, run by City of Hope Medical Center 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 5 Jul 2023. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Feasibility of high dose chemotherapy in advance breast cancer patients. (time frame: Up to death). 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 5 Jul 2023.