Breast NeoplasmsPhase 2NCT00046514
ABI-007 in Taxol Resistant Patients With Metastatic Breast Cancer
A Phase 2 study testing ABI-007 in people with Breast Neoplasms and Metastases, Neoplasm, run by Celgene Corporation at 1 site in United States.
Trial summary
The anticancer agent paclitaxel (marketed as Taxol) has shown remarkable activity against metastatic breast cancer. However, the Taxol formulation requires prolonged administration times, and there are safety problems that have been attributed to the solvent rather than the active ingredient, paclitaxel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms, Metastases, Neoplasm
- What is being tested?
- ABI-007
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2001to not given
- 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
Patients must be:
- If female, non-pregnant and not lactating, with a negative serum pregnancy test, and either not of child-bearing potential or practicing an approved contraception method
- Eighteen years of age or older
- Karnofsky Perfomance Status of 70% or 0-2 SWOG Performance Status
- No other malignancy, except non-melanoma skin cancer, CIN, or in-situ cervical cancer
- Measurable disease
- Suitable candidate for treatment with paclitaxel
- Previously treated with Taxol weekly or every three weeks, including adjuvant therapy, for metastatic breast cancer and relapsed within 12 months
- If, at baseline, patient has absolute neutrophil count of at least 1500 cells/mm3, platelet count of at least 100,000 cells/mm3,and hemoglobin of at least 9 g/dL
- If, at baseline, patient has AST and ALT of less than or equal to 2.5 x the upper limit of normal range; a total bilirubin less than or equal to 1.5 mg/dL; creatinine levels less than or equal to 2 mg/dL; and alkaline phosphatase levels less than or equal to 5 x the upper limit of normal range (unless there are bone but not liver metastases)
- Patient has an expected survival of at least 12 weeks
- Patient or his/her representative has signed an informed consent statement
Trial locations and contacts
1 site in 1 country.
United States1 site
Abraxis BioScience, Inc.
Raleigh, North Carolina, 27609
About this study
Official title: A Phase II Clinical Trial of ABI-007 (A Cremophor-Free, Protein Stabilized, Nanoparticle Paclitaxel)Administered Weekly in Taxol Resistant Patients With Metastatic Breast Cancer
The anticancer agent paclitaxel (marketed as Taxol) has shown remarkable activity against metastatic breast cancer. However, the Taxol formulation requires prolonged administration times, and there are safety problems that have been attributed to the solvent rather than the active ingredient, paclitaxel. This is a new formulation of paclitaxel that has been found to have fewer safety problems than Taxol, and may be administered safely at higher doses. This study will investigate the safety and efficacy of this new formulation of paclitaxel given intravenously once a week for three weeks, followed by a rest week. This cycle will be repeated until safety problems or treatment failure require that the patient stop therapy.
Read the detailed description
The anticancer agent paclitaxel (Taxol for Injection Concentrate, Bristol-Meyers Squibb) has a broad spectrum of activity against several human cancers including carcinomas of ovary, breast, lung, esophagus and head and neck cancer. Taxol has shown remarkable activity against metastatic breast cancer, yielding response rates in the range of 40% to 60% in chemotherapy-naive patients and 25%-30% in patients refractory to anthracycline-containing regimens (Taxol package insert). The major limitation of Taxol is its poor water soluability requiring Cremophor (containing castor oil and ethanol) as a solvent. Taxol in this vehicle must be administered over 3-24 hours, and hypersensitivity reactions to Cremophor require a premedication routine of a corticosteroid, an antihistamine, and an H2 antagonist.
In this study, the test medication (ABI-007) is a nanoparticle colloidal composition of protein-stabilized paclitaxel that is reconstituted in saline. The infusion time for ABI-007 is minimal compared to Taxol (under an hour), and there is no premedication required. The maximally tolerated dose of this formulation of paclitaxel is 300 mg/m2, as compared to 175 mg/m2 for Taxol. As tumor response has been shown to be dose-dependent for paclitaxel, a higher dose allows for a potentially better response.
This open-label, Phase II study will determine the safety, tolerability and anti-tumor effect of ABI-007 monotherapy administered weekly in patients with metastatic breast cancer that have been previously treated with Taxol.
