Breast NeoplasmsPhase 3NCT00046527
Study of ABI-007 and Taxol in Patients With Metastatic Breast Cancer
A Phase 3 study testing ABI-007 in people with Breast Neoplasms and Metastases, Neoplasm, run by Celgene Corporation at 1 site in United States.
Trial summary
Paclitaxel (Taxol, Bristol-Meyers Squibb) has been shown to be very effective against metastatic breast cancer, as well as other cancers. Because the Taxol formulation of paclitaxel is dissolved in Cremophor, an organic solvent containing castor oil, and ethanol, prolonged intravenous administration times are… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Breast Neoplasms, Metastases, Neoplasm
- What is being tested?
- ABI-007
- How many people
- 460 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2001to not given
- Phase
- Phase 3
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Patients will be eligible for this trial if:
- Female, non-pregnant, non-lactating, and, if of child-bearing potential, have a negative serum pregnancy test, and use approved contraception
- Sixteen years of age or older
- Histologically or cytologically confirmed breast cancer (stage III or IV) with evidence of inoperable local recurrence or metastasis, with measurable disease
- If patient has received taxane therapy as an adjuvant he/she has not relapsed within one year of completing adjuvant taxane
- No other malignancy present within the past 5 years, except non-melanoma skin cancer, cervical intraepithelial neoplasia or in-situ cervical cancer
- Suitable candidate for paclitaxel therapy
- Hematology levels at baseline of: absolute neutrophil count of at least 1500 cells/mm3; platelet count of at least 100,000 cells/mm3; hemoglobin of at least 9 g/dL
- Chemistry levels at baseline of: AST and ALT of less than or equal to 2.5 x the upper limit of normal, if no evidence of liver metastasis; total bilirubin of less than or equal to 1.5 mg/dL; creatinine of less than or equal to 2 mg/dL; alkaline phosphatase of less than or equal to 5 x the upper limit of normal, unless there is bone metastasis but not liver metastasis
- Expected survival of at least 12 weeks
- Patient or his/her representative has signed an informed consent form
Trial locations and contacts
1 site in 1 country.
United States1 site
Abraxis Bioscience, Inc
Durham, North Carolina, 27703
About this study
Official title: A Controlled, Randomized, Phase III, Multicenter, Open Label Study of ABI-007(a Cremophor Free, Protein Stabilized, Nanoparticle Paclitaxel) and Taxol in Patients With Metastatic Breast Cancer
Paclitaxel (Taxol, Bristol-Meyers Squibb) has been shown to be very effective against metastatic breast cancer, as well as other cancers. Because the Taxol formulation of paclitaxel is dissolved in Cremophor, an organic solvent containing castor oil, and ethanol, prolonged intravenous administration times are required; and because the solvent has caused hypersensitivity reactions, a premedication schedule is required. ABI-007 is a new anticancer medication containing the same active ingredient as Taxol, paclitaxel, but formulated as a protein-stabilized material that is suspended in salt water and administered intravenously. The time of administration is reduced, the dose of paclitaxel can be higher than is safe for Taxol, and there is no premedication required.
This study will determine the efficacy of this new formulation of paclitaxel, as compared to Taxol, for patients with metastatic breast cancer.
This is an open label comparative study, so patients will be randomly assigned to receive either the Taxol or ABI-007 forms of paclitaxel, but will know what medication they are receiving. Treatment will be repeated every three weeks unless adverse events or treatment failure require discontinuing study medication.
Read the detailed description
Taxol (Bristol-Meyers Squibb) is active against carcinomas of the ovary, breast, lung, esophagus and head and neck. A number of dose schedules of Taxol have been tested in breast cancer. Initial trials used 250 mg/m2 as a continuous infusion over 24 hours. Subsequently, shorter infusions of Taxol over three hours were tested at a dose of 175 mg/m2, with response rates of 30%-40%. Phase II studies using higher doses of Taxol at 200-250 mg/m2 had a response rate of 56% in metastatic breast cancer patients. However, at these doses, significant toxicities occurred, including neuropathy. There was a median granulocyte count nadir at 100-200 cells/mm3 for the majority of courses administered. There were also significant side effects associated with hypersensitivity to the Taxol vehicle, Cremophor-EL. These hypersensitivity reactions require a premedication schedule that includes a corticosteroid, an H2 antagonist and an antihistamine.
