Breast NeoplasmPhase 2NCT00194753
Adjuvant Therapy for High-Risk Breast Cancer With Wkly Adriamycin & Oral Cytoxan With G-CSF for 12 Wks; Wkly Taxol x 12
A Phase 2 study testing Paclitaxel, Doxorubicin and Cyclophosphamide in people with Breast Neoplasm, run by University of Washington at 1 site in United States.
Trial summary
The primary objectives of the study are to evaluate the feasibility and toxicity of treatment with 12 weeks of Adriamycin with daily oral Cytoxan with G-CSF support followed by 12 weeks of Taxol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- Paclitaxel, Doxorubicin and Cyclophosphamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2001to Mar 2011
- 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
Who may be able to join
- Patient must have a histologically confirmed diagnosis of primary breast carcinoma that has been surgically resected. (This regimen is not intended for neoadjuvant treatment.)
- The attending physician must judge the patient to be an appropriate candidate for Adriamycin based adjuvant chemotherapy. Appropriate candidates generally include those with stage II or III breast cancer. The individual attending physician, however, should make the decision.
- Tumor HER-2/neu expression must be determined prior to study enrollment. Assessment may be by fluorescence in situ hybridization (FISH) assay or by immunocytochemistry (ICC). If determination is "intermediate" by immunocytochemistry, FISH must be performed. Protocol therapy is determined by HER-2/neu result.
- Patient must be at least 18.
- The patient must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
- Pre-study hematologic values required for entry onto trial are: WBC greater than= 4,000/mm3, ANC greater than= 1,500/mm3 and platelets greater than= 100,000/mm3.
Who cannot join
- Patients with significant renal dysfunction (creatinine greater than 1.5 x institutional upper limit of normal (IULN)) or hepatic dysfunction (bilirubin greater than IULN; transaminases greater than 2.5 x IULN) are not eligible.
- Except for the following, no prior malignancy is allowed: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient has been disease free for 5 years.
- Patients with clinically apparent cardiac disease, or history of same, are not eligible. Patients who are > 60 years of age or who have a history of hypertension must have a MUGA prior to enrollment. LVEF must be normal.
- Patients who have received prior chemotherapy or radiotherapy are not eligible.
- Patients who are pregnant or breastfeeding are not eligible. Women of child bearing potential must have a serum pregnancy test that is negative and agree to practice adequate contraception.
- Patients with active infection are not eligible.
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- Patients who are known to be infected with HIV, hepatitis B or hepatitis C are not eligible. Testing is not required unless there is a high index of clinical suspicion.
- Patients suffering from psychiatric impairment are not eligible.
- Patients with known hypersensitivity to trimethoprim or sulfonamides are not eligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington/Seattle Cancer Care Alliance
Seattle, Washington, 98109-1023
About this study
Official title: Adjuvant Therapy for High-Risk Localized Breast Cancer With Weekly Adriamycin +/- Oral Cytoxan With Continuous G-CSF Support for 12 Weeks Followed by Weekly Taxol for 12 Weeks, Phase II
The primary objectives of the study are to evaluate the feasibility and toxicity of treatment with 12 weeks of Adriamycin with daily oral Cytoxan with G-CSF support followed by 12 weeks of Taxol. Feasibility will be assessed by comparing the delivered dose intensity of each drug to the delivered dose intensity in previous trials. Toxicity will be assessed by comparing the incidence and severity of toxicity with these drugs to previous trials using these drugs in the same combination. We hypothesize metronomic, dose dense treatment as given in this study will be less toxic and more effective than historical regimens using the same drugs in a less metronomic, dose dense manner.
Read the detailed description
The systemic cancer treatments used in this study (Adriamycin, Cytoxan and Taxol) are all delivered in a dose dense, metronomic manner (weekly or daily). It is our hypothesis that dose dense treatment will result in optimum delivered dose intensity while minimizing toxicity. We will test these hypotheses by comparing the delivered dose intensity of the drugs to the delivered dose intensity of standard regimens. We will also compare time to relapse, survival and toxicity of this treatment to historic, standard regimens.
- Conditions
- Breast Neoplasm
- Being tested
- Paclitaxel, Doxorubicin, Cyclophosphamide, G-CSF
- Keywords
- 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.