- Conditions
- Breast Neoplasms, Metastases, Neoplasm
- Being tested
- ABI-007
- Keywords
- Metastatic Breast Cancer, Taxol
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABI-007Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2002 (estimated)
- Study startJun 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Celgene Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael J Hawkins, M.D., Study director, Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00046514
- Sponsor's protocol ID
- CA013
- Status last verified
- Dec 2016
- First submitted
- 30 Sep 2002
- Last updated
- 15 Dec 2016
- Results posted
- No
Publications
Blum JL, Savin MA, Edelman G, Pippen JE, Robert NJ, Geister BV, Kirby RL, Clawson A, O'Shaughnessy JA. Phase II study of weekly albumin-bound paclitaxel for patients with metastatic breast cancer heavily pretreated with taxanes. Clin Breast Cancer. 2007 Dec;7(11):850-6. doi: 10.3816/CBC.2007.n.049.
PubMed 18269774
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial of ABI-007 (A Cremophor-Free, Protein Stabilized, Nanoparticle Paclitaxel)Administered Weekly in Taxol Resistant Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00046514
- Acronym / sponsor ID
- CA013
- Conditions
- Breast Neoplasms, Metastases, Neoplasm
- Keywords
- Metastatic Breast Cancer, Taxol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Celgene CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2001
- First posted
- 3 Oct 2002 (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 anticancer agent paclitaxel (marketed as Taxol) has shown remarkable activity against metastatic breast cancer. However, the Taxol formulation requires prolonged administration times, and there are safety problems that have been attributed to the solvent rather than the active ingredient, paclitaxel. This is a new formulation of paclitaxel that has been found to have fewer safety problems than Taxol, and may be administered safely at higher doses. This study will investigate the safety and efficacy of this new formulation of paclitaxel given intravenously once a week for three weeks, followed by a rest week. This cycle will be repeated until safety problems or treatment failure require that the patient stop therapy.
Detailed description
The anticancer agent paclitaxel (Taxol for Injection Concentrate, Bristol-Meyers Squibb) has a broad spectrum of activity against several human cancers including carcinomas of ovary, breast, lung, esophagus and head and neck cancer. Taxol has shown remarkable activity against metastatic breast cancer, yielding response rates in the range of 40% to 60% in chemotherapy-naive patients and 25%-30% in patients refractory to anthracycline-containing regimens (Taxol package insert). The major limitation of Taxol is its poor water soluability requiring Cremophor (containing castor oil and ethanol) as a solvent. Taxol in this vehicle must be administered over 3-24 hours, and hypersensitivity reactions to Cremophor require a premedication routine of a corticosteroid, an antihistamine, and an H2 antagonist.
In this study, the test medication (ABI-007) is a nanoparticle colloidal composition of protein-stabilized paclitaxel that is reconstituted in saline. The infusion time for ABI-007 is minimal compared to Taxol (under an hour), and there is no premedication required. The maximally tolerated dose of this formulation of paclitaxel is 300 mg/m2, as compared to 175 mg/m2 for Taxol. As tumor response has been shown to be dose-dependent for paclitaxel, a higher dose allows for a potentially better response.
This open-label, Phase II study will determine the safety, tolerability and anti-tumor effect of ABI-007 monotherapy administered weekly in patients with metastatic breast cancer that have been previously treated with Taxol.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
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 |
|---|---|---|
| ABI-007 | Drug | – |
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 15 Dec 2016.
- Background: PubMed 18269774Blum JL, Savin MA, Edelman G, Pippen JE, Robert NJ, Geister BV, Kirby RL, Clawson A, O'Shaughnessy JA. Phase II study of weekly albumin-bound paclitaxel for patients with metastatic breast cancer heavily pretreated with taxanes. Clin Breast Cancer. 2007 Dec;7(11):850-6. doi: 10.3816/CBC.2007.n.049.
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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.
Michael J Hawkins, M.D. study director
Celgene Corporation
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 ABI-007 in people with Breast Neoplasms and Metastases, Neoplasm, run by Celgene Corporation 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 15 Dec 2016. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00046514, which also lists 1 linked publication.
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 15 Dec 2016.