Abraxis BioScience is testing a reformulated form of paclitaxel without Cremophor. This formulation is a protein-stabilized, nanoparticle suspension of paclitaxel and human serum albumin in normal saline. The potential advantages of this formulation are:
- Higher tolerated doses, with greater efficacy
- Longer drug persistence in tumor as a result of the nanoparticle formulation
- Reduced infusion time
- Reduced risk of hypersensitivity with no required premedication schedule
- More rapid distribution of paclitaxel to the tissues based on pharmacokinetic data
This study will evaluate ABI-007, as compared to Taxol, in patients with metastatic breast cancer.
- Conditions
- Breast Neoplasms, Metastases, Neoplasm
- Being tested
- ABI-007
- Keywords
- Metastatic breast cancer, Taxol, Taxane
- 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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 460 participants
Sponsor and investigators
- Lead sponsor
- Celgene Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael J Hawkins, M.D., Study director, Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00046527
- Sponsor's protocol ID
- CA012-0
- Status last verified
- Oct 2004
- First submitted
- 30 Sep 2002
- Last updated
- 13 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled, Randomized, Phase III, Multicenter, Open Label Study of ABI-007(a Cremophor Free, Protein Stabilized, Nanoparticle Paclitaxel) and Taxol in Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00046527
- Acronym / sponsor ID
- CA012-0
- Conditions
- Breast Neoplasms, Metastases, Neoplasm
- Keywords
- Metastatic breast cancer, Taxol, Taxane
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 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.
Paclitaxel (Taxol, Bristol-Meyers Squibb) has been shown to be very effective against metastatic breast cancer, as well as other cancers. Because the Taxol formulation of paclitaxel is dissolved in Cremophor, an organic solvent containing castor oil, and ethanol, prolonged intravenous administration times are required; and because the solvent has caused hypersensitivity reactions, a premedication schedule is required. ABI-007 is a new anticancer medication containing the same active ingredient as Taxol, paclitaxel, but formulated as a protein-stabilized material that is suspended in salt water and administered intravenously. The time of administration is reduced, the dose of paclitaxel can be higher than is safe for Taxol, and there is no premedication required.
This study will determine the efficacy of this new formulation of paclitaxel, as compared to Taxol, for patients with metastatic breast cancer.
This is an open label comparative study, so patients will be randomly assigned to receive either the Taxol or ABI-007 forms of paclitaxel, but will know what medication they are receiving. Treatment will be repeated every three weeks unless adverse events or treatment failure require discontinuing study medication.
Detailed description
Taxol (Bristol-Meyers Squibb) is active against carcinomas of the ovary, breast, lung, esophagus and head and neck. A number of dose schedules of Taxol have been tested in breast cancer. Initial trials used 250 mg/m2 as a continuous infusion over 24 hours. Subsequently, shorter infusions of Taxol over three hours were tested at a dose of 175 mg/m2, with response rates of 30%-40%. Phase II studies using higher doses of Taxol at 200-250 mg/m2 had a response rate of 56% in metastatic breast cancer patients. However, at these doses, significant toxicities occurred, including neuropathy. There was a median granulocyte count nadir at 100-200 cells/mm3 for the majority of courses administered. There were also significant side effects associated with hypersensitivity to the Taxol vehicle, Cremophor-EL. These hypersensitivity reactions require a premedication schedule that includes a corticosteroid, an H2 antagonist and an antihistamine.
Abraxis BioScience is testing a reformulated form of paclitaxel without Cremophor. This formulation is a protein-stabilized, nanoparticle suspension of paclitaxel and human serum albumin in normal saline. The potential advantages of this formulation are:
- Higher tolerated doses, with greater efficacy
- Longer drug persistence in tumor as a result of the nanoparticle formulation
- Reduced infusion time
- Reduced risk of hypersensitivity with no required premedication schedule
- More rapid distribution of paclitaxel to the tissues based on pharmacokinetic data
This study will evaluate ABI-007, as compared to Taxol, in patients with metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 13 Jul 2006.
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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 3 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 13 Jul 2006. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 13 Jul 2006.