PaclitaxelDrug
80 mg/m2 IV for 12 weeks following completion of doxorubicin and cyclophosphamide
DoxorubicinDrug
24 mg/m2 IV weekly x 12
CyclophosphamideDrug
60 mg/m2 PO daily for 12 weeks
G-CSFDrug
5 mcg per kg subcutaneously days 2 - 7 during doxorubicin and cyclophosphamide for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Weekly doxorubicin (24 mg/m2 IV) with daily oral cyclophosphamide (60 mg/m2 PO) for 12 weeks with G-CSF support days 2 - 7 of each week followed by weekly paclitaxel (80 mg/m2 IV) for 12 weeks. Receives: Drug: Paclitaxel; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: G-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delivered dose intensity
Measured: 24 weeks
Toxicity
Measured: 24 weeks
Secondary outcomes (2)
Time to treatment failure
Measured: 7 years
Overall survival
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startDec 2001
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen, Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Georgiana K. Ellis, M.D., Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00194753
- Sponsor's protocol ID
- 18229-A
- Other IDs
- 00-5889-A 07
- Status last verified
- Sep 2012
- First submitted
- 14 Sep 2005
- Last updated
- 13 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Therapy for High-Risk Localized Breast Cancer With Weekly Adriamycin +/- Oral Cytoxan With Continuous G-CSF Support for 12 Weeks Followed by Weekly Taxol for 12 Weeks, Phase II
- ClinicalTrials.gov ID
- NCT00194753
- Acronym / sponsor ID
- 18229-A
- Conditions
- Breast Neoplasm
- Keywords
- Breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Amgen, Bristol-Myers Squibb
- Study start
- Dec 2001
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 19 Sep 2005 (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.
The primary objectives of the study are to evaluate the feasibility and toxicity of treatment with 12 weeks of Adriamycin with daily oral Cytoxan with G-CSF support followed by 12 weeks of Taxol. Feasibility will be assessed by comparing the delivered dose intensity of each drug to the delivered dose intensity in previous trials. Toxicity will be assessed by comparing the incidence and severity of toxicity with these drugs to previous trials using these drugs in the same combination. We hypothesize metronomic, dose dense treatment as given in this study will be less toxic and more effective than historical regimens using the same drugs in a less metronomic, dose dense manner.
Detailed description
The systemic cancer treatments used in this study (Adriamycin, Cytoxan and Taxol) are all delivered in a dose dense, metronomic manner (weekly or daily). It is our hypothesis that dose dense treatment will result in optimum delivered dose intensity while minimizing toxicity. We will test these hypotheses by comparing the delivered dose intensity of the drugs to the delivered dose intensity of standard regimens. We will also compare time to relapse, survival and toxicity of this treatment to historic, standard regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Paclitaxel, Drug: Doxorubicin, Drug: Cyclophosphamide, Drug: G-CSFWeekly doxorubicin (24 mg/m2 IV) with daily oral cyclophosphamide (60 mg/m2 PO) for 12 weeks with G-CSF support days 2 - 7 of each week followed by weekly paclitaxel (80 mg/m2 IV) for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient must have a histologically confirmed diagnosis of primary breast carcinoma that has been surgically resected. (This regimen is not intended for neoadjuvant treatment.)
- The attending physician must judge the patient to be an appropriate candidate for Adriamycin based adjuvant chemotherapy. Appropriate candidates generally include those with stage II or III breast cancer. The individual attending physician, however, should make the decision.
- Tumor HER-2/neu expression must be determined prior to study enrollment. Assessment may be by fluorescence in situ hybridization (FISH) assay or by immunocytochemistry (ICC). If determination is "intermediate" by immunocytochemistry, FISH must be performed. Protocol therapy is determined by HER-2/neu result.
- Patient must be at least 18.
- The patient must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
Key exclusion criteria (9 listed)
- Patients with significant renal dysfunction (creatinine greater than 1.5 x institutional upper limit of normal (IULN)) or hepatic dysfunction (bilirubin greater than IULN; transaminases greater than 2.5 x IULN) are not eligible.
- Except for the following, no prior malignancy is allowed: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient has been disease free for 5 years.
- Patients with clinically apparent cardiac disease, or history of same, are not eligible. Patients who are > 60 years of age or who have a history of hypertension must have a MUGA prior to enrollment. LVEF must be normal.
- Patients who have received prior chemotherapy or radiotherapy are not eligible.
- Patients who are pregnant or breastfeeding are not eligible. Women of child bearing potential must have a serum pregnancy test that is negative and agree to practice adequate contraception.
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 |
|---|---|---|
| Paclitaxel80 mg/m2 IV for 12 weeks following completion of doxorubicin and cyclophosphamide | Drug | 1 |
| Doxorubicin24 mg/m2 IV weekly x 12 | Drug | 1 |
| Cyclophosphamide60 mg/m2 PO daily for 12 weeks | Drug | 1 |
| G-CSF5 mcg per kg subcutaneously days 2 - 7 during doxorubicin and cyclophosphamide for 12 weeks | Drug | 1 |
Primary outcome
Delivered dose intensity
Time frame: 24 weeks
Toxicity
Time frame: 24 weeks
2 secondary outcomes
Time to treatment failure
Time frame: 7 years
Overall survival
Time frame: 7 years
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 13 Sep 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.
Georgiana K. Ellis, M.D. principal investigator
University of Washington
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 Paclitaxel, Doxorubicin and Cyclophosphamide in people with Breast Neoplasm, run by University of Washington 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?
The sponsor lists 6 inclusion and 9 exclusion criteria. 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 13 Sep 2012. 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?
Delivered dose intensity (time frame: 24 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 13 Sep 2